Decolonization of Carbapenem-resistant Enterobacterales (CRE) in Patients With Faecal Carriage of CRE With Neomycin
Primary Purpose
Colonization, Asymptomatic
Status
Recruiting
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Neomycin
Sponsored by
About this trial
This is an interventional treatment trial for Colonization, Asymptomatic focused on measuring Neomycin, CRE, carbapenem-resistant Enterobacterales
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
Sites / Locations
- Faculty of Medicine Siriraj Hospital, Mahidol UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Neomycin
Non neomycin
Arm Description
Patients enrolled in this arm will receive Neomycin.
Patients enrolled in this arm will not receive any interventions.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Incidence of ์Neomycin toxicity (safety)
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Incidence of ์carbapenemases in isolated CRE
Number of carbapenemases in isolated CRE
Number of CRE isolates susceptible to neomycin at 2 weeks after neomycin administration
Number of CRE isolates are susceptible to neomycin at 2 weeks after neomycin administration according to the Clinical and Laboratory Standards Institute (CLSI) guideline.
Number of CRE isolates susceptible to amikacin at 2 weeks after neomycin administration
Number of CRE isolates are susceptible to amikacin after at 2 weeks after neomycin administration according to the Clinical and Laboratory Standards Institute (CLSI) guideline.
Number of CRE isolates susceptible to gentamicin at 2 weeks after neomycin administration
Number of CRE isolates are susceptible to gentamicin at 2 weeks after neomycin administration according to the Clinical and Laboratory Standards Institute (CLSI) guideline.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05593601
Brief Title
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 24, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonization, Asymptomatic
Keywords
Neomycin, CRE, carbapenem-resistant Enterobacterales
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Neomycin
Arm Type
Active Comparator
Arm Description
Patients enrolled in this arm will receive Neomycin.
Arm Title
Non neomycin
Arm Type
No Intervention
Arm Description
Patients enrolled in this arm will not receive any interventions.
Intervention Type
Drug
Intervention Name(s)
Neomycin
Other Intervention Name(s)
Neomycin Sulfate
Intervention Description
Neomycin (350 mg/tablet) 1.4 g three times a day (4.2 g per day) for 5 days
Primary Outcome Measure Information:
Title
Number of patients with microbiological eradication at 2 weeks after neomycin administration
Description
Microbiological eradication is defined as the disappearance of CRE in hospitalized patients' faces at 2 weeks after neomycin administration
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Incidence of ์Neomycin toxicity (safety)
Description
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time Frame
2 weeks
Title
Incidence of ์carbapenemases in isolated CRE
Description
Number of carbapenemases in isolated CRE
Time Frame
2 weeks
Title
Number of CRE isolates susceptible to neomycin at 2 weeks after neomycin administration
Description
Number of CRE isolates are susceptible to neomycin at 2 weeks after neomycin administration according to the Clinical and Laboratory Standards Institute (CLSI) guideline.
Time Frame
2 weeks
Title
Number of CRE isolates susceptible to amikacin at 2 weeks after neomycin administration
Description
Number of CRE isolates are susceptible to amikacin after at 2 weeks after neomycin administration according to the Clinical and Laboratory Standards Institute (CLSI) guideline.
Time Frame
2 weeks
Title
Number of CRE isolates susceptible to gentamicin at 2 weeks after neomycin administration
Description
Number of CRE isolates are susceptible to gentamicin at 2 weeks after neomycin administration according to the Clinical and Laboratory Standards Institute (CLSI) guideline.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adhiratha Boonyasiri, MD
Phone
+66850632181
Email
adhiratha.bon@mahidol.ac.th
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adhiratha Boonyasiri, MD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Siriraj Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adhiratha Boonyasiri, MD
Phone
+6624192688
Email
adhiratha.bon@mahidol.ac.th
First Name & Middle Initial & Last Name & Degree
Adhiratha Boonyasiri, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29250040
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.
Results Reference
background
PubMed Identifier
35135653
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.
Results Reference
background
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Decolonization of Carbapenem-resistant Enterobacterales (CRE) in Patients With Faecal Carriage of CRE With Neomycin
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