Eradication of carbapenem-resistant Klebsiella pneumoniae gastrointestinal colonization and prevention of invasive bloodstream infection by this organism Infections and Infestations
Conditions
Interventions
Current intervention as of 09/05/2023:
Active screening of eligible patients for gastrointestinal colonization with CRKP will be performed by way of rectal swabs according to the hospi
Sponsors
Sultan Qaboos University
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 09/05/2023: CRKP eradication: Eradication [clearance] rate of CS-CRKP assessed by culture positivity of rectal swabs for CRKP at day 14 [day 7 post Rx] _____ Previous primary outcome measures: 1. Eradication of CRKP assessed by culture positivity of rectal swabs for CRKP at day 28 post-intervention 2. CRKP bloodstream infection (bacteremia) assessed by blood culture for 28 days post-intervention 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measure as of 09/05/2023: 1. Incidence of CS-CRKP bacteremia during the same hospitalization 2. In-hospital all-cause mortality during the same hospitalization 3. Incidence of colistin resistance in positive rectal swabs at day 14 [day 7 post Rx] _____ Previous secondary outcome measures: Development of resistance to colistin evaluated by performing susceptibility testing of colistin for all post-intervention CRKP isolates from any site for 28 days | — |
Countries
Oman
Outcome results
None listed