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16 results on '"Morris, Michele"'

1. A Retrospective, Observational Study of 12 Cases of Expanded-Access Customized Phage Therapy: Production, Characteristics, and Clinical Outcomes.

Author

Green, Sabrina, Clark, Justin, Santos, Haroldo, Weesner, Kyle, Salazar, Keiko, Aslam, Saima, Campbell, J, Blodget, Emily, Morris, Michele, Suh, Gina, Obeid, Karam, Silveira, Fernanda, Filippov, Andrey, Whiteson, Katrine, Trautner, Barbara, Terwilliger, Austen, Maresso, Anthony, and Doernberg, Sarah

Subjects
antibiotic resistance, microbiology, phage, phage therapy, Humans, Anti-Bacterial Agents, Bacteria, Bacterial Infections, Bacteriophages, Phage Therapy, Retrospective Studies
Abstract

BACKGROUND: Antimicrobial resistance (AMR) is undermining modern medicine, a problem compounded by bacterial adaptation to antibiotic pressures. Phages are viruses that infect bacteria. Their diversity and evolvability offer the prospect of their use as a therapeutic solution. Reported are outcomes of customized phage therapy for patients with difficult-to-treat antimicrobial resistant infections. METHODS: We retrospectively assessed 12 cases of customized phage therapy from a phage production center. Phages were screened, purified, sequenced, characterized, and Food and Drug Administration-approved via the IND (investigational new drug) compassionate-care route. Outcomes were assessed as favorable or unfavorable by microbiologic and clinical standards. Infections were device-related or systemic. Other experiences such as time to treatment, antibiotic synergy, and immune responses were recorded. RESULTS: Fifty requests for phage therapy were received. Customized phages were generated for 12 patients. After treatment, 42% (5/12) of cases showed bacterial eradication and 58% (7/12) showed clinical improvement, with two-thirds of all cases (66%) showing favorable responses. No major adverse reactions were observed. Antibiotic-phage synergy in vitro was observed in most cases. Immunological neutralization of phages was reported in 5 cases. Several cases were complicated by secondary infections. Complete characterization of the phages (morphology, genomics, and activity) and their production (methods, sterility, and endotoxin tests) are reported. CONCLUSIONS: Customized phage production and therapy was safe and yielded favorable clinical or microbiological outcomes in two-thirds of cases. A center or pipeline dedicated to tailoring the phages against a patients specific AMR bacterial infection may be a viable option where standard treatment has failed.

Published
2023

2. National Landscape of Human Immunodeficiency Virus-Positive Deceased Organ Donors in the United States.

Author

Werbel, William A, Brown, Diane M, Kusemiju, Oyinkansola T, Doby, Brianna L, Seaman, Shanti M, Redd, Andrew D, Eby, Yolanda, Fernandez, Reinaldo E, Desai, Niraj M, Miller, Jernelle, Bismut, Gilad A, Kirby, Charles S, Schmidt, Haley A, Clarke, William A, Seisa, Michael, Petropoulos, Christos J, Quinn, Thomas C, Florman, Sander S, Huprikar, Shirish, Rana, Meenakshi M, Friedman-Moraco, Rachel J, Mehta, Aneesh K, Stock, Peter G, Price, Jennifer C, Stosor, Valentina, Mehta, Shikha G, Gilbert, Alexander J, Elias, Nahel, Morris, Michele I, Mehta, Sapna A, Small, Catherine B, Haidar, Ghady, Malinis, Maricar, Husson, Jennifer S, Pereira, Marcus R, Gupta, Gaurav, Hand, Jonathan, Kirchner, Varvara A, Agarwal, Avinash, Aslam, Saima, Blumberg, Emily A, Wolfe, Cameron R, Myer, Kevin, Wood, R Patrick, Neidlinger, Nikole, Strell, Sara, Shuck, Marion, Wilkins, Harry, Wadsworth, Matthew, Motter, Jennifer D, Odim, Jonah, Segev, Dorry L, Durand, Christine M, Tobian, Aaron AR, Piquant, Dominque, Link, Katherine, Hemmersbach-Miller, Marion, Pearson, Thomas, Turgeon, Nicole, Lyon, G Marshall, Kitchens, William, Huckaby, Jeryl, Lasseter, A Francie, Elbein, Rivka, Roberson, April, Ferry, Elizabeth, Klock, Ethan, Cochran, Willa V, Morrison, Michelle, Rasmussen, Sarah, Bollinger, Juli, Sugarman, Jeremy, Smith, Angela R, Thomas, Margaret, Coakley, Margaret, Timpone, Joseph, Stucke, Alyssa, Haydel, Brandy, Dieter, Rebecca, Klein, Elizabeth J, Neumann, Henry, Gallon, Lorenzo, Goudy, Leah, Callegari, Michelle, Marrazzo, Ilise, Jackson, Towanda, Pruett, Timothy, Farnsworth, Mary, Locke, Jayme E, Mompoint-Williams, Darnell, Basinger, Katherine, Mekeel, Kristin, Nguyen, Phirum, Kwan, Joanne, Srisengfa, Tab, Chin-Hong, Peter, Rogers, Rodney, Simkins, Jacques, Munoz, Carlos, and Dunn, Ty

Subjects
Pediatric Research Initiative, HIV/AIDS, Infectious Diseases, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Infection, Good Health and Well Being, Anti-Retroviral Agents, HIV, HIV Infections, HIV Seropositivity, Humans, Integrases, Prospective Studies, Tissue Donors, United States, Viral Load, transplant, organ donation, drug resistance, HOPE in Action Investigators, Biological Sciences, Medical and Health Sciences, Microbiology
Abstract

BackgroundOrgan transplantation from donors with human immunodeficiency virus (HIV) to recipients with HIV (HIV D+/R+) presents risks of donor-derived infections. Understanding clinical, immunologic, and virologic characteristics of HIV-positive donors is critical for safety.MethodsWe performed a prospective study of donors with HIV-positive and HIV false-positive (FP) test results within the HIV Organ Policy Equity (HOPE) Act in Action studies of HIV D+/R+ transplantation (ClinicalTrials.gov NCT02602262, NCT03500315, and NCT03734393). We compared clinical characteristics in HIV-positive versus FP donors. We measured CD4 T cells, HIV viral load (VL), drug resistance mutations (DRMs), coreceptor tropism, and serum antiretroviral therapy (ART) detection, using mass spectrometry in HIV-positive donors.ResultsBetween March 2016 and March 2020, 92 donors (58 HIV positive, 34 FP), representing 98.9% of all US HOPE donors during this period, donated 177 organs (131 kidneys and 46 livers). Each year the number of donors increased. The prevalence of hepatitis B (16% vs 0%), syphilis (16% vs 0%), and cytomegalovirus (CMV; 91% vs 58%) was higher in HIV-positive versus FP donors; the prevalences of hepatitis C viremia were similar (2% vs 6%). Most HIV-positive donors (71%) had a known HIV diagnosis, of whom 90% were prescribed ART and 68% had a VL

Published
2022

3. How Clean Is the Linen at My Hospital? The Mucorales on Unclean Linen Discovery Study of Large United States Transplant and Cancer Centers

Author

Sundermann, Alexander J, Clancy, Cornelius J, Pasculle, A William, Liu, Guojun, Cumbie, Richard B, Driscoll, Eileen, Ayres, Ashley, Donahue, Lisa, Pergam, Steven A, Abbo, Lilian, Andes, David R, Chandrasekar, Pranatharthi, Galdys, Alison L, Hanson, Kimberly E, Marr, Kieren A, Mayer, Jeanmarie, Mehta, Seema, Morris, Michele I, Perfect, John, Revankar, Sanjay G, Smith, Becky, Swaminathan, Sankar, Thompson, George R, Varghese, Merin, Vazquez, Jose, Whimbey, Estella, Wingard, John R, and Nguyen, M Hong

Subjects
Cancer, Bedding and Linens, Disinfection, Equipment Contamination, Humans, Infection Control, Laundry Service, Hospital, Mucorales, Textiles, United States, Mucorales, Rhizopus, Syncephalastrum, healthcare linens, microbiologic surveillance, Biological Sciences, Medical and Health Sciences, Microbiology
Abstract

Mucormycosis outbreaks have been linked to contaminated linen. We performed fungal cultures on freshly-laundered linens at 15 transplant and cancer hospitals. At 33% of hospitals, the linens were visibly unclean. At 20%, Mucorales were recovered from >10% of linens. Studies are needed to understand the clinical significance of our findings.

Published
2019

5. Histoplasmosis After Solid Organ Transplant

Author

Assi, Maha, Martin, Stanley, Wheat, L. Joseph, Hage, Chadi, Freifeld, Alison, Avery, Robin, Baddley, John W., Vergidis, Paschalis, Miller, Rachel, Andes, David, Young, Jo-Anne H., Hammoud, Kassem, Huprikar, Shirish, McKinsey, David, Myint, Thein, Garcia-Diaz, Julia, Esguerra, Eden, Kwak, E. J., Morris, Michele, Mullane, Kathleen M., Prakash, Vidhya, Burdette, Steven D., Sandid, Mohammad, Dickter, Jana, Ostrander, Darin, Antoun, Smyrna Abou, and Kaul, Daniel R.

Published
2013
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6. Assessment of Cytomegalovirus-Specific Cell-Mediated Immunity for the Prediction of Cytomegalovirus Disease in High-Risk Solid-Organ Transplant Recipients: A Multicenter Cohort Study

Author

Manuel, Oriol, Husain, Shahid, Kumar, Deepali, Zayas, Carlos, Mawhorter, Steve, Levi, Marilyn E., Kalpoe, Jayant, Lisboa, Luiz, Ely, Leticia, Kaul, Daniel R., Schwartz, Brian S., Morris, Michele I., Ison, Michael G., Yen-Lieberman, Belinda, Sebastian, Anthony, Assi, Maha, and Humar, Atul

Published
2013
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7. Unrecognized Pretransplant and Donor-Derived Cryptococcal Disease in Organ Transplant Recipients

Author

Cryptococcal Collaborative Transplant Study Group, Sun, Hsin-Yun, Alexander, Barbara D., Lortholary, Olivier, Dromer, Francoise, Forrest, Graeme N., Lyon, G. Marshall, Somani, Jyoti, Gupta, Krishan L., del Busto, Ramon, Pruett, Timothy L., Sifri, Costi D., Limaye, Ajit P., John, George T., Klintmalm, Goran B., Pursell, Kenneth, Stosor, Valentina, Morris, Michele I., Dowdy, Lorraine A., Munoz, Patricia, Kalil, Andre C., Garcia-Diaz, Julia, Orloff, Susan L., House, Andrew A., Houston, Sally H., Wray, Dannah, Huprikar, Shirish, Johnson, Leonard B., Humar, Atul, Razonable, Raymund R., Fisher, Robert A., Husain, Shahid, Wagener, Marilyn M., and Singh, Nina

Published
2010

10. Unrecognized pretransplant and donor-derived cryptococcal disease in organ transplant recipients

Author

Sun, Hsin-Yun, Alexander, Barbara D., Lortholary, Olivier, Dromer, Francoise, Forrest, Graeme N., Lyon, G. Marshall, Somani, Jyoti, Gupta, Krishan L., del Busto, Ramon, Pruett, Timothy L., Sifri, Costi D., Limaye, Ajit P., John, George T., Klintmalm, Goran B., Pursell, Kenneth, Stosor, Valentina, Morris, Michele I., Dowdy, Lorraine A., Munoz, Patricia, Kalil, Andre C., Garcia-Diaz, Julia, Orloff, Susan L., House, Andrew A., Houston, Sally H., Wray, Dannah, Huprikar, Shirish, Johnson, Leonard B., Humar, Atul, Razonable, Raymund R., Fisher, Robert A., Husain, Shahid, Wagener, Marilyn M., and Singh, Nina

Subjects
Transplantation of organs, tissues, etc. -- Complications and side effects, Cryptococcal infections -- Patient outcomes, Cryptococcal infections -- Research, Cryptococcal infections -- Risk factors, Cryptococcus -- Research, Cryptococcus -- Health aspects, Health, Health care industry
Published
2010

11. Saddle Nose Deformity in an Immunosuppressed Patient

Author

Anjan, Shweta, primary, Morillas, Jose, additional, Simkins, Jacques, additional, Martinez, Octavio V, additional, Holung, Michelle, additional, Prado, Clara, additional, Jimenez, Antonio, additional, Lekakis, Lazaros J, additional, Komanduri, Krishna, additional, Morris, Michele I, additional, and Camargo, Jose F, additional

Published
2019
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12. How Clean Is the Linen at My Hospital? The Mucorales on Unclean Linen Discovery Study of Large United States Transplant and Cancer Centers

Author

Sundermann, Alexander J, primary, Clancy, Cornelius J, additional, Pasculle, A William, additional, Liu, Guojun, additional, Cumbie, Richard B, additional, Driscoll, Eileen, additional, Ayres, Ashley, additional, Donahue, Lisa, additional, Pergam, Steven A, additional, Abbo, Lilian, additional, Andes, David R, additional, Chandrasekar, Pranatharthi, additional, Galdys, Alison L, additional, Hanson, Kimberly E, additional, Marr, Kieren A, additional, Mayer, Jeanmarie, additional, Mehta, Seema, additional, Morris, Michele I, additional, Perfect, John, additional, Revankar, Sanjay G, additional, Smith, Becky, additional, Swaminathan, Sankar, additional, Thompson, George R, additional, Varghese, Merin, additional, Vazquez, Jose, additional, Whimbey, Estella, additional, Wingard, John R, additional, and Nguyen, M Hong, additional

Published
2018
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13. A Randomized, Placebo-controlled Trial of Fidaxomicin for Prophylaxis ofClostridium difficile–associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation

Author

Mullane, Kathleen M, primary, Winston, Drew J, additional, Nooka, Ajay, additional, Morris, Michele I, additional, Stiff, Patrick, additional, Dugan, Michael J, additional, Holland, Henry, additional, Gregg, Kevin, additional, Adachi, Javier A, additional, Pergam, Steven A, additional, Alexander, Barbara D, additional, Dubberke, Erik R, additional, Broyde, Natalya, additional, Gorbach, Sherwood L, additional, and Sears, Pamela S, additional

Published
2018
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14. Clinical research in the lay press: irresponsible journalism raises a huge dose of doubt

Author

Anaissie, Elias J., Segal, Brahm H., Graybill, John R., Arndt, Carola, Perfect, John R., Kleinberg, Michael, Pappas, Peter, Benjamin, Danny, Rubin, Robert, Aberg, Judith A., Adderson, Elisabeth E., Adler-Shohet, Felice C., Akan, Hamdi, Akova, Murat, Almyroudis, Nikolaos G., Alexander, Barbara D., Andes, David, Arrieta, Antonio, Baddley, John W., Barron, Michelle A., Belzberg, Howard, Boucher, Helen W., Boyce, Thomas G., Casadevall, Arturo, Chandrasekar, P.H., Cleary, John D., Cordonnier, Catherine, Cornely, Oliver A., Cuenca-Estrella, Manuel, Daly, Jennifer S., Daoura, Nicholas, Denning, David W., dePauw, Ben, Repentigny, Louis de, Dignani, Maria Cecilia, Dismukes, William E., Donnelly, J. Peter, Donowitz, Gerald R., Dupont, Bertrand, Drusano, George, Ellis, Michael, Espinel-Ingroff, Ana, Fishman, Jay A., Fleming, Rhonda, Forrest, Graeme, Ghannoum, Mahmoud, Goldman, Mitchell, Grazziutti, Monica, Greene, John N., Greenberg, Richard N., Gubbins, Paul O., Hadley, Susan, Herbrecht, Raoul, Hiemenz, John W., Hope, William, Hospenthal, Durane R., Husain, Shahid, Ito, James I., Jacobson, Robert M., Johnson, Melissa, Keating, Michael R., Kett, Daniel H., Knapp, Katherine, Kontoyiannis, Dimitrios P., Krcmery, Vladimir C., Larsen, Robert, Laverdiere, Michel, Ljungman, Per, Lortholary, O., Maertens, Johan, Marriott, Debbie, Mattiuzzi, Gloria, McGinnis, Michael R., Morris, Michele, Nucci, Marcio, Odds, Frank C., Pankey, George A., Patterson, Thomas, Pfaller, Mike, Razonable, Raymond R., Reboli, Annette C., Rinaldi, Michael G., Roberts, Glenn D., Tudela, Juan Luis Rodriguez, Rotstein, Coleman, Ruhnke, Markus, Schuster, Mindy, Shoham, Shmuel, Sia, Irene G., Siebel, Nita, Silviera, Fernanda, Singh, Nina, Sobel, Jack, Solomkin, Joseph S., Sorrell, Tania C., Steinbach, William J., Temesgen, Zelalem, Tortorano, AnnaMaria, Vartivarian, Shahe, VerWeij, Paul, Viscoli, Claudio, Viviani, Maria Anna, Walker, Randall C., Wheat, Joseph L., Wiley, Joseph, Williamson, Peter, Wingard, John R., Yu, Victor L., and Zaoutis, Theoklis

Subjects
Clinical trials -- Evaluation, Journalism, Medical -- Evaluation, Health, Health care industry
Published
2006

15. A Randomized, Placebo-controlled Trial of Fidaxomicin for Prophylaxis of Clostridium difficile–associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation.

Author

Mullane, Kathleen M, Winston, Drew J, Nooka, Ajay, Morris, Michele I, Stiff, Patrick, Dugan, Michael J, Holland, Henry, Gregg, Kevin, Adachi, Javier A, Pergam, Steven A, Alexander, Barbara D, Dubberke, Erik R, Broyde, Natalya, Gorbach, Sherwood L, and Sears, Pamela S

Subjects
ANTI-infective agents, DIAGNOSIS of diarrhea, AUTOGRAFTS, DIARRHEA, CLOSTRIDIUM diseases, DISEASES, DRUG side effects, HEMATOPOIETIC stem cell transplantation, HOMOGRAFTS, IMMUNOASSAY, MICROBIAL sensitivity tests, NEUTROPHILS, RANDOMIZED controlled trials, TREATMENT effectiveness, DISEASE incidence, BLIND experiment, ANTIBIOTIC prophylaxis, NUCLEIC acid amplification techniques, FIDAXOMICIN, DISEASE complications, ADULTS, DIAGNOSIS, PREVENTION
Abstract

Background Clostridium difficile –associated diarrhea (CDAD) is common during hematopoietic stem-cell transplantation (HSCT) and is associated with increased morbidity and mortality. We evaluated fidaxomicin for prevention of CDAD in HSCT patients. Methods In this double-blind study, subjects undergoing HSCT with fluoroquinolone prophylaxis stratified by transplant type (autologous/allogeneic) were randomized to once-daily oral fidaxomicin (200 mg) or a matching placebo. Dosing began within 2 days of starting conditioning or fluoroquinolone prophylaxis and continued until 7 days after neutrophil engraftment or completion of fluoroquinolone prophylaxis/clinically-indicated antimicrobials for up to 40 days. The primary endpoint was CDAD incidence through 30 days after study medication. The primary endpoint analysis counted confirmed CDAD, receipt of CDAD-effective medications (for any indication), and missing CDAD assessment (for any reason, including death) as failures; this composite analysis is referred to as "prophylaxis failure" to distinguish from the pre-specified sensitivity analysis, which counted only confirmed CDAD (by toxin immunoassay or nucleic acid amplification test) as failure. Results Of 611 subjects enrolled, 600 were treated and analyzed. Prophylaxis failure was similar in fidaxomicin and placebo recipients (28.6% vs 30.8%; difference 2.2% [-5.1, 9.5], P =.278). However, most failures were due to non-CDAD events. Confirmed CDAD was lower in fidaxomicin vs placebo recipients (4.3% vs 10.7%; difference 6.4% [2.2, 10.6], P =.0014). Drug-related adverse events occurred in 15.0% of fidaxomicin recipients and 20.0% of placebo recipients. Conclusions While no difference was demonstrated between arms in the primary analysis, results of the sensitivity analysis demonstrated that fidaxomicin significantly reduced the incidence of CDAD in HSCT recipients. Clinical Trials Registration NCT01691248 [ABSTRACT FROM AUTHOR]

Published
2019
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16. Unrecognized Pretransplant and Donor-Derived Cryptococcal Disease in Organ Transplant Recipients.

Author

Hsin-Yun Sun, Alexander, Barbara D., Lortholary, Olivier, Dromer, Francoise, Graeme N. Forrest, Lyon, G. Marshall, Somani, Jyoti, Gupta, Krishan L., del Busto, Ramon, Pruett, Timothy L., Sifri, Costi D., Limaye, Ajit P., John, George T., Klintmalm, Goran B., Pursell, Kenneth, Stosor, Valentina, Morris, Michele I., Dowdy, Lorraine A., Munoz, Patricia, and Kalil, Andre C.

Subjects
CRYPTOCOCCOSIS, LIVER transplantation, HEART transplantation, TRANSPLANTATION of organs, tissues, etc., ORGAN donors, HOMOGRAFTS, DISEASES
Abstract

Background. Cryptococcosis occurring ⩽30 days after transplantation is an unusual event, and its characteristics are not known. Methods. Patients included 175 solid-organ transplant (SOT) recipients with cryptococcosis in a multicenter cohort. Very early-onset and late-onset cryptococcosis were defined as disease occurring ⩽30 days or >30 days after transplantation, respectively. Results. Very early-onset disease developed in 9 (5%) of the 175 patients at a mean of 5.7 days after transplantation. Overall, 55.6% (5 of 9) of the patients with very early-onset disease versus 25.9% (43 of 166) of the patients with late-onset disease were liver transplant recipients (P = .05). Very early cases were more likely to present with disease at unusual locations, including transplanted allograft and surgical fossa/site infections (55.6% vs 7.2%; P < .001). Two very early cases with onset on day 1 after transplantation (in a liver transplant recipient with Cryptococcus isolated from the lung and a heart transplant recipient with fungemia) likely were the result of undetected pretransplant disease. An additional 5 cases involving the allograft or surgical sites were likely the result of donor-acquired infection. Conclusions. A subset of SOT recipients with cryptococcosis present very early after transplantation with disease that appears to occur preferentially in liver transplant recipients and involves unusual sites, such as the transplanted organ or the surgical site. These patients may have unrecognized pretransplant or donor-derived cryptococcosis. [ABSTRACT FROM AUTHOR]

Published
2010
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