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

Mahidol University

Status and phase: Enrolling; Phase 4

Conditions: Colonization, Asymptomatic

Treatments: Drug: Neomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT05593601

SI-CEU-02-2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Neomycin

Active Comparator group

Description:

Patients enrolled in this arm will receive Neomycin.

Treatment:

Drug: Neomycin

Non neomycin

No Intervention group

Description:

Patients enrolled in this arm will not receive any interventions.