Clinical trial NCT05593601: Decolonization of Carbapenem-resistant Enterobacterales (CRE) in Patients With Faecal Carriage of CRE With Neomycin
Official title: Decolonization of Carbapenem-resistant Enterobacterales (CRE) in Patients With Faecal Carriage of CRE With Neomycin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Colonization, Asymptomatic
Keywords: Neomycin
CRE
carbapenem-resistant Enterobacterales
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2022-10-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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, 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

Primary outcomes:
measure: Number of patients with microbiological eradication at 2 weeks after neomycin administration
timeFrame: 2 weeks
Secondary outcomes:
measure: Incidence of ์Neomycin toxicity (safety)
timeFrame: 2 weeks
measure: Incidence of ์carbapenemases in isolated CRE
timeFrame: 2 weeks
measure: Number of CRE isolates susceptible to neomycin at 2 weeks after neomycin administration
timeFrame: 2 weeks
measure: Number of CRE isolates susceptible to amikacin at 2 weeks after neomycin administration
timeFrame: 2 weeks
measure: Number of CRE isolates susceptible to gentamicin at 2 weeks after neomycin administration
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
Study officials:
affiliation: Mahidol University
name: Adhiratha Boonyasiri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.