Colistin Plus Rifampicin in MDR P. Aeruginosa and A. Baumanii
Randomized Controlled Trial of Colistin Versus Colistin Plus Rifampicin in MDR P.Aeruginosa and A.Baumanii
1 other identifier
interventional
130
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2009
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedFirst Posted
Study publicly available on registry
February 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedJanuary 2, 2012
December 1, 2011
1.9 years
July 20, 2009
December 29, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
number of subjects with cure or improvement
Cure Improvement Worse Death
up to day 28
Secondary Outcomes (1)
number of subjects with eradication of causative bacteria
up to day 28
Study Arms (2)
Colistin
ACTIVE COMPARATORColistate
Colistin plus Rifampicin
EXPERIMENTALColistate Rifampin
Interventions
Colistin 2.5 to 5 mg/ Kg/ day Rifampin 10 mg/ Kg/ day
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Infectious disease and Tropical Medicine, Department of Medicine, Faculty of Medicine Siriraj Hospital
Bangkoknoi, Bangkok, 10700, Thailand
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sukij Piyasirisilp, MD
Siriraj Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Medicine, Faculty of Medicine Siriraj Hospital, Bangkok, Thailand
Study Record Dates
First Submitted
July 20, 2009
First Posted
February 17, 2011
Study Start
June 1, 2010
Primary Completion
May 1, 2012
Study Completion
August 1, 2012
Last Updated
January 2, 2012
Record last verified: 2011-12