Colistin Plus Rifampicin in MDR P. Aeruginosa and A. Baumanii

Phase 3

• Conditions: Drug Safety
• Interventions: Drug: Colistin plus Rifampicin; Drug: Colistin

• 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

Study Timeline

• Study First Submitted: 2009-07-20
• Study Start: 2010-06
• Study First Submitted QC: 2011-02-15
• Study First Posted: 2011-02-17
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-29
• Last Update Posted: 2012-01-02
• Primary Completion: 2012-05
• Study Completion: 2012-08

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