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Clin Microbiol Infect. 2019 Jul;25(7):830-838. doi: 10.1016/j.cmi.2018.12.009. Epub 2019 Jan 4.

A 5-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 Programme and WHO Collaborating Centre, 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 Centre, Utrecht, the Netherlands.
4
Department of Gastroenterology and Liver Diseases, Tel-Aviv Medical Centre, Affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
5
Department of Genetics and Laboratory Medicine, Geneva University Hospitals, Geneva, Switzerland.
6
Infection Control Programme and WHO Collaborating Centre, 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, Paris, France; Inserm UMR-1137 IAME, Paris, France; Université Paris Diderot, Paris 7, UFR de Médecine-Bichat, Paris, France.
10
IAME Research Group, UMR 1137, INSERM and University Paris Diderot, Paris, France; Department of Medical Microbiology, APHP, Bichat-Claude-Bernard Hospital, Paris, France.
11
National Institute for Antibiotic Resistance and Infection Control, Tel Aviv Medical Center, and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
12
Department of Medical Microbiology, University Medical Centre, Utrecht, the Netherlands; Julius Centre for Health Sciences and Primary Care, UMC Utrecht, the Netherlands.
13
Infection Control Programme and WHO Collaborating Centre, Geneva University Hospitals, Geneva, Switzerland; Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland; Faculty of Medicine, University of Geneva, Geneva, Switzerland.
14
Utrecht, the Netherlands.
15
Paris, France.
16
Geneva, Switzerland.
17
Tel Aviv, Israel.

Abstract

OBJECTIVES:

Intestinal carriage with extended spectrum β-lactamase Enterobacteriaceae (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 × 106 IU 4×/day; neomycin sulphate 500 mg 4×/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.govNCT02472600. The trial was funded by the European Commission (FP7).

RESULTS:

Thirty-nine patients (G = 14; P = 16; U = 7; T = 2) colonized by ESBL-E (n = 36) and/or CPE (n = 11) were enrolled between February 2016 and June 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) whereas in the control arm 5/17 (29%) patients were negative (one 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 well tolerated overall but three 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-E/CPE carriage compared with controls; this difference was not statistically significant, potentially due to early trial termination. Further clinical investigations seem warranted.

KEYWORDS:

Carbapenemase; Colistin; Extended-spectrum β-lactamase; Faecal microbiota transplantation; Neomycin

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