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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-24

Study Completion Date

2024-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Colonization, Asymptomatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Neomycin

Patients enrolled in this arm will receive Neomycin.

Group Type ACTIVE_COMPARATOR

Neomycin

Intervention Type DRUG

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

Non neomycin

Patients enrolled in this arm will not receive any interventions.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Neomycin

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

Intervention Type DRUG

Other Intervention Names

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Neomycin Sulfate

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No