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

NCT05593601 | Unknown Phase 4 DMC

• 1 other identifier: SI-CEU-02-2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonization, Asymptomatic

Keywords

Neomycin; CRE; carbapenem-resistant Enterobacterales

Outcome Measures

Primary Outcomes (1)

• Number of patients with microbiological eradication at 2 weeks after neomycin administration

  Microbiological eradication is defined as the disappearance of CRE in hospitalized patients' faces at 2 weeks after neomycin administration

  2 weeks

Secondary Outcomes (5)

• Incidence of ์Neomycin toxicity (safety)

  2 weeks

• Incidence of ์carbapenemases in isolated CRE

  2 weeks

• Number of CRE isolates susceptible to neomycin at 2 weeks after neomycin administration

  2 weeks

• Number of CRE isolates susceptible to amikacin at 2 weeks after neomycin administration

  2 weeks

• Number of CRE isolates susceptible to gentamicin at 2 weeks after neomycin administration

  2 weeks

Study Arms (2)

Neomycin

ACTIVE COMPARATOR

Patients enrolled in this arm will receive Neomycin.

Drug: Neomycin

Non neomycin

NO INTERVENTION

Patients enrolled in this arm will not receive any interventions.

Interventions

Neomycin DRUG

Neomycin (350 mg/tablet) 1.4 g three times a day (4.2 g per day) for 5 days

Also known as: Neomycin Sulfate

Neomycin

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

RECRUITING

Related Publications (2)

• Hu Y, Liu L, Zhang X, Feng Y, Zong Z. In Vitro Activity of Neomycin, Streptomycin, Paromomycin and Apramycin against Carbapenem-Resistant Enterobacteriaceae Clinical Strains. Front Microbiol. 2017 Nov 17;8:2275. doi: 10.3389/fmicb.2017.02275. eCollection 2017.

  PMID: 29250040 BACKGROUND

• Park SY, Lee JS, Oh J, Lee SH, Jung J. Effectiveness of selective digestive decolonization therapy using oral gentamicin for eradication of carbapenem-resistant Enterobacteriaceae carriage. Infect Control Hosp Epidemiol. 2022 Nov;43(11):1580-1585. doi: 10.1017/ice.2021.492. Epub 2022 Feb 9.

  PMID: 35135653 BACKGROUND

MeSH Terms

Conditions

Asymptomatic Infections

Interventions

Neomycin

Condition Hierarchy (Ancestors)

Infections; Asymptomatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Adhiratha Boonyasiri, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adhiratha Boonyasiri, MD

CONTACT

+66850632181; adhiratha.bon@mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 25, 2022
• Study Start: November 24, 2022
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2024
• Last Updated: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)