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634 results on '"Glotz, D"'

1. Utility of anaerobic bottles for the diagnosis of bloodstream infections

Author

Lafaurie, M, d’Anglejan, E, Donay, JL, Glotz, D, Sarfati, E, Mimoun, M, Legrand, M, Oksenhendler, E, Bagot, M, Valade, S, Bercot, B, and Molina, JM

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Sepsis, Infectious Diseases, Hematology, Adult, Aged, Aged, 80 and over, Anti-Bacterial Agents, Bacteremia, Bacteria, Aerobic, Bacteria, Anaerobic, Blood Culture, Burns, Female, Humans, Male, Middle Aged, Neutropenia, Retrospective Studies, Tertiary Care Centers, Anaerobic, Blood culture, Microbiology, Medical Microbiology, Clinical sciences, Medical microbiology, Public health
Abstract

BACKGROUND:Obligate anaerobes usually account for less than 10% of bacteria recovered from blood cultures (BC). The relevance of routine use of the anaerobic bottle is under debate. The aim of this study was to evaluate the utility of anaerobic bottles for the diagnosis of bloodstream infections (BSI). METHODS:We conducted a 6-month, retrospective, monocentric study in a tertiary hospital. All positive BC were grouped into a single episode of bacteremia when drawn within 7 consecutive days. Bacteremia were classified into contaminants and BSI. Charts of patients with BSI due to obligate anaerobes were studied. RESULTS:A total of 19,739 blood cultures were collected, 2341 of which (11.9%) were positive. Anaerobic bottles were positive in 1528 (65.3%) of all positive BC but were positive alone (aerobic bottles negative) in 369 (15.8%). Overall 1081 episodes of bacteremia were identified, of which 209 (19.3%) had positive anaerobic bottles alone. The majority 126/209 (60.3%) were contaminants and 83 (39.7%) were BSI. BSI due to facultative anaerobes, obligate aerobes and obligate anaerobes were identified in 67 (80.7%), 3 (3.6%) and 13 (15.7%) of these 83 episodes, respectively. BSI due to obligate anaerobic bacteria were reported in 9 patients with gastro-intestinal disease, in 3 with febrile neutropenia and in 1 burned patient. CONCLUSIONS:Anaerobic bottles contributed to the diagnosis of a significant number of episodes of bacteremia. Isolated bacteria were mostly contaminants and non-obligate anaerobic pathogens. Rare BSI due to obligate anaerobes were reported mainly in patients with gastro-intestinal disorders and during febrile neutropenia.

Published
2020

2. The Banff 2015 Kidney Meeting Report: Current Challenges in Rejection Classification and Prospects for Adopting Molecular Pathology

Author

Loupy, A, Haas, M, Solez, K, Racusen, L, Glotz, D, Seron, D, Nankivell, BJ, Colvin, RB, Afrouzian, M, Akalin, E, Alachkar, N, Bagnasco, S, Becker, JU, Cornell, L, Drachenberg, C, Dragun, D, de Kort, H, Gibson, IW, Kraus, ES, Lefaucheur, C, Legendre, C, Liapis, H, Muthukumar, T, Nickeleit, V, Orandi, B, Park, W, Rabant, M, Randhawa, P, Reed, EF, Roufosse, C, Seshan, SV, Sis, B, Singh, HK, Schinstock, C, Tambur, A, Zeevi, A, and Mengel, M

Subjects
Organ Transplantation, Clinical Research, Transplantation, Detection, screening and diagnosis, 4.1 Discovery and preclinical testing of markers and technologies, Renal and urogenital, Arteritis, Complement C4b, Graft Rejection, Humans, Isoantibodies, Kidney Transplantation, Peptide Fragments, Research Report, clinical research, practice, translational research, science, kidney transplantation, nephrology, pathology, histopathology, organ transplantation in general, rejection, rejection: antibody-mediated, rejection: subclinical, rejection: T cell mediated, clinical research/practice, kidney transplantation/nephrology, pathology/histopathology, translational research/science, Medical and Health Sciences, Surgery
Abstract

The XIII Banff meeting, held in conjunction the Canadian Society of Transplantation in Vancouver, Canada, reviewed the clinical impact of updates of C4d-negative antibody-mediated rejection (ABMR) from the 2013 meeting, reports from active Banff Working Groups, the relationships of donor-specific antibody tests (anti-HLA and non-HLA) with transplant histopathology, and questions of molecular transplant diagnostics. The use of transcriptome gene sets, their resultant diagnostic classifiers, or common key genes to supplement the diagnosis and classification of rejection requires further consensus agreement and validation in biopsies. Newly introduced concepts include the i-IFTA score, comprising inflammation within areas of fibrosis and atrophy and acceptance of transplant arteriolopathy within the descriptions of chronic active T cell-mediated rejection (TCMR) or chronic ABMR. The pattern of mixed TCMR and ABMR was increasingly recognized. This report also includes improved definitions of TCMR and ABMR in pancreas transplants with specification of vascular lesions and prospects for defining a vascularized composite allograft rejection classification. The goal of the Banff process is ongoing integration of advances in histologic, serologic, and molecular diagnostic techniques to produce a consensus-based reporting system that offers precise composite scores, accurate routine diagnostics, and applicability to next-generation clinical trials.

Published
2017

8. Banff 2013 Meeting Report: Inclusion of C4d-Negative Antibody-Mediated Rejection and Antibody-Associated Arterial Lesions

Author

Haas, M., Sis, B., Racusen, L.C., Solez, K., Glotz, D., Colvin, R.B., Castro, M.C.R., David, D.S.R., David-Neto, E., Bagnasco, S.M., Cendales, L.C., Cornell, L.D., Demetris, A.J., Drachenberg, C.B., Farver, C.F., Farris, A.B., III, Gibson, I.W., Kraus, E., Liapis, H., Loupy, A., Nickeleit, V., Randhawa, P., Rodriguez, E.R., Rush, D., Smith, R.N., Tan, C.D., Wallace, W.D., and Mengel, M.

Published
2014
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10. The Banff 2017 Kidney Meeting Report: Revised diagnostic criteria for chronic active T cell–mediated rejection, antibody‐mediated rejection, and prospects for integrative endpoints for next‐generation clinical trials

Author

Haas, M., Loupy, A., Lefaucheur, C., Roufosse, C., Glotz, D., Seron, D., Nankivell, B. J., Halloran, P. F., Colvin, R. B., Akalin, Enver, Alachkar, N., Bagnasco, S., Bouatou, Y., Becker, J. U., Cornell, L. D., van Huyen, J. P. Duong, Gibson, I. W., Kraus, Edward S., Mannon, R. B., Naesens, M., Nickeleit, V., Nickerson, P., Segev, D. L., Singh, H. K., Stegall, M., Randhawa, P., Racusen, L., Solez, K., and Mengel, M.

Published
2018
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12. Proposed Definitions of Antibody-Mediated Rejection for Use as a Clinical Trial Endpoint in Kidney Transplantation

Author

Roufosse, C., Becker, J.U., Rabant, M., Seron, D., Bellini, M.I., Böhmig, G.A., Budde, K., Diekmann, F., Glotz, D., Hilbrands, L.B., Loupy, A., Oberbauer, R., Pengel, L., Schneeberger, S., Naesens, M., Roufosse, C., Becker, J.U., Rabant, M., Seron, D., Bellini, M.I., Böhmig, G.A., Budde, K., Diekmann, F., Glotz, D., Hilbrands, L.B., Loupy, A., Oberbauer, R., Pengel, L., Schneeberger, S., and Naesens, M.

Abstract

Item does not contain fulltext, Antibody-mediated rejection (AMR) is caused by antibodies that recognize donor human leukocyte antigen (HLA) or other targets. As knowledge of AMR pathophysiology has increased, a combination of factors is necessary to confirm the diagnosis and phenotype. However, frequent modifications to the AMR definition have made it difficult to compare data and evaluate associations between AMR and graft outcome. The present paper was developed following a Broad Scientific Advice request from the European Society for Organ Transplantation (ESOT) to the European Medicines Agency (EMA), which explored whether updating guidelines on clinical trial endpoints would encourage innovations in kidney transplantation research. ESOT considers that an AMR diagnosis must be based on a combination of histopathological factors and presence of donor-specific HLA antibodies in the recipient. Evidence for associations between individual features of AMR and impaired graft outcome is noted for microvascular inflammation scores ≥2 and glomerular basement membrane splitting of >10% of the entire tuft in the most severely affected glomerulus. Together, these should form the basis for AMR-related endpoints in clinical trials of kidney transplantation, although modifications and restrictions to the Banff diagnostic definition of AMR are proposed for this purpose. The EMA provided recommendations based on this Broad Scientific Advice request in December 2020; further discussion, and consensus on the restricted definition of the AMR endpoint, is required.

Published
2022

13. Surrogate Endpoints for Late Kidney Transplantation Failure

Author

Naesens, M., Budde, K., Hilbrands, L.B., Oberbauer, R., Bellini, M.I., Glotz, D., Grinyó, J., Heemann, U., Jochmans, I., Pengel, L., Reinders, M., Schneeberger, S., Loupy, A., Naesens, M., Budde, K., Hilbrands, L.B., Oberbauer, R., Bellini, M.I., Glotz, D., Grinyó, J., Heemann, U., Jochmans, I., Pengel, L., Reinders, M., Schneeberger, S., and Loupy, A.

Abstract

Contains fulltext : 252106.pdf (Publisher’s version ) (Open Access), In kidney transplant recipients, late graft failure is often multifactorial. In addition, primary endpoints in kidney transplantation studies seek to demonstrate the short-term efficacy and safety of clinical interventions. Although such endpoints might demonstrate short-term improvement in specific aspects of graft function or incidence of rejection, such findings do not automatically translate into meaningful long-term graft survival benefits. Combining many factors into a well-validated model is therefore more likely to predict long-term outcome and better reflect the complexity of late graft failure than using single endpoints. If conditional marketing authorization could be considered for therapies that aim to improve long-term outcomes following kidney transplantation, then the surrogate endpoint for graft failure in clinical trial settings needs clearer definition. This Consensus Report considers the potential benefits and drawbacks of several candidate surrogate endpoints (including estimated glomerular filtration rate, proteinuria, histological lesions, and donor-specific anti-human leukocyte antigen antibodies) and composite scoring systems. The content was created from information prepared by a working group within the European Society for Organ Transplantation (ESOT). The group submitted a Broad Scientific Advice request to the European Medicines Agency (EMA), June 2020: the request focused on clinical trial design and endpoints in kidney transplantation. Following discussion and refinement, the EMA made final recommendations to ESOT in December 2020 regarding the potential to use surrogate endpoints in clinical studies that aim to improving late graft failure.

Published
2022

14. Rationale for Surrogate Endpoints and Conditional Marketing Authorization of New Therapies for Kidney Transplantation

Author

Naesens, M., Loupy, A., Hilbrands, L.B., Oberbauer, R., Bellini, M.I., Glotz, D., Grinyó, J., Heemann, U., Jochmans, I., Pengel, L., Reinders, M., Schneeberger, S., Budde, K., Naesens, M., Loupy, A., Hilbrands, L.B., Oberbauer, R., Bellini, M.I., Glotz, D., Grinyó, J., Heemann, U., Jochmans, I., Pengel, L., Reinders, M., Schneeberger, S., and Budde, K.

Abstract

Contains fulltext : 252103.pdf (Publisher’s version ) (Open Access), Conditional marketing authorization (CMA) facilitates timely access to new drugs for illnesses with unmet clinical needs, such as late graft failure after kidney transplantation. Late graft failure remains a serious, burdensome, and life-threatening condition for recipients. This article has been developed from content prepared by members of a working group within the European Society for Organ Transplantation (ESOT) for a Broad Scientific Advice request, submitted by ESOT to the European Medicines Agency (EMA), and reviewed by the EMA in 2020. The article presents the rationale for using surrogate endpoints in clinical trials aiming at improving late graft failure rates, to enable novel kidney transplantation therapies to be considered for CMA and improve access to medicines. The paper also provides background data to illustrate the relationship between primary and surrogate endpoints. Developing surrogate endpoints and a CMA strategy could be particularly beneficial for studies where the use of primary endpoints would yield insufficient statistical power or insufficient indication of long-term benefit following transplantation.

Published
2022

15. Proposed Definitions of T Cell-Mediated Rejection and Tubulointerstitial Inflammation as Clinical Trial Endpoints in Kidney Transplantation

Author

Seron, D., Rabant, M., Becker, J.U., Roufosse, C., Bellini, M.I., Böhmig, G.A., Budde, K., Diekmann, F., Glotz, D., Hilbrands, L.B., Loupy, A., Oberbauer, R., Pengel, L., Schneeberger, S., Naesens, M., Seron, D., Rabant, M., Becker, J.U., Roufosse, C., Bellini, M.I., Böhmig, G.A., Budde, K., Diekmann, F., Glotz, D., Hilbrands, L.B., Loupy, A., Oberbauer, R., Pengel, L., Schneeberger, S., and Naesens, M.

Abstract

Contains fulltext : 252101.pdf (Publisher’s version ) (Open Access), The diagnosis of acute T cell-mediated rejection (aTCMR) after kidney transplantation has considerable relevance for research purposes. Its definition is primarily based on tubulointerstitial inflammation and has changed little over time; aTCMR is therefore a suitable parameter for longitudinal data comparisons. In addition, because aTCMR is managed with antirejection therapies that carry additional risks, anxieties, and costs, it is a clinically meaningful endpoint for studies. This paper reviews the history and classifications of TCMR and characterizes its potential role in clinical trials: a role that largely depends on the nature of the biopsy taken (indication vs protocol), the level of inflammation observed (e.g., borderline changes vs full TCMR), concomitant chronic lesions (chronic active TCMR), and the therapeutic intervention planned. There is ongoing variability-and ambiguity-in clinical monitoring and management of TCMR. More research, to investigate the clinical relevance of borderline changes (especially in protocol biopsies) and effective therapeutic strategies that improve graft survival rates with minimal patient morbidity, is urgently required. The present paper was developed from documentation produced by the European Society for Organ Transplantation (ESOT) as part of a Broad Scientific Advice request that ESOT submitted to the European Medicines Agency for discussion in 2020. This paper proposes to move toward refined definitions of aTCMR and borderline changes to be included as primary endpoints in clinical trials of kidney transplantation.

Published
2022

27. Banff 07 Classification of Renal Allograft Pathology: Updates and Future Directions

Author

Solez, K., Colvin, R.B., Racusen, L.C., Haas, M., Sis, B., Mengel, M., Halloran, P.F., Baldwin, W., Banfi, G., Collins, A.B., Cosio, F., David, D.S.R., Drachenberg, C., Einecke, G., Fogo, A.B., Gibson, I.W., Glotz, D., Iskandar, S.S., Kraus, E., Lerut, E., Mannon, R.B., Mihatsch, M., Nankivell, B.J., Nickeleit, V., Papadimitriou, J.C., Randhawa, P., Regele, H., Renaudin, K., Roberts, I., Seron, D., Smith, R.N., and Valente, M.

Published
2008
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