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NCT05593601
Decolonization of Carbapenem-resistant Enterobacterales (CRE) in Patients With Faecal Carriage of CRE With Neomycin
Phase 4 trial testing Neomycin in Colonization, Asymptomatic in 60 participants. Status unknown.
31 December 2023
Quick facts
| Lead sponsor | Mahidol University |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 24 November 2022 |
| Primary completion | 31 December 2023 |
| Estimated completion | 31 March 2024 |
| Sites | 1 location across Thailand |
Drugs / interventions tested
- Neomycin (NEOMYCIN) — full drug profile →
Conditions studied
- Colonization, Asymptomatic — all drugs for Colonization, Asymptomatic →
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):
-
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:
- PubMed search for NCT05593601
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Colonization, Asymptomatic
Currently open trials in the same condition.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05593601 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mahidol University
- Last refreshed: 30 November 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05593601.
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