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NCT05593601

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

Status unknown Phase 4 Last updated 30 November 2022
What this trial tests

Phase 4 trial testing Neomycin in Colonization, Asymptomatic in 60 participants. Status unknown.

Timeline
24 November 2022
Primary endpoint
31 December 2023
31 March 2024

Quick facts

Lead sponsorMahidol University
PhasePhase 4
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment60
Start date24 November 2022
Primary completion31 December 2023
Estimated completion31 March 2024
Sites1 location across Thailand

Drugs / interventions tested

Conditions studied

Sponsor

Mahidol University

Who can join

Adults 18 to 95, any sex, with Colonization, Asymptomatic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Efficacy and Safety of Oral Neomycin for the Decolonization of Carbapenem-Resistant <i>Enterobacterales</i>: An Open-Label Randomized Controlled Trial.
    Tancharoen L, Srisomnuek A, Tiengrim S, Thamthaweechok N, et al · · 2024 · PMID 39200081 · DOI 10.3390/antibiotics13080781

Verify or expand the search:

Other trials of Neomycin

Trials testing the same drug.

Other recruiting trials for Colonization, Asymptomatic

Currently open trials in the same condition.

Other Mahidol University trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing