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1. Treatment with COLchicine in hospitalized patients affected by COVID-19: The COLVID-19 trial

Author

Perricone, C, Scarsi, M, Brucato, A, Pisano, P, Pigatto, E, Becattini, C, Cingolani, A, Tiso, F, Prota, R, Tomasoni, L, Cutolo, M, Tardella, M, Rozza, D, Zerbino, C, Andreoni, M, Poletti, V, Bartoloni, E, Gerli, R, Cafaro, G, Mendeni, M, Colombo, E, Medico, M, Cabras, P, Schiesaro, M, Franco, L, Fantoni, M, Friso, L, Gallo, V, Franceschini, F, Paolino, S, Salaffi, F, Scire, C, Zanetti, A, Diana, C, Passaro, A, Foti, R, Serino, F, Cassol, M, Bucaneve, G, Rocchi, R, Perricone C., Scarsi M., Brucato A., Pisano P., Pigatto E., Becattini C., Cingolani A., Tiso F., Prota R., Tomasoni L. R., Cutolo M., Tardella M., Rozza D., Zerbino C., Andreoni M., Poletti V., Bartoloni E., Gerli R., Cafaro G., Mendeni M., Colombo E., Medico M. D., Cabras P., Schiesaro M. G., Franco L., Fantoni M., Friso L., Gallo V., Franceschini F., Paolino S., Salaffi F., Scire C. A., Zanetti A., Diana C., Passaro A., Foti R., Serino F. S., Cassol M., Bucaneve G., Rocchi R. E., Perricone, C, Scarsi, M, Brucato, A, Pisano, P, Pigatto, E, Becattini, C, Cingolani, A, Tiso, F, Prota, R, Tomasoni, L, Cutolo, M, Tardella, M, Rozza, D, Zerbino, C, Andreoni, M, Poletti, V, Bartoloni, E, Gerli, R, Cafaro, G, Mendeni, M, Colombo, E, Medico, M, Cabras, P, Schiesaro, M, Franco, L, Fantoni, M, Friso, L, Gallo, V, Franceschini, F, Paolino, S, Salaffi, F, Scire, C, Zanetti, A, Diana, C, Passaro, A, Foti, R, Serino, F, Cassol, M, Bucaneve, G, Rocchi, R, Perricone C., Scarsi M., Brucato A., Pisano P., Pigatto E., Becattini C., Cingolani A., Tiso F., Prota R., Tomasoni L. R., Cutolo M., Tardella M., Rozza D., Zerbino C., Andreoni M., Poletti V., Bartoloni E., Gerli R., Cafaro G., Mendeni M., Colombo E., Medico M. D., Cabras P., Schiesaro M. G., Franco L., Fantoni M., Friso L., Gallo V., Franceschini F., Paolino S., Salaffi F., Scire C. A., Zanetti A., Diana C., Passaro A., Foti R., Serino F. S., Cassol M., Bucaneve G., and Rocchi R. E.

Abstract

Objective: To evaluate whether the addition of colchicine to standard of care (SOC) results in better outcomes in hospitalized patients with COVID-19. Design: This interventional, multicenter, randomized, phase 2 study, evaluated colchicine 1.5 mg/day added to SOC in hospitalized COVID-19 patients (COLVID-19 trial) and 227 patients were recruited. The primary outcome was the rate of critical disease in 30 days defined as need of mechanical ventilation, intensive care unit (ICU), or death. Results: 152 non-anti-SARS-CoV-2-vaccinated patients (colchicine vs controls: 77vs75, mean age 69.1±13.1 vs 67.9±15 years, 39% vs 33.3% females, respectively) were analyzed. There was no difference in co-primary end-points between patients treated with colchicine compared to controls (mechanical ventilation 5.2% vs 4%, ICU 1.3% vs 5.3%, death 9.1% vs 6.7%, overall 11 (14.3%) vs 10 (13.3%) patients, P=ns, respectively). Mean time to discharge was similar (colchicine vs controls 14.1±10.4 vs 14.7±8.1 days). Older age (>60 years, P=0.025), P/F<275 mmHg (P=0.005), AST>40 U/L (P<0.001), pre-existent heart (P=0.02), lung (P=0.003), upper-gastrointestinal (P=0.014), lower-gastrointestinal diseases (P=0.009) and cancer (P=0.008) were predictive of achieving the primary outcome. Diarrhoea (9.1% vs 0%, p=0.0031) and increased levels of AST at 6 days (76.9±91.8 vs 33.5±20.7 U/l, P=0.016) were more frequent in the colchicine group. Conclusion: Colchicine did not reduce the rate and the time to the critical stage. Colchicine was relatively safe although adverse hepatic effects require caution. We confirm that older (>60 years) patients with comorbidities are characterized by worse outcome.

Published
2023

2. Large-Scale Postmarketing Surveillance of Biological Drugs for Immune-Mediated Inflammatory Diseases Through an Italian Distributed Multi-Database Healthcare Network: The VALORE Project

Author

Trifiro, G., Isgro, V., Ingrasciotta, Y., Ientile, V., L'Abbate, L., Foti, S. S., Belleudi, V., Poggi, F., Fontana, A., Moretti, U., Lora, R., Sabaini, A., Senesi, I., Sorrentino, C., Puzo, M. R., Padula, A., Fusco, M., Giordana, R., Solfrini, V., Puccini, A., Rossi, P., Del Zotto, S., Leoni, O., Zanforlini, M., Ancona, D., Bavaro, V., Garau, D., Ledda, S., Scondotto, S., Allotta, A., Tuccori, M., Gini, R., Bucaneve, G., Franchini, D., Cavazzana, A., Biasi, V., Spila Alegiani, S., Massari, M., Andretta, I., Tanaglia, M., Carriero, A., Sassano, S., De Sarro, G., Mirarchi, S., Palleria, C., Sarro, C., Balestrieri, M., Rostan, S., Capuano, A., Bernardi, F. F., Trama, U., Russo, A., Fumo, M. G., Addis, A., Musicco, F., Sapigni, E., Mazzetti, I., Podetti, D., Potenza, A. M., Nikitina, V., Ricciardelli, R., Mogheiseh, N., Croce, S., Pettinelli, A., Ejlli, L., Fortino, I., Ercolanoni, M., Mazzone, A., Nisic, A., Schiatti, S., Ludergnani, M., Mancini, M., Patregnani, L., Fabbietti, P., Antonicelli, E., Mangano, A., Campomori, A., Urru, S. A., Costa, G., Guarrera, G. M., Stella, P., Serra, E., Carta, P., Vannacci, A., Lucenteforte, E., Parrilli, M., Convertino, I., De Giorgi, M., Rocchi, R. E., Rossi, M., Scroccaro, G., Deambrosis, P., Grindelli, G., Ferroni, E., Trifiro, G., Isgro, V., Ingrasciotta, Y., Ientile, V., L'Abbate, L., Foti, S. S., Belleudi, V., Poggi, F., Fontana, A., Moretti, U., Lora, R., Sabaini, A., Senesi, I., Sorrentino, C., Puzo, M. R., Padula, A., Fusco, M., Giordana, R., Solfrini, V., Puccini, A., Rossi, P., Del Zotto, S., Leoni, O., Zanforlini, M., Ancona, D., Bavaro, V., Garau, D., Ledda, S., Scondotto, S., Allotta, A., Tuccori, M., Gini, R., Bucaneve, G., Franchini, D., Cavazzana, A., Biasi, V., Spila Alegiani, S., Massari, M., Andretta, I., Tanaglia, M., Carriero, A., Sassano, S., De Sarro, G., Mirarchi, S., Palleria, C., Sarro, C., Balestrieri, M., Rostan, S., Capuano, A., Bernardi, F. F., Trama, U., Russo, A., Fumo, M. G., Addis, A., Musicco, F., Sapigni, E., Mazzetti, I., Podetti, D., Potenza, A. M., Nikitina, V., Ricciardelli, R., Mogheiseh, N., Croce, S., Pettinelli, A., Ejlli, L., Fortino, I., Ercolanoni, M., Mazzone, A., Nisic, A., Schiatti, S., Ludergnani, M., Mancini, M., Patregnani, L., Fabbietti, P., Antonicelli, E., Mangano, A., Campomori, A., Urru, S. A., Costa, G., Guarrera, G. M., Stella, P., Serra, E., Carta, P., Vannacci, A., Lucenteforte, E., Parrilli, M., Convertino, I., De Giorgi, M., Rocchi, R. E., Rossi, M., Scroccaro, G., Deambrosis, P., Grindelli, G., and Ferroni, E.

Subjects
Male, medicine.medical_specialty, Population, Postmarketing surveillance, Rate ratio, REGISTRIES, Retrospective Studie, Internal medicine, BIOSIMILARS, medicine, Adalimumab, Humans, Pharmacology (medical), Original Research Article, education, Adverse effect, ANTI-TNF THERAPY, RHEUMATOID-ARTHRITIS, RISK, PHARMACOVIGILANCE, BIOSIMILARS, EXPERIENCE, REGISTRIES, PSORIASIS, MEDICINES, ACCESS, Biosimilar Pharmaceuticals, Retrospective Studies, RISK, Delivery of Health Care, Female, Infliximab, Italy, SARS-CoV-2, COVID-19, Pharmacology, education.field_of_study, PSORIASIS, business.industry, Biosimilar, ANTI-TNF THERAPY, General Medicine, medicine.disease, RHEUMATOID-ARTHRITIS, PHARMACOVIGILANCE, MEDICINES, EXPERIENCE, Immune-mediated inflammatory diseases, ACCESS, business, Human, Biosimilar Pharmaceutical, Biotechnology, medicine.drug
Abstract

Background Biological drugs have improved the management of immune-mediated inflammatory diseases (IMIDs) despite being associated with important safety issues such as immunogenicity, infections, and malignancies in real-world settings. Objective The aim of this study was to explore the potential of a large Italian multi-database distributed network for use in the postmarketing surveillance of biological drugs, including biosimilars, in patients with IMID. Methods A retrospective cohort study was conducted using 13 Italian regional claims databases during 2010–2019. A tailor-made R-based tool developed for distributed analysis of claims data using a study-specific common data model was customized for this study. We measured the yearly prevalence of biological drug users and the frequency of switches between originator and biosimilars for infliximab, etanercept, and adalimumab separately and stratified them by calendar year and region. We then calculated the cumulative number of users and person-years (PYs) of exposure to individual biological drugs approved for IMIDs. For a number of safety outcomes (e.g., severe acute respiratory syndrome coronavirus 2 [SARS-COV-2] infection), we conducted a sample power calculation to estimate the PYs of exposure required to investigate their association with individual biological drugs approved for IMIDs, considering different strengths of association. Results From a total underlying population of almost 50 million inhabitants from 13 Italian regions, we identified 143,602 (0.3%) biological drug users, with a cumulative exposure of 507,745 PYs during the entire follow-up. The mean age ± standard deviation of biological drug users was 49.3 ± 16.3, with a female-to-male ratio of 1.2. The age-adjusted yearly prevalence of biological drug users increased threefold from 0.7 per 1000 in 2010 to 2.1 per 1000 in 2019. Overall, we identified 40,996 users of biosimilars of tumor necrosis factor (TNF)-α inhibitors (i.e., etanercept, adalimumab, and infliximab) in the years 2015–2019. Of these, 46% (N = 18,845) switched at any time between originator and biosimilars or vice versa. To investigate a moderate association (incidence rate ratio 2) between biological drugs approved for IMIDs and safety events of interest, such as optic neuritis (lowest background incidence rate 10.4/100,000 PYs) or severe infection (highest background incidence rate 4312/100,000 PYs), a total of 43,311 PYs and 104 PYs of exposure to individual biological drugs, respectively, would be required. As such, using this network, of 15 individual biological drugs approved for IMIDs, the association with those adverse events could be investigated for four (27%) and 14 (93%), respectively. Conclusion The VALORE project multi-database network has access to data on more than 140,000 biological drug users (and > 0.5 million PYs) from 13 Italian regions during the years 2010–2019, which will be further expanded with the inclusion of data from other regions and more recent calendar years. Overall, the cumulated amount of person-time of exposure to biological drugs approved for IMIDs provides enough statistical power to investigate weak/moderate associations of almost all individual compounds and the most relevant safety outcomes. Moreover, this network may offer the opportunity to investigate the interchangeability of originator and biosimilars of several TNFα inhibitors in different therapeutic areas in real-world settings. Supplementary Information The online version contains supplementary material available at 10.1007/s40259-021-00498-3.

Published
2021

7. [Trends in infective endocarditis in a medium-sized University Hospital in Italy: analysis of 232 cases]

Author

Pallotto, C, Martinelli, L, Baldelli, Franco, Bucaneve, G, Cecchini, Enisia, Malincarne, Lisa, and Pasticci, Maria Bruna

Subjects
Male, Endocarditis, Middle Aged, Diabetes Complications, Hospitals, University, Survival Rate, Treatment Outcome, Italy, Risk Factors, Humans, Female, Prospective Studies, Aged, Retrospective Studies
Abstract

The aim of this study was to evaluate the epidemiological and clinical characteristics of 232 cases of infective endocarditis (IE), admitted to the Clinica delle Malattie Infettive of Perugia Italy from 1973 to 2012. The analysis was retrospective until 2004. After this year, all the consecutive IE cases were included by utilizing the same prospective observational protocol of the Italian Study on Endocarditis (SEI). Out of 232 EI cases, 200 (86.2 %) were definite. Over the 40-year period, a statistically significant increase was observed in the patients' age, the rate of IE admissions and prosthetic device IEs. The rate of healthcare-associated IEs also increased in the last 10 years (p=NS). Diabetes mellitus was the most frequent comorbidity. There were no variations in the rate of S. aureus and streptococcal IEs. Central nervous system complications and surgery were reported in 19.4 percent and 29.3 percent of the cases, respectively. The in-hospital mortality was 18.9 percent. In conclusion, the epidemiological and clinical trends of this study are in agreement with the literature. The difference in S. aureus endocarditis, neurological complications and surgery rates may be due to the fact that this was a single centre and, for its first part, a retrospective study. A shared, multidisciplinary protocol may be useful to improve the outcome of patients with IE and its epidemiology.

Published
2014

8. Prophylaxis and treatment of bacterial infections: do we need new strategies?

Author

Micozzi, Alessandra and Bucaneve, G.

Subjects
Neutropenia, Hematologic Neoplasms, Premedication, Humans, Drug Therapy, Combination, Bacterial Infections
Abstract

Bacterial infections in patients with hematologic malignancies still represent a severe and life-treating problem. Several observational studies during the last decade have revealed that neutropenic patients with fever are a heterogeneous population with various differences regarding response to initial therapy, development of serious complications and mortality. The role of neutropenia as main risk factor for infections in hematologic patients and the definition of different level of risk related to neutrophils count and duration of neutropenia have been extensively studied and different categories of patients based on the risk of infection, mostly the condition of neutropenia, have been clearly defined. The strategies on antimicrobial therapy and supportive care in hematologic patients need to be continuously assessed, in fact new conditions favouring the occurrence of infectious complications in patients with hematologic malignancies have progressively emerged. The use of oral prophylactic antibiotics in neutropenic cancer patients is still a matter of debate. Before 2005, several trials showed how the prevention of infection can be extremely important in this setting of patients but none was conclusive. In 2005 two meta-analysis and two large randomized clinical trials gave new evidence that antibacterial prophylaxis can reduce in neutropenic patients several important outcomes including mortality. The use of the empiric antibacterial therapy represents the cornerstone of the antimicrobial strategies in the febrile neutropenic patients leading, over the span of 20 years, to a dramatic decrease of deaths: Actually beta-lactam monotherapy is commonly used for the empiric treatment of febrile neutropenia. Recently, large randomized clinical trials and meta-analysis showed that the addition of an aminoglycoside and/or a glycopeptides results in a more favourable outcome only in selected severe infections. The use of antibiotics should be prudent and safe also in neutropenic hematologic patients to prevent emergence of microbial resistance, to save costs, to reduce toxicity. For this reasons, according to the evidence, antibacterial prophylaxis should be restricted to high risk hematologic patients and empiric parenteral antibiotic monotherapy should be recommended in case of febrile neutropenia limiting the use of amynoglicosides and glycopeptides. In the next future, a major effort should be made to state in hematologic patients new risk factors which could more accurately define subgroups for targeted anti-infective strategies.

Published
2006

12. Itraconazole oral solution as prophylaxis for fungal infections in neutropenic patients with hematologic malignancies: A randomized, placebo- controlled, double-blind, multicenter trial

Author

Menichetti, F., Del Favero, A., Martino, P., Bucaneve, G., Micozzi, A., Girmenia, C., Barbabietola, G., Pagano, L., Leoni, P., Giorgina Specchia, Caiozzo, A., Raimondi, R., Mandelli, F., Cascavilla, N., Rigolin, G., Deliliers, G. L., Martino, B., Peta, A., Ricci P., Fanci, R., Plano, W., Sivera, P., Zagonel, V., Caramatti, C., Invernizzi, R., Buelli, M., Bernasconi, C., Carella, A., Damasio, E., Biasi, R., Chierichini, A., Galieni, P., Grasso, M., Jacopino, P., Morra, E., Porcellini, A., Resegotti, L., Ricciuti, F., Picardi, M., Ronconi, F., Cimino, R., Ferrandina, C., Gabbas, A., and Mettivier, V.

Subjects
Oral, Adult, Male, Microbiology (medical), medicine.medical_specialty, Antifungal Agents, Neutropenia, Adolescent, Itraconazole, Placebo, Aspergillosis, Double-Blind Method, Internal medicine, Multicenter trial, medicine, Administration, Oral, Aged, Female, Hematologic Neoplasms, Humans, Middle Aged, Mycoses, Patient Compliance, Infectious Diseases, Mycosis, Fungemia, business.industry, medicine.disease, Surgery, Chemoprophylaxis, Administration, business, medicine.drug
Abstract

To evaluate the efficacy and safety of itraconazole oral solution for preventing fungal infections, a randomized, placebo-controlled, double-blind, multicenter trial was conducted: 405 neutropenic patients with hematologic malignancies were randomly assigned to receive either itraconazole, 2.5 mg/kg every 12 hours (201 patients), or placebo (204 patients). Proven and suspected deep fungal infection occurred in 24% of itraconazole recipients and in 33% of placebo recipients, a difference of 9 percentage points (95% confidence interval [CI], 0.6% to 22.5%; P = .035). Fungemia due to Candida species was documented in 0.5% of itraconazole recipients and in 4% of placebo recipients, a difference of 3.5 percentage points (95% CI, 0.5% to 6%; P = .01). Deaths due to candidemia occurred in none of the itraconazole recipients compared with 4 placebo recipients, a difference of 2 percentage points (95% CI, 0.05% to 4%; P = .06). Aspergillus infection was documented in four itraconazole recipients (one death) and one placebo recipient (one death). Side effects causing drug interruption occurred in 18% of itraconazole recipients and 13% of placebo recipients. Itraconazole oral solution was well-tolerated and effectively prevented proven and suspected deep fungal infection as well as systemic infection and death due to Candida species.

Published
1999

20. Monotherapy with meropenem versus combination therapy with ceftazidime plus amikacin as empiric therapy for fever in granulocytopenic patients with cancer. The International Antimicrobial Therapy Cooperative Group of the European Organization for Research and Treatment of Cancer and the Gruppo Italiano Malattie Ematologiche Maligne dell'Adulto Infection Program

Author

Cometta, A, primary, Calandra, T, additional, Gaya, H, additional, Zinner, S H, additional, de Bock, R, additional, Del Favero, A, additional, Bucaneve, G, additional, Crokaert, F, additional, Kern, W V, additional, Klastersky, J, additional, Langenaeken, I, additional, Micozzi, A, additional, Padmos, A, additional, Paesmans, M, additional, Viscoli, C, additional, and Glauser, M P, additional

Published
1996
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22. The need for aminoglycosides in combination with ß-lactams for high-risk, febrile neutropaenic patients with leukaemia.

Author

Drgona L, Paul M, Bucaneve G, Calandra T, and Menichetti F

Abstract

The efficacy and safety of aminoglycosides given in combination with beta-lactams for the treatment of febrile neutropaenia in patients with acute leukaemia or bone marrow trans-plantation was assessed using an evidence-based review of the literature with the aim to formulate treatment guidelines. These recommendations have been developed by an expert panel of the European Conference on Infections in Leukaemic patients (ECIL-1). We also present results of a questionnaire on current treatment practice in Europe. The expert panel concluded that beta-lactam monotherapy is as efficacious as and less toxic than beta-lactam-aminoglycoside combination therapy as empirical therapy. The choice of beta-lactam should be based on local epidemiological data, antibiotic resistance patterns, recent beta-lactam use and available evidence. Combination therapy should be reserved for patients presenting with severe sepsis or septic shock or for those with a high suspicion of resistant Gram-negative infections, pending susceptibility testing and institution of appropriate beta-lactam monotherapy. [ABSTRACT FROM AUTHOR]

Published
2007
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25. Cost analysis of 2 empiric antibacterial regimens containing glycopeptides for the treatment of febrile neutropenia in patients with acute leukaemia.

Author

Bucaneve, G., Menichetti, F., Favero, A.D., and Del Favero, A

Subjects
*FEBRILE neutropenia, *LEUKEMIA, *ANTIBACTERIAL agents, *MEDICAL care costs, *THERAPEUTICS
Abstract

Objective: Patients with cancer-associated neutropenia are at high risk of developing severe infections which can be fatal if treatment is not promptly administered. For this reason, fever is treated as soon as possible with broad spectrum antibacterial therapy. The objective of this study was to conduct a cost analysis in Italy comparing 2 empiric glycoprotein-containing antibacterial regimens for the treatment of febrile neutropenia in patients with acute leukaemia.Design and Setting: A retrospective cost analysis was conducted, using the records of 527 febrile neutropenic patients with acute leukaemia who participated in an 18-month multicentre (29 Italian haematological units) randomised trial during 1991. All patients received either of the following 2 empiric intravenous regimens, each containing 3 antibacterial agents: ceftazidime (2 g, 3 times daily) and amikacin (15 mg/kg/day, in 3 separate doses) plus teicoplanin (6 mg/kg, in a single dose) or vancomycin (30 mg/kg/day, in 2 separate doses). Economic analyses were carried out from a hospital perspective. Only the direct costs per patient, i.e. mean antibacterial treatment and management cost, mean overall treatment failure cost and mean cost of adverse effects, were included.Main Outcome Measures and Results: No differences were found in the clinical response, defined as the improvement in the rate of fever or infection (if documented), between the 2 regimens. However, tolerability, defined as the incidence of adverse effects probably or definitely related to the assigned treatment, was reported to be better with the teicoplanin-rather than the vancomycin-containing regimen.Conclusions: Thus retrospective cost analysis showed that despite the higher acquisition cost of teicoplanin relative to vancomycin, the lower incidence of adverse effects associated with teicoplanin and its ease of administration (single daily dose) resulted in equivalent overall treatment costs between teicoplanin- and vancomycin containing regimens. [ABSTRACT FROM AUTHOR]

Published
1999
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26. Preventing fungal infection in neutropenic patients with acute leukemia: fluconazole compared with oral amphotericin B.

Author

Menichetti, Francisco, Favero, Albano Del, Martino, Piero, Bucaneve, Giampolo, Micozzi, Alessandra, D'Antonio, Domenico, Ricci, Paolo, Carotenuto, Mario, Liso, Vincenzo, Nosari, Anna Maria, Barbui, Tiziano, Fasola, Giampiero, Mandelli, Franco, Menichetti, F, Del Favero, A, Martino, P, Bucaneve, G, Micozzi, A, D'Antonio, D, and Ricci, P

Subjects
AMPHOTERICIN B, MYCOSES, FUNGI, CANCER chemotherapy, LEUKEMIA, ANTINEOPLASTIC agents, CLINICAL trials, COMPARATIVE studies, RESEARCH methodology, MEDICAL cooperation, NEUTROPENIA, ORAL drug administration, PATIENT compliance, RESEARCH, CUTANEOUS therapeutics, EVALUATION research, RANDOMIZED controlled trials, TREATMENT effectiveness, ACUTE diseases, FLUCONAZOLE, DISEASE complications, THERAPEUTICS
Abstract

Objective: To compare the efficacy and tolerability of fluconazole and oral amphotericin B in preventing fungal infection in neutropenic patients with acute leukemia.Design: A randomized, controlled, multicenter trial.Setting: 30 hematologic units in tertiary care or university hospitals.Patients: 820 consecutive, afebrile, adult patients with acute leukemia and chemotherapy-induced neutropenia.Intervention: Patients were randomly assigned to receive fluconazole, 150 mg, as a once-daily capsule, or amphotericin B suspension, 500 mg every 6 hours.Measurements: An intention-to-treat analysis was done for 820 patients: 420 treated with fluconazole and 400 treated with oral amphotericin B.Results: Definite systemic fungal infection occurred in 2.6% of fluconazole recipients and 2.5% of amphotericin B recipients; suspected systemic fungal infection requiring the empiric use of intravenous amphotericin B occurred in 16% of fluconazole recipients and 21% of oral amphotericin B recipients, a difference of 5 percentage points (95% CI for difference, -0.02% to 10%; P = 0.07). Superficial fungal infection was documented in 1.7% of fluconazole recipients compared with 2.7% of amphotericin B recipients, a difference of one percentage point (CI of difference, -0.9% to 3%; P > 0.2). The distribution of fungal isolates in systemic and superficial fungal infection was similar in both groups. The overall mortality rate accounted for 10% in both groups. An excellent compliance was documented for 90% of patients treated with fluconazole compared with 72% of those treated with amphotericin B suspension, a difference of 18 percentage points (CI for difference, 13% to 23%). Side effects were documented less frequently in fluconazole than in amphotericin B recipients (1.4% compared with 7%, a difference of 5.6 percentage points; CI for difference, 2% to 8%; P < 0.01).Conclusion: Fluconazole was at least as effective as oral amphotericin B in preventing systemic and superficial fungal infection and the empiric use of amphotericin B in neutropenic patients with acute leukemia but was better tolerated. [ABSTRACT FROM AUTHOR]

Published
1994
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27. Double-blind, placebo-controlled study on effects of diclofenac sodium and indomethacin on postprandial gastric motility in man.

Author

Bassotti, Gabrio, Bucaneve, Giampaolo, Furno, Paolo, Morelli, Antonio, Favero, Albano, Bassotti, G, Bucaneve, G, Furno, P, Morelli, A, and Del Favero, A

Abstract

Data from animal studies suggest that NSAIDs-induced gastric damage may be due to increased gastric motility. Such a mechanism, however, has never been tested or demonstrated in man. We evaluated the effects of two frequently prescribed NSAIDs, indomethacin and diclofenac sodium, on postprandial gastric motor activity (a physiologically reproducible stimulus) in healthy volunteers to see whether these compounds increase gastric motility. Twenty-four healthy volunteers of both sexes, 21-35 years of age, underwent a basal gastric motility recording. Thereafter, they were randomized in three groups to receive either placebo, indomethacin (50 mg three times a day) or diclofenac sodium (50 mg three times a day) for a week. At the end of the week, they underwent an identical manometric study. Analysis of the motility tracings showed no difference in gastric antral motility index and in amplitude of gastric antral contractions after NSAIDs with respect to the basal study and to the placebo group. About 50% of subjects (two in the placebo group) complained of side effects. These were transient and mild, except in two subjects taking indomethacin, in whom endoscopy was necessary; one of these had a small prepyloric ulcer. It is concluded that in man NSAID-related gastric damage is unlikely to be due to increased gastric motility. [ABSTRACT FROM AUTHOR]

Published
1998
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30. Effects of the new glycopeptide antibiotic teicoplanin on platelet function and blood coagulation

Author

Agnelli, G, Longetti, M, Guerciolini, R, Menichetti, F, Grasselli, S, Boldrini, F, Bucaneve, G, Nenci, G G, and Del Favero, A

Abstract

Teicoplanin, a new glycopeptide antibiotic, is structurally related to ristocetin, an antibiotic known to induce human platelet agglutination and, thus, thrombocytopenia and thromboembolic side effects. The aim of this study was to evaluate the effects of teicoplanin on platelet function in vitro and ex vivo and on blood coagulation ex vivo. In the in vitro studies, spontaneous platelet aggregation; platelet aggregation induced by ADP, collagen, and ristocetin; and the release of beta-thromboglobulin from platelets were assessed. Platelets from healthy subjects were incubated with teicoplanin at final concentrations of 100, 1,500, 5,000, and 10,000 micrograms/ml. The maximal achievable concentration with therapeutic doses is 100 micrograms/ml. When compared with saline, teicoplanin at concentrations of 100 and 1,500 micrograms/ml had no effect on platelet function, but at concentrations of 5,000 and 10,000 micrograms/ml, it induced greater spontaneous platelet aggregation (P less than 0.01) and inhibited platelet aggregation induced by ADP, collagen, and ristocetin (P less than 0.01). Teicoplanin at concentrations of 100, 1,500, and 5,000 micrograms/ml did not induce the release of beta-thromboglobulin, in contrast to teicoplanin at a concentration of 10,000 micrograms/ml and ristocetin at a concentration of 1.5 mg/ml (P less than 0.01). In the ex vivo studies, platelet count, bleeding time, plasma beta-thromboglobulin, platelet aggregation induced by ADP, ristocetin, and epinephrine, activated partial thromboplastin time, prothrombin time, thrombin clotting time, and serum fibrinogen degradation products were evaluated at days 0, 3, and 6 and at 72 h after the end of therapy. All subjects completed the study without evidence of side effects. When compared with the pretreatment values, none of the values from these assays showed a significant change at any time during and after treatment. We concluded that platelet function and blood coagulation are not affected by therapeutic concentrations of teicoplanin and that in vitro platelet function is affected only by concentrations of teicoplanin far in excess of those that are clinically achievable.

Published
1987
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31. Prospective randomized clinical trial of teicoplanin for empiric combined antibiotic therapy in febrile, granulocytopenic acute leukemia patients

Author

Del Favero, A, Menichetti, F, Guerciolini, R, Bucaneve, G, Baldelli, F, Aversa, F, Terenzi, A, Davis, S, and Pauluzzi, S

Abstract

The increasing prevalence of bacteremia caused by gram-positive bacteria in granulocytopenic acute leukemia patients prompted us to evaluate, in a prospective randomized trial, the role of teicoplanin, a new glycopeptide antibiotic, when it was added to amikacin plus ceftazidime, as an empiric therapy of fever in these patients. Of 47 evaluable episodes, 22 were treated with the teicoplanin regimen and 25 were treated with the combination of amikacin and ceftazidime. The overall response to therapy of patients treated with teicoplanin was slightly better (82% improvement) than that obtained with amikacin plus ceftazidime (52%). The response rate of patients with gram-positive bacteremias was 80% (4 of 5) to the regimen that included teicoplanin; 25% (1 of 4) of the patients treated with amikacin plus ceftazidime responded to treatment; and for patients with gram-negative bacteremias, the response rates were, respectively, 100% (4 of 4) and 70% (7 of 10). The better results obtained with amikacin-ceftazidime-teicoplanin treatment were most evident in patients with profound (less than 100/mm3) and persistent neutropenia (83 versus 30% improvement). Furthermore, a good response rate of patients with gram-positive bacteremias (seven of eight; 87% improvement) was achieved in a small group of bone marrow transplant patients who were all treated with amikacin-ceftazidime-teicoplanin. No severe side effects were documented in any patient. Teicoplanin, as a drug administered as a single daily dose, seems to be a safe and useful anti-gram-positive agent when used in combination with amikacin-ceftazidime as an empiric therapy of febrile episodes in granulocytopenic acute leukemia patients.

Published
1987
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37. Treatment with COLchicine in hospitalized patients affected by COVID-19: The COLVID-19 trial

Author

Carlo Perricone, Mirko Scarsi, Antonio Brucato, Paola Pisano, Erika Pigatto, Cecilia Becattini, Antonella Cingolani, Francesco Tiso, Roberto Prota, Lina Rachele Tomasoni, Maurizio Cutolo, Marika Tardella, Davide Rozza, Carlo Zerbino, Massimo Andreoni, Venerino Poletti, Elena Bartoloni, Roberto Gerli, Giacomo Cafaro, Monia Mendeni, Enrico Colombo, Marta Del Medico, Paola Cabras, Mauro Giovanni Schiesaro, Laura Franco, Massimo Fantoni, Lara Friso, Valter Gallo, Franco Franceschini, Sabrina Paolino, Fausto Salaffi, Carlo Scirè, Anna Zanetti, Claudia Diana, Angelina Passaro, Rosario Foti, Francesco Saverio Serino, Maurizio Cassol, Giampaolo Bucaneve, Rosalba Elisabetta Rocchi, Perricone, C, Scarsi, M, Brucato, A, Pisano, P, Pigatto, E, Becattini, C, Cingolani, A, Tiso, F, Prota, R, Tomasoni, L, Cutolo, M, Tardella, M, Rozza, D, Zerbino, C, Andreoni, M, Poletti, V, Bartoloni, E, Gerli, R, Cafaro, G, Mendeni, M, Colombo, E, Medico, M, Cabras, P, Schiesaro, M, Franco, L, Fantoni, M, Friso, L, Gallo, V, Franceschini, F, Paolino, S, Salaffi, F, Scire, C, Zanetti, A, Diana, C, Passaro, A, Foti, R, Serino, F, Cassol, M, Bucaneve, G, and Rocchi, R

Subjects
Coronavirus, Inflammation, Anti-IL-1, COVID-19, Colchicine, SARS-CoV-2, Settore MED/09 - Medicina Interna, Coronaviru, Internal Medicine
Abstract

Objective: To evaluate whether the addition of colchicine to standard of care (SOC) results in better outcomes in hospitalized patients with COVID-19. Design: This interventional, multicenter, randomized, phase 2 study, evaluated colchicine 1.5 mg/day added to SOC in hospitalized COVID-19 patients (COLVID-19 trial) and 227 patients were recruited. The primary outcome was the rate of critical disease in 30 days defined as need of mechanical ventilation, intensive care unit (ICU), or death. Results: 152 non-anti-SARS-CoV-2-vaccinated patients (colchicine vs controls: 77vs75, mean age 69.1±13.1 vs 67.9±15 years, 39% vs 33.3% females, respectively) were analyzed. There was no difference in co-primary end-points between patients treated with colchicine compared to controls (mechanical ventilation 5.2% vs 4%, ICU 1.3% vs 5.3%, death 9.1% vs 6.7%, overall 11 (14.3%) vs 10 (13.3%) patients, P=ns, respectively). Mean time to discharge was similar (colchicine vs controls 14.1±10.4 vs 14.7±8.1 days). Older age (>60 years, P=0.025), P/F40 U/L (P60 years) patients with comorbidities are characterized by worse outcome.

Published
2023

38. Antibacterial prophylaxis in patients with cancer and neutropenia.

Author

Freifeld AG, Sepkowitz KA, Almyroudis NG, Segal BH, Castagna L, Santoro A, Pasqualotto AC, Rosa DD, Machado AL, Ito JI, Tegtmeier BR, O'Donnell MR, Eller P, Pechlaner C, Del Favero A, Bucaneve G, Martino P, Steven N, Billingham L, and Cullen M

Published
2006

39. Results of a multicenter, controlled, randomized clinical trial evaluating the combination of piperacillin/tazobactam and tigecycline in high-risk hematologic patients with cancer with febrile neutropenia

Author

Monica Bocchia, Laura Cudillo, Anna Chierichini, Massimo Offidani, Rosa Fanci, Francesco Fabbiano, Nicola Cascavilla, Bruno Martino, Giovanni Martinelli, Giuseppe Gentile, Robin Foà, Annunziata Manna, Antonella Ferrari, Mario Luppi, Giorgina Specchia, Giovanni Quarta, Valeria Primon, Giuseppe Milone, Giampaolo Bucaneve, Marco Picardi, Albano Del Favero, Stelvio Ballanti, Eliana Zuffa, Prassede Salutari, Renato Cantaffa, Alessandra Micozzi, Bucaneve, G, Micozzi, A, Picardi, Marco, Ballanti, S, Cascavilla, N, Salutari, P, Specchia, G, Fanci, R, Luppi, M, Cudillo, L, Cantaffa, R, Milone, G, Bocchia, M, Martinelli, G, Offidani, M, Chierichini, A, Fabbiano, F, Quarta, G, Primon, V, Martino, B, Manna, A, Zuffa, E, Ferrari, A, Gentile, G, Fo?, R, and Del Favero, A.

Subjects
Adult, Male, Cancer Research, medicine.medical_specialty, Adolescent, Combination therapy, Penicillanic Acid, Aged, Anti-Bacterial Agents, Antineoplastic Agents, Bacteremia, Chemotherapy-Induced Febrile Neutropenia, Drug Combinations, Female, Hematologic Neoplasms, Humans, Middle Aged, Minocycline, Piperacillin, Risk Factors, Young Adult, Tigecycline, Tazobactam, Loading dose, law.invention, Randomized controlled trial, law, piperacillin/tazobactam and tigecycline, Internal medicine, medicine, high-risk hematologic patient, business.industry, medicine.disease, Surgery, febrile neutropenia, Oncology, Piperacillin/tazobactam, business, Settore MED/15 - Malattie del Sangue, Febrile neutropenia, medicine.drug
Abstract

Purpose Empiric antibiotic monotherapy is considered the standard of treatment for febrile neutropenic patients with cancer, but this approach may be inadequate because of the increasing prevalence of infections caused by multidrug resistant (MDR) bacteria. Patients and Methods In this multicenter, open-label, randomized, superiority trial, adult, febrile, high-risk neutropenic patients (FhrNPs) with hematologic malignancies were randomly assigned to receive piperacillin/tazobactam (4.5 g intravenously every 8 hours) with or without tigecycline (50 mg intravenously every 12 hours; loading dose 100 mg). The primary end point was resolution of febrile episode without modifications of the initial allocated treatment. Results Three hundred ninety FhrNPs were enrolled (combination/monotherapy, 187/203) and were included in the intention-to-treat analysis (ITTA). The ITTA revealed a successful outcome in 67.9% v 44.3% of patients who had received combination therapy and monotherapy, respectively (127/187 v 90/203; absolute difference in risk (adr), 23.6%; 95% CI, 14% to 33%; P < .001). The combination regimen proved better than monotherapy in bacteremias (adr, 32.8%; 95% CI, 19% to 46%; P < .001) and in clinically documented infections (adr, 36%; 95% CI, 9% to 64%; P < .01). Mortality and number of adverse effects were limited and similar in the two groups. Conclusion The combination of piperacillin/tazobactam and tigecycline is safe, well tolerated, and more effective than piperacillin/tazobactam alone in febrile, high-risk, neutropenic hematologic patients with cancer. In epidemiologic settings characterized by a high prevalence of infections because of MDR microorganisms, this combination could be considered as one of the first-line empiric antibiotic therapies.

Published
2014

40. The Importance of Real-World Data in Evaluating the Safety of Biosimilars: A Descriptive Study of Clinical Practice in an Oncohematological Italian Population.

Author

Urru SAM, Mayer F, Spila Alegiani S, Paoloni F, Guella A, Murru R, Bucaneve G, Formoso G, Racanelli V, Ferrarini I, Fozza C, Longo G, Musicco F, and Campomori A

Abstract

The clinical safety and efficacy of rituximab biosimilars compared to the reference rituximab (Mabthera) have been well established in randomized trials. However, concerns persist regarding the safety of changing from the reference product to biosimilars, and particularly between different biosimilars. This prospective multicenter observational study was conducted in 13 oncohematology units of eight Italian regions. The study included 800 patients with non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL) who received rituximab between March 2018 and June 2022. To minimize survivorship bias, only newly diagnosed patients (i.e., those without prior rituximab treatment) were included in the analysis of adverse drug reactions (ADRs). Thus, this study focused on 505 incident cases (79.8% of the initial cohort) from 13 centers. A total of 3681 rituximab infusions were administered, and 16.8% of the patients experienced at least one ADR. These were observed most frequently during the first infusion (44 patients, 52%) and the second infusion (17 patients, 20%). The most frequent reactions were general disorders and administration site conditions (n. 50, 8% serious). These findings support the clinical safety of rituximab biosimilars and suggest that switching between biosimilars does not increase the risk of adverse events. This evidence may alleviate concerns about biosimilar use, potentially leading to broader acceptance and reduced healthcare costs.

Published
2024
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41. Use of antidepressant and antipsychotic drugs in subjects with hemophilia of the Umbria Region in the period 2011-2022.

Author

Marano G, Arcieri R, Rocchi RE, Annunziata A, Cutillo M, Bucaneve G, Da Cas R, and Rossi M

Subjects
Humans, Male, Retrospective Studies, Adult, Cross-Sectional Studies, Female, Middle Aged, Italy epidemiology, Young Adult, Aged, Depression epidemiology, Depression drug therapy, Adolescent, Comorbidity, Hemophilia A drug therapy, Hemophilia A epidemiology, Hemophilia A complications, Antipsychotic Agents therapeutic use, Antidepressive Agents therapeutic use
Abstract

Introduction: Chronic diseases, such as hemophilia, can evoke psychological sequelae and be associated with a higher risk of mental health disorders. The utilization of antidepressant and antipsychotic drugs in subjects with hemophilia is not completely understood and few data are available., Objectives: The aim of this analysis is to describe use of antidepressant and antipsychotic drugs in subjects with hemophilia of the Umbria Region in the period 2011-2022., Methods: A descriptive, cross-sectional, and retrospective analysis based on data on filled prescriptions for antidepressants and antipsychotics has been carried out. The overall and annual prevalence of drugs use and consumption were calculated based on pharmaceutical prescriptions charged to the National Health Service in subjects with hemophilia and matched controls from general population., Results: In the study period 170 subjects with hemophilia were identified; about 80% were male. About 20% and 8.2% received antidepressants and antipsychotics, respectively. A higher percentage of users and consumption were found in subjects with hemophilia compared to matched controls, although no statistically significant differences were observed., Conclusions: Our analysis suggests that depression and psychosis are important comorbidities in subjects with hemophilia. Further larger studies are needed in order to confirm these data and better define the burden of mental health disorders in subjects with hemophilia.

Published
2024
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42. Reduced mortality from KPC-K.pneumoniae bloodstream infection in high-risk patients with hematological malignancies colonized by KPC-K.pneumoniae.

Author

Micozzi A, Gentile G, Santilli S, Minotti C, Capria S, Moleti ML, Barberi W, Cartoni C, Trisolini SM, Testi AM, Iori AP, Bucaneve G, and Foà R

Subjects
Bacterial Proteins, Humans, Risk Factors, beta-Lactamases genetics, Bacteremia drug therapy, Hematologic Neoplasms complications, Klebsiella Infections
Abstract

Background: KPC-K.pneumoniae bloodstream infection (KPC-KpBSI) mortality rate in patients with hematological malignancies is reported about 60%. The initial treatment active against KPC-K.pneumoniae is crucial for survival and KPC-K.pneumoniae rectal colonization usually precedes KPC-KpBSI. We evaluated the impact on KPC-KpBSI mortality of the preemptive use of antibiotics active against KPC-K.pneumoniae, as opposed to inactive or standard empiric antibiotics, for the empiric treatment of febrile neutropenia episodes in patients with hematological malignancy identified as KPC-K.pneumoniae intestinal carriers., Methods: We compared the outcomes of KPC-KpBSIs occurring in high-risk hematological patients known to be colonized with KPC-K.pneumoniae, during two time periods: March2012-December2013 (Period 1, initial approach to KPC-K.pneumoniae spread) and January2017-October2018 (Period 2, full application of the preemptive strategy). The relative importance of the various prognostic factors that could influence death rates were assessed by forward stepwise logistic regression models., Results: KPC-KpBSI-related mortality in hematological patients identified as KPC-K.pneumoniae carriers dropped from 50% in Period 1 to 6% in Period 2 (p < 0.01), from 58 to 9% in acute myeloid leukemia carriers(p < 0.01). KPC-KpBSIs developed in patients identified as KPC-K.pneumoniae carriers were initially treated with active therapy in 56% and 100% of cases in Period 1 and Period 2, respectively (p < 0.01), in particular with an active antibiotic combination in 39 and 94% of cases, respectively(p < 0.01). The 61% of KPC-KpBSI observed in Period 1 developed during inactive systemic antibiotic treatment (none in Period 2, p < 0.01), fatal in the 73% of cases. Overall, KPC-KpBSI-related mortality was 88% with no initial active treatment, 11.5% with at least one initial active antibiotic (p < 0.01), 9% with initial active combination. Only the initial active treatment resulted independently associated with survival., Conclusions: In high-risk hematological patients colonized by KPC-K.pneumoniae, the empiric treatment of febrile neutropenia active against KPC-K.pneumoniae reduced KPC-KpBSI-related mortality to 6% and prevented fatal KPC-KpBSI occurrence during inactive systemic antibiotic treatment., (© 2021. The Author(s).)

Published
2021
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43. QuantiFERON-TB and tuberculin skin test in patients with active tuberculosis: the experience of a single medium-sized Italian University Hospital.

Author

Pasticci MB, Papalini C, Murgia N, Papili R, Bucaneve G, Malincarne L, Bozza S, Francisci D, and Cenci E

Subjects
Emigrants and Immigrants, Humans, Incidence, Italy, Mycobacterium tuberculosis, Latent Tuberculosis epidemiology, Tuberculin Test methods
Abstract

Interferon-γ releasing assays (IGRAs) are currently widely employed in the initial work up of Mycobacterium tuberculosis infection, as well as in suspected tuberculosis (TB). These assays are commonly utilized over the Tuberculin Skin Test (TST) in high resource and low TB burden settings, despite the unclear benefits shown in such contexts. The debate on the use of TST and IGRAs is of current interest also in Italy due to the increasing presence of immigrants from countries with a high incidence of TB and the rising attention of health care institutions to economic costs. The aim of this study was to compare QuantiFERON-TB (QFT) and TST results in active TB. We evaluated QFT results and TST reactions from 245 consecutive patients having both tests, registered among 411 patients admitted for TB at the Infectious Disease Clinic, Department of Medicine of the University of Perugia (Italy). We compared the rates of positive QFT and TST tests and noted no statistically significant differences overall or in relation to age, gender, HIV status and TB localization. Among foreign-born patients with confirmed TB, we observed a lower rate of positive TST results. The results of our study indicated that both QFT and TST can be used in the work up of TB having special attention when evaluating foreign-born patients.

Published
2021

44. Carbapenem-resistant Klebsiella pneumoniae in high-risk haematological patients: factors favouring spread, risk factors and outcome of carbapenem-resistant Klebsiella pneumoniae bacteremias.

Author

Micozzi A, Gentile G, Minotti C, Cartoni C, Capria S, Ballarò D, Santilli S, Pacetti E, Grammatico S, Bucaneve G, and Foà R

Subjects
Adult, Aged, Bacteremia drug therapy, Bacteremia epidemiology, Bacteremia mortality, Community-Acquired Infections drug therapy, Community-Acquired Infections epidemiology, Community-Acquired Infections prevention & control, Drug Resistance, Bacterial, Female, Hematologic Neoplasms drug therapy, Hematologic Neoplasms microbiology, Hospitals, Teaching, Humans, Infection Control methods, Italy epidemiology, Klebsiella Infections epidemiology, Klebsiella Infections mortality, Klebsiella pneumoniae drug effects, Male, Middle Aged, Retrospective Studies, Risk Factors, Treatment Outcome, Anti-Bacterial Agents therapeutic use, Bacteremia microbiology, Carbapenems therapeutic use, Hematologic Neoplasms complications, Klebsiella Infections drug therapy
Abstract

Background: Carbapenem-resistant Klebsiella pneumoniae (CRKP) spread and infections in patients with haematological malignancies are a serious concern especially in endemic areas. Treatment failures and delay in appropriate therapy for CRKP infections are frequent and the mortality rate associated with CRKP bacteremia in neutropenic haematological patients is reported about 60%., Methods: Haematological patients harboring CRKP hospitalized between February 2012 and May 2013 in an Italian Teaching hospital were examined. Conditions favouring CRKP spread in a haematological unit, risk factors for bacteremia in CRKP-carriers and for CRKP bacteremia-related death were evaluated in this observational retrospective study., Results: CRKP was isolated in 22 patients, 14 (64%) had bacteremia. Control measures implementation, particularly the weekly rectal screening for CRKP performed in all hospitalized patients and contact precautions for CRKP-carriers and newly admitted patients until proved CRKP-negative, reduced significantly the CRKP spread (14 new carriers identified of 131 screened patients vs 5 of 242 after the intervention, p = 0.001). Fifty-eight percent of carriers developed CRKP bacteremia, and acute myeloid leukemia (AML) resulted independently associated with the bacteremia occurrence (p = 0.02). CRKP bacteremias developed mainly during neutropenia (86%) and in CRKP-carriers (79%). CRKP bacteremias were breakthrough in 10 cases (71%). Ten of 14 patient with CRKP bacteremias died (71%) and all had AML. The 70% of fatal bacteremias occurred in patients not yet recognized as CRKP-carriers and 80% were breakthrough. Initial adequate antibiotic therapy resulted the only independent factor able to protect against death (p = 0.02)., Conclusions: The identification of CRKP-carriers is confirmed critical to prevent CRKP spread. AML patients colonized by CRKP resulted at high risk of CRKP-bacteremia and poor outcome and the adequacy of the initial antibiotic therapy may be effective to improve survival. To limit the increase of resistance, the extensive use of antibiotics active against CRKP should be avoided, but in the setting of high CRKP pressure and high-risk CRKP-colonized haematological patients, timely empiric antibiotic combinations active against CRKP could be suggested as treatment of febrile neutropenia.

Published
2017
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45. Reply to J.H. Joshi.

Author

Micozzi A, Bucaneve G, and Gentile G

Subjects
Female, Humans, Male, Anti-Bacterial Agents administration & dosage, Chemotherapy-Induced Febrile Neutropenia drug therapy, Minocycline analogs & derivatives, Penicillanic Acid analogs & derivatives
Published
2014
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46. Results of a multicenter, controlled, randomized clinical trial evaluating the combination of piperacillin/tazobactam and tigecycline in high-risk hematologic patients with cancer with febrile neutropenia.

Author

Bucaneve G, Micozzi A, Picardi M, Ballanti S, Cascavilla N, Salutari P, Specchia G, Fanci R, Luppi M, Cudillo L, Cantaffa R, Milone G, Bocchia M, Martinelli G, Offidani M, Chierichini A, Fabbiano F, Quarta G, Primon V, Martino B, Manna A, Zuffa E, Ferrari A, Gentile G, Foà R, and Del Favero A

Subjects
Adolescent, Adult, Aged, Antineoplastic Agents adverse effects, Bacteremia drug therapy, Bacteremia etiology, Bacteremia mortality, Chemotherapy-Induced Febrile Neutropenia mortality, Drug Combinations, Female, Hematologic Neoplasms drug therapy, Humans, Male, Middle Aged, Minocycline administration & dosage, Penicillanic Acid administration & dosage, Piperacillin administration & dosage, Piperacillin, Tazobactam Drug Combination, Risk Factors, Tigecycline, Young Adult, Anti-Bacterial Agents administration & dosage, Chemotherapy-Induced Febrile Neutropenia drug therapy, Minocycline analogs & derivatives, Penicillanic Acid analogs & derivatives
Abstract

Purpose: Empiric antibiotic monotherapy is considered the standard of treatment for febrile neutropenic patients with cancer, but this approach may be inadequate because of the increasing prevalence of infections caused by multidrug resistant (MDR) bacteria., Patients and Methods: In this multicenter, open-label, randomized, superiority trial, adult, febrile, high-risk neutropenic patients (FhrNPs) with hematologic malignancies were randomly assigned to receive piperacillin/tazobactam (4.5 g intravenously every 8 hours) with or without tigecycline (50 mg intravenously every 12 hours; loading dose 100 mg). The primary end point was resolution of febrile episode without modifications of the initial allocated treatment., Results: Three hundred ninety FhrNPs were enrolled (combination/monotherapy, 187/203) and were included in the intention-to-treat analysis (ITTA). The ITTA revealed a successful outcome in 67.9% v 44.3% of patients who had received combination therapy and monotherapy, respectively (127/187 v 90/203; absolute difference in risk (adr), 23.6%; 95% CI, 14% to 33%; P < .001). The combination regimen proved better than monotherapy in bacteremias (adr, 32.8%; 95% CI, 19% to 46%; P < .001) and in clinically documented infections (adr, 36%; 95% CI, 9% to 64%; P < .01). Mortality and number of adverse effects were limited and similar in the two groups., Conclusion: The combination of piperacillin/tazobactam and tigecycline is safe, well tolerated, and more effective than piperacillin/tazobactam alone in febrile, high-risk, neutropenic hematologic patients with cancer. In epidemiologic settings characterized by a high prevalence of infections because of MDR microorganisms, this combination could be considered as one of the first-line empiric antibiotic therapies.

Published
2014
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47. Antibiotic prophylaxis in neutropenic patients: new evidence, practical decisions.

Author

Leibovici L, Paul M, Cullen M, Bucaneve G, Gafter-Gvili A, Fraser A, and Kern WV

Subjects
Acute Disease, Antineoplastic Agents adverse effects, Bone Marrow Transplantation, Ciprofloxacin therapeutic use, Decision Making, Drug Resistance, Enterocolitis, Pseudomembranous epidemiology, Enterocolitis, Pseudomembranous prevention & control, Gram-Positive Bacterial Infections epidemiology, Gram-Positive Bacterial Infections prevention & control, Humans, Leukemia drug therapy, Levofloxacin, Lymphoma drug therapy, Neoplasms drug therapy, Neutropenia chemically induced, Ofloxacin therapeutic use, Antibiotic Prophylaxis methods, Neutropenia drug therapy
Abstract

New evidence shows that antibiotic prophylaxis in neutropenic patients reduces mortality, febrile episodes, and bacterial infections. For patients with acute leukemia or those who undergo bone marrow transplantation, prophylaxis with fluoroquinolones diminished the risk of death from any cause by 33% (95% confidence interval [95% CI], 2-54%). Thus, 55 patients who have acute leukemia or who undergo bone marrow transplantation must receive prophylaxis to prevent 1 death. In 4 studies that included patients with solid tumors or lymphoma, prophylaxis reduced the rate of death during the first month (relative risk, 0.51; 95% CI, 0.27-0.97), and 82 patients had to receive prophylaxis to prevent 1 death. The main argument brought against prophylaxis is the induction of resistance. Patients who received prophylaxis did not experience more infections caused by resistant strains than patients in the control group. The recent GIMEMA study was conducted in a population with a nearly 50% resistance to fluoroquinolones in all pathogens and 20% resistance in gram-negative isolates, thus indicating that prophylaxis should be offered in settings with similar or less resistance. Prophylaxis with fluoroquinolones was efficacious in reducing infections caused by gram-positive bacteria. Patients who are treated for acute leukemia should be offered prophylaxis with ciprofloxacin or levofloxacin. Prophylaxis to cover the expected period of neutropenia may be considered for the first cycle of treatment in patients with solid tumors or lymphoma who regularly receive regimens that cause severe neutropenia. Excessive local levels of resistance to fluoroquinolones or high local incidence of infections caused by Clostridium difficile and related to fluoroquinolones should prompt a reconsideration of this policy., (2006 American Cancer Society)

Published
2006
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48. Prophylaxis and treatment of bacterial infections: do we need new strategies?

Author

Micozzi A and Bucaneve G

Subjects
Bacterial Infections etiology, Drug Therapy, Combination, Humans, Neutropenia complications, Neutropenia drug therapy, Bacterial Infections drug therapy, Hematologic Neoplasms complications, Premedication methods
Abstract

Bacterial infections in patients with hematologic malignancies still represent a severe and life-treating problem. Several observational studies during the last decade have revealed that neutropenic patients with fever are a heterogeneous population with various differences regarding response to initial therapy, development of serious complications and mortality. The role of neutropenia as main risk factor for infections in hematologic patients and the definition of different level of risk related to neutrophils count and duration of neutropenia have been extensively studied and different categories of patients based on the risk of infection, mostly the condition of neutropenia, have been clearly defined. The strategies on antimicrobial therapy and supportive care in hematologic patients need to be continuously assessed, in fact new conditions favouring the occurrence of infectious complications in patients with hematologic malignancies have progressively emerged. The use of oral prophylactic antibiotics in neutropenic cancer patients is still a matter of debate. Before 2005, several trials showed how the prevention of infection can be extremely important in this setting of patients but none was conclusive. In 2005 two meta-analysis and two large randomized clinical trials gave new evidence that antibacterial prophylaxis can reduce in neutropenic patients several important outcomes including mortality. The use of the empiric antibacterial therapy represents the cornerstone of the antimicrobial strategies in the febrile neutropenic patients leading, over the span of 20 years, to a dramatic decrease of deaths: Actually beta-lactam monotherapy is commonly used for the empiric treatment of febrile neutropenia. Recently, large randomized clinical trials and meta-analysis showed that the addition of an aminoglycoside and/or a glycopeptides results in a more favourable outcome only in selected severe infections. The use of antibiotics should be prudent and safe also in neutropenic hematologic patients to prevent emergence of microbial resistance, to save costs, to reduce toxicity. For this reasons, according to the evidence, antibacterial prophylaxis should be restricted to high risk hematologic patients and empiric parenteral antibiotic monotherapy should be recommended in case of febrile neutropenia limiting the use of amynoglicosides and glycopeptides. In the next future, a major effort should be made to state in hematologic patients new risk factors which could more accurately define subgroups for targeted anti-infective strategies.

Published
2005

49. Choice of empirical therapy and prophylaxis.

Author

Del Favero A, Bucaneve G, and Furno P

Subjects
Anti-Bacterial Agents administration & dosage, Anti-Bacterial Agents classification, Anti-Bacterial Agents pharmacology, Anti-Bacterial Agents therapeutic use, Anti-Infective Agents therapeutic use, Bacterial Infections complications, Bacterial Infections drug therapy, Bacterial Infections epidemiology, Bacterial Infections prevention & control, Drug Resistance, Multiple, Bacterial, Drug Therapy, Combination therapeutic use, Evidence-Based Medicine, Fever etiology, Humans, Immunocompromised Host, Neoplasms complications, Neoplasms drug therapy, Neutropenia chemically induced, Neutropenia complications, Randomized Controlled Trials as Topic, Risk Factors, Antibiotic Prophylaxis, Infection Control, Infections drug therapy
Published
2004
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50. Monotherapy or aminoglycoside-containing combinations for empirical antibiotic treatment of febrile neutropenic patients: a meta-analysis.

Author

Furno P, Bucaneve G, and Del Favero A

Subjects
Aminoglycosides administration & dosage, Bacteremia drug therapy, Bacteremia etiology, Drug Therapy, Combination, Fever etiology, Humans, Neoplasms complications, Neutropenia etiology, Odds Ratio, Randomized Controlled Trials as Topic, Treatment Outcome, Aminoglycosides therapeutic use, Anti-Bacterial Agents therapeutic use, Fever drug therapy, Neoplasms drug therapy, Neutropenia drug therapy
Abstract

We set out to compare the efficacy of antibiotic monotherapy with that of combination therapy including an aminoglycoside for empirical treatment of febrile neutropenic cancer patients. We did a meta-analysis of 29 randomised clinical trials pooling data from 4795 febrile episodes and a subset of 1029 bacteraemic episodes by both fixed and random effects models. Outcome measure was clinical failure of antibiotic treatment, defined as modification of the initially allocated regimen or death during treatment. In febrile episodes, the pooled odds ratio (OR) of clinical failure with monotherapy versus combination therapy was 0.88, with 95% CI from 0.78 to 0.99 by the fixed effects model, and 0.87 with 95% CI from 0.75 to 1.01 by the more conservative random effects model. For bacteraemic episodes, the pooled OR of failure with monotherapy was 0.70 (0.54 to 0.92) by the fixed effects model, and 0.72 (0.54 to 0.95) by the random effects model. We conclude that monotherapy has been as effective as aminoglycoside-containing combinations for empirical treatment of febrile neutropenia.

Published
2002
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