Decolonization of Carbapenem-resistant Enterobacterales (CRE) in Patients With Faecal Carriage of CRE With Neomycin

Last updated: November 24, 2022
Sponsor: Mahidol University
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05593601
SI-CEU-02-2022
  • Ages 18-95
  • All Genders

Study Summary

Rates of antimicrobial resistance are increasing worldwide. There is increasing evidence that physiological gut microbiota is a large reservoir of antibiotic-resistance genes. Healthy gut microbiota is known to prevent the colonization of the gastrointestinal tract by pathogens, the so-called mechanism of colonization resistance, but this protective mechanism can be altered by therapies that impair gut microbiota, including antibiotics with consequent colonization of gut pathogens, including carbapenem-resistant Enterobacterales (CRE). CRE carriers represent an epidemiological threat to other hospitalized patients and to the whole community, but are also at risk of developing clinical consequences of this colonization, including bloodstream infections from these pathogens. Neomycin has shown high efficacy in the eradication of CRE invitro. Neomycin has also been approved to treat hepatic coma by eradicating bacterial in gastrointestinal tract. Therefore, this evidence suggests that this procedure could be useful in eradicating CRE.

However, current evidence is mostly limited.

The aim of this study is to investigate the efficacy of Neomycin, compared with no intervention in eradicating gut colonization from CRE.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient aged >18 years
  • Hospitalized in medical wards
  • Presence of CRE in stool/rectal swab without symptom from active surveillance of CRE
  • Sign informed consent to participate the study

Exclusion

Exclusion Criteria:

  • CRE infected patients
  • Receiving anti-CRE antibiotics
  • Known allergy to neomycin or other aminoglycosides
  • Receiving Cidofovir, Colistin methate sodium, foscarnet , furosemide, digoxin
  • eGFR (estimated Glomerular Filtration Rate) < 30 ml/min/1.73 m2
  • Had gastro-intestinal tract diseases
  • Pregnancy or breast-feeding

Study Design

Total Participants: 60
Study Start date:
November 24, 2022
Estimated Completion Date:
March 31, 2024

Study Description

The investigators will randomize patients colonized by CRE (diagnosed by rectal swab) to Neomycin by stratified randomization according to type of CRE species (E.coli or non-E.coli). Then, patients will be followed up, rectal swabs will be repeated, and stool samples for culture and will be collected, up to 14 days after Neomycin.

Connect with a study center

  • Faculty of Medicine Siriraj Hospital, Mahidol University

    Bangkok, 10700
    Thailand

    Active - Recruiting

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