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

Phase 4

Recruiting

• Conditions: Colonization, Asymptomatic
• Interventions: Drug: Neomycin

• Registration Number: NCT05593601
• Lead Sponsor: Mahidol University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-10-17
• Study First Submitted QC: 2022-10-20
• Study First Posted: 2022-10-25
• Status Verified: 2022-11
• Study Start: 2022-11-24
• Last Update Submitted: 2022-11-24
• Last Update Posted: 2022-11-30
• Primary Completion: 2023-12-31
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neomycin	Neomycin	Patients enrolled in this arm will receive Neomycin.

Primary Outcome Measures

Name	Time	Method
Number of patients with microbiological eradication at 2 weeks after neomycin administration	2 weeks	Microbiological eradication is defined as the disappearance of CRE in hospitalized patients' faces at 2 weeks after neomycin administration

Secondary Outcome Measures

Name	Time	Method
Incidence of ์Neomycin toxicity (safety)	2 weeks	Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Number of CRE isolates susceptible to amikacin at 2 weeks after neomycin administration	2 weeks	Number of CRE isolates are susceptible to amikacin after at 2 weeks after neomycin administration according to the Clinical and Laboratory Standards Institute (CLSI) guideline.
Incidence of ์carbapenemases in isolated CRE	2 weeks	Number of carbapenemases in isolated CRE
Number of CRE isolates susceptible to neomycin at 2 weeks after neomycin administration	2 weeks	Number of CRE isolates are susceptible to neomycin at 2 weeks after neomycin administration according to the Clinical and Laboratory Standards Institute (CLSI) guideline.
Number of CRE isolates susceptible to gentamicin at 2 weeks after neomycin administration	2 weeks	Number of CRE isolates are susceptible to gentamicin at 2 weeks after neomycin administration according to the Clinical and Laboratory Standards Institute (CLSI) guideline.

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand