Colonization, AsymptomaticPhase 4NCT05593601
Decolonization of Carbapenem-resistant Enterobacterales (CRE) in Patients With Faecal Carriage of CRE With Neomycin
A Phase 4 study testing Neomycin in people with Colonization, Asymptomatic, run by Mahidol University at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Colonization, Asymptomatic
- What is being tested?
- Neomycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 24 Nov 2022to 31 Mar 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, 10700
Adhiratha Boonyasiri, MD, +6624192688, adhiratha.bon@mahidol.ac.th
Adhiratha Boonyasiri, MD
About this study
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.
Read the 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.
- Conditions
- Colonization, Asymptomatic
- Being tested
- Neomycin
- Keywords
- Neomycin, CRE, carbapenem-resistant Enterobacterales
- Medical subject headings
- Asymptomatic Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeomycinDrug
Also called Neomycin Sulfate
Neomycin (350 mg/tablet) 1.4 g three times a day (4.2 g per day) for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Neomycin | Active comparator | Patients enrolled in this arm will receive Neomycin. Receives: Drug: Neomycin |
| Non neomycin | No intervention | Patients enrolled in this arm will not receive any interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks
Secondary outcomes (5)
Incidence of ์Neomycin toxicity (safety)
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Measured: 2 weeks
Incidence of ์carbapenemases in isolated CRE
Number of carbapenemases in isolated CRE
Measured: 2 weeks
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.
Measured: 2 weeks
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.
Measured: 2 weeks
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start24 Nov 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colonization, AsymptomaticStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adhiratha Boonyasiri, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593601
- Sponsor's protocol ID
- SI-CEU-02-2022
- Status last verified
- Nov 2022
- First submitted
- 17 Oct 2022
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29250040Park 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.
PubMed 35135653
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decolonization of Carbapenem-resistant Enterobacterales (CRE) in Patients With Faecal Carriage of CRE With Neomycin
- ClinicalTrials.gov ID
- NCT05593601
- Acronym / sponsor ID
- SI-CEU-02-2022
- Conditions
- Colonization, Asymptomatic
- Keywords
- Neomycin, CRE, carbapenem-resistant Enterobacterales
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 24 Nov 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 25 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neomycin | Active comparator | Drug: NeomycinPatients enrolled in this arm will receive Neomycin. |
| Non neomycin | No intervention | –Patients enrolled in this arm will not receive any interventions. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeomycinAlso: Neomycin SulfateNeomycin (350 mg/tablet) 1.4 g three times a day (4.2 g per day) for 5 days | Drug | Neomycin |
Primary outcome
Number of patients with microbiological eradication at 2 weeks after neomycin administration
Time frame: 2 weeks
Microbiological eradication is defined as the disappearance of CRE in hospitalized patients' faces at 2 weeks after neomycin administration
5 secondary outcomes
Incidence of ์Neomycin toxicity (safety)
Time frame: 2 weeks
Incidence of ์carbapenemases in isolated CRE
Time frame: 2 weeks
Number of CRE isolates susceptible to neomycin at 2 weeks after neomycin administration
Time frame: 2 weeks
Number of CRE isolates susceptible to amikacin at 2 weeks after neomycin administration
Time frame: 2 weeks
Number of CRE isolates susceptible to gentamicin at 2 weeks after neomycin administration
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Background: PubMed 29250040Hu 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.
- Background: PubMed 35135653Park 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adhiratha Boonyasiri, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Neomycin in people with Colonization, Asymptomatic, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adhiratha Boonyasiri, MD (+66850632181, adhiratha.bon@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with microbiological eradication at 2 weeks after neomycin administration (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05593601, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.