Colistin Plus Rifampicin in MDR P. Aeruginosa and A. Baumanii
- Registration Number
- NCT01297855
- Lead Sponsor
- Mahidol University
- Brief Summary
In Siriraj Hospital, Colistin alone for treatment of MDR. A.baumanii or P.aeruginosa contributed to mortality 45%. In vitro studies revealed synergism of Rifampicin and Colistin.
In this study, patients with documented MDR. P.aeruginosa or A.baumanii will be allocated to receive Colistin alone and another group will receive Colistin plus Rifampicin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 130
Inclusion Criteria
- Age>18 years
- Hospitalized to Siriraj Hospital
- Infection with MDR A.baumanii or P.aeruginosa
- Nescessary for treatment with Colistin
- Patient agrees to participate by giving written informed consent.
Exclusion Criteria
- pregnancy or lactating mother
- Colistin or Rifampicin allergy
- Active hepatic disease or abnormal liver function test
- patient who suspected infection with mycobacterium tuberculosis
- patient who can not drug by enteral feeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Colistin plus Rifampicin Colistin plus Rifampicin Colistate Rifampin Colistin Colistin Colistate
- Primary Outcome Measures
Name Time Method number of subjects with cure or improvement up to day 28 Cure Improvement Worse Death
- Secondary Outcome Measures
Name Time Method number of subjects with eradication of causative bacteria up to day 28 Eradication Persistence Superinfection
Trial Locations
- Locations (1)
Division of Infectious disease and Tropical Medicine, Department of Medicine, Faculty of Medicine Siriraj Hospital
🇹🇭Bangkoknoi, Bangkok, Thailand