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Clin Microbiol Infect. 2019 Jan 4. pii: S1198-743X(18)30796-1. doi: 10.1016/j.cmi.2018.12.009. [Epub ahead of print]

A five-day course of oral antibiotics followed by faecal transplantation to eradicate carriage of multidrug-resistant Enterobacteriaceae: A Randomized Clinical Trial.

Author information

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

Abstract

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.

KEYWORDS:

Faecal microbiota transplantation; carbapenemase; colistin; extended-spectrum beta-lactamase; neomycin

PMID:
30616014
DOI:
10.1016/j.cmi.2018.12.009
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