Does oral colistin (antibiotic) eradicate extensively drug-resistant bacteria (Klebsiella) from the gastrointestinal tract?

Not Applicable

• Conditions: Eradication of carbapenem-resistant Klebsiella pneumoniae gastrointestinal colonization and prevention of invasive bloodstream infection by this organism; Infections and Infestations

• Registration Number: ISRCTN70235902
• Lead Sponsor: Sultan Qaboos University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-12
• Last Update Posted: 9 October 2023
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

Current inclusion criteria as of 09/05/2023:
1. Adult: Aged >18 years
2. Location: ICU, HD, Hematology
3. Able to provide informed consent
4. Expected to stay for 14 days in hospital
5. Undergone a screening rectal swab for CRKP within 72 h of admission
_____

Previous inclusion criteria:
1. Aged =18 years
2. Admitted to intensive care, high dependency, and hematology wards at SQUH, Oman during the study period
3. Positive screening rectal swab for CRKP [colistin susceptible]
4. Able to provide informed consent

Exclusion Criteria

Current exclusion criteria as of 09/05/2023:
1. Not meeting inclusion criteria
2. Rectal swab is negative for CRKP
3. CRKP is colistin-resistant [MIC >2 mg/L)
4. Pregnant or nursing women
5. Known hypersensitivity to colistin/placebo
6. NPO [nil by mouth]
7. On colistin OR ceftazidime-avibactam/aztreonam at time of enrollment or up to 7 days before enrollment

_____

Previous exclusion criteria:
1. Age <18 years
2. Pregnant or nursing women
3. Known hypersensitivity
4. Gastrointestinal colonization with colistin-resistant Klebsiella pneumonia
5. Enrollment in the present study for a previous episode

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measure as of 09/05/2023:<br> CRKP eradication: Eradication [clearance] rate of CS-CRKP assessed by culture positivity of rectal swabs for CRKP at day 14 [day 7 post Rx]<br> _____<br><br> Previous primary outcome measures:<br> 1. Eradication of CRKP assessed by culture positivity of rectal swabs for CRKP at day 28 post-intervention<br> 2. CRKP bloodstream infection (bacteremia) assessed by blood culture for 28 days post-intervention<br> 3. CRKP-related death will be captured by active follow-up of patients in both groups during hospitalization and for 28 days, whichever is longer<br>

Secondary Outcome Measures

Name	Time	Method
<br> Current secondary outcome measure as of 09/05/2023:<br> 1. Incidence of CS-CRKP bacteremia during the same hospitalization<br> 2. In-hospital all-cause mortality during the same hospitalization<br> 3. Incidence of colistin resistance in positive rectal swabs at day 14 [day 7 post Rx]<br> _____<br><br> Previous secondary outcome measures:<br> Development of resistance to colistin evaluated by performing susceptibility testing of colistin for all post-intervention CRKP isolates from any site for 28 days<br>