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Scientific article
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A 5-day course of oral antibiotics followed by faecal transplantation to eradicate carriage of multidrug-resistant Enterobacteriaceae: a randomized clinical trial

Published inClinical microbiology and infection, vol. 25, no. 7, p. 830-838
Publication date2019-07
First online date2019-01-04
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.

eng
Keywords
  • Carbapenemase
  • Colistin
  • Extended-spectrum β-lactamase
  • Faecal microbiota transplantation
  • Neomycin
  • Administration, Oral
  • Aged
  • Anti-Bacterial Agents / therapeutic use
  • Carbapenem-Resistant Enterobacteriaceae / drug effects
  • Carrier State / drug therapy
  • Carrier State / microbiology
  • Colistin / therapeutic use
  • Drug Administration Schedule
  • Drug Resistance, Multiple, Bacterial
  • Enterobacteriaceae Infections / drug therapy
  • Fecal Microbiota Transplantation
  • Feces / microbiology
  • Female
  • Humans
  • Male
  • Middle Aged
  • Tertiary Care Centers
  • beta-Lactamases
Funding
  • European Commission - Resistance in Gram-Negative Organisms: Studying Intervention Strategies [282512]
Citation (ISO format)
HUTTNER, Benedikt et al. A 5-day course of oral antibiotics followed by faecal transplantation to eradicate carriage of multidrug-resistant <i>Enterobacteriaceae</i>: a randomized clinical trial. In: Clinical microbiology and infection, 2019, vol. 25, n° 7, p. 830–838. doi: 10.1016/j.cmi.2018.12.009
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Article (Published version)
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Identifiers
ISSN of the journal1198-743X
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