Drug Safety
Conditions
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.
Interventions
DRUGColistin
Colistimethate Sodium dose 2.5-5mg/kg/day
DRUGColistin plus Rifampicin
Colistin 2.5 to 5 mg/ Kg/ day Rifampin 10 mg/ Kg/ day
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of subjects with cure or improvement | up to day 28 | Cure Improvement Worse Death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of subjects with eradication of causative bacteria | up to day 28 | Eradication Persistence Superinfection |
Countries
Thailand
Contacts
Primary ContactVisanu Thamlikitkul, Professor
Backup ContactSunee Thanakhumtorn
Outcome results
None listed