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

• Status: Not yet recruiting
• Trial end date: 2024-03-31
• Target enrollment: 0
• Participant gender: All

Summary

Rates of antimicrobial resistanceare 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 FMT, in eradicating gut colonization from CRE.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mahidol University
• Treatments: Neomycin

Criteria

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, Colistimethate sodium, Foscanet, Forosemide, Digoxin

• eGFR <30 ml/min/1.73 m2

• Had gastro-intestinal tract diseases

• Pregnancy or breast-feeding