Objectives: Intestinal carriage with extended spectrum beta-lactamase (ESBL-E) and carbapenemase-producing Enterobacteriaceae (CPE) can persist for months. We aimed to evaluate whether oral antibiotics followed by faecal microbiota transplantation (FMT) can eradicate intestinal carriage with ESBL-E/CPE.

Methods: Randomized, open-label, superiority trial in four tertiary care centres (Geneva [G], Paris [P], Utrecht [U], Tel Aviv [T]). Non-immunocompromised adult patients were randomized 1:1 to either no intervention [control] or a 5-day course of oral antibiotics (colistin sulphate 2 M IU 4x/day; neomycin sulphate 500mg 4x/day) followed by frozen FMT obtained from unrelated healthy donors. The primary outcome was detectable intestinal carriage of ESBL-E/CPE by stool culture 35-48 days after randomization (V4). ClinicalTrials.gov NCT02472600. The trial was funded by the European Commission (FP7).Results: 39 patients [G=14; P=16; U=7; T=2] colonized by ESBL-E (n=36) and/or CPE (n=11) were enrolled between 02/2016 and 06/2017. In the intention to treat analysis 9/22 (41%) patients assigned to the intervention arm were negative for ESBL-E/CPE at V4 (1/22 not receiving the intervention imputed as positive) while in the control arm 5/17 (29%) patients were negative (1 lost to follow-up imputed as negative) resulting in an OR for decolonization success of 1.7 [95%CI 0.4-6.4]. Study drugs were overall well tolerated but 3 patients in the intervention group prematurely stopped the study antibiotics because of diarrhoea (all received FMT).

Conclusions: Non-absorbable antibiotics followed by FMT slightly decreased ESBL/CPE carriage compared to controls; this difference was not statistically significant, potentially due to early trial-termination. Further clinical investigations seem warranted.

voor volledig artikel klik hier , gepubliceerd in clinical microbiologi and infection 

Auteurs: Benedikt D. Huttner, MD1,2,3; Victoire de Lastours, MD4,5; Marjan Wassenberg, MD6; Nitsan Maharshak, MD7; Anne Mauris8, Tatiana Galperine, MD1; Veronica Zanichelli, MD1; Nathalie Kapel, PharmD,9; Agnes Bellanger, PharmD10, Flaminia Olearo, MD1; Xavier Duval, MD11; Laurence Armand, PhD12; Yehuda Carmeli, MD13; Marc Bonten, MD2,14; Bruno Fantin, MD, PhD4,5; Stephan Harbarth, MD1,2,3 for the R-Gnosis WP3 study group

1Infection Control Program and WHO Collaborating Center, Geneva University Hospitals, Geneva, Switzerland
2Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland
3Faculty of medicine, University of Geneva, Geneva, Switzerland
4Division of Internal Medicine, Hôpital Beaujon, APHP, Clichy, France
5IAME Research Group, UMR 1137, INSERM and University Paris Diderot, Paris, France
6Department of Medical Microbiology, University Medical Center, Utrecht, The Netherlands
7Department of Gastroenterology and Liver Diseases, Tel-Aviv Medical Center, Affiliated to the Sackler Faculty of Medicine, Tel Aviv University,Tel Aviv, Israel
8Department of Genetics and Laboratory Medicine, Geneva University Hospitals (HUG), Geneva, Switzerland
9Department of Functional Coprology, APHP, Pitié-Salpêtrière Hospital, Paris, France
10Department of Pharmacy, APHP, Pitié-Salpêtrière Hospital, Paris, France
11Inserm CIC-1425, APHP, Hôpital Universitaire Bichat; Inserm UMR-1137 IAME; Université Paris Diderot, Paris 7, UFR de Médecine-Bichat, Paris, France
12Department of Medical Microbiology, APHP, Bichat-Claude-Bernard Hospital, Paris, France
13Department of Epidemiology, Tel Aviv Medical Center, Tel Aviv, Israel, affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
14Julius Center for Health Sciences and Primary Care, UMC Utrecht

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