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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by Mahidol University.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Visanu Thamlikitkul, Mahidol University Identifier:
First received: July 20, 2009
Last updated: December 29, 2011
Last verified: December 2011

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.

Condition Intervention Phase
Drug Safety
Drug: Colistin
Drug: Colistin plus Rifampicin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Colistin Versus Colistin Plus Rifampicin in MDR P.Aeruginosa and A.Baumanii

Resource links provided by NLM:

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • number of subjects with cure or improvement [ Time Frame: up to day 28 ]
    Cure Improvement Worse Death

Secondary Outcome Measures:
  • number of subjects with eradication of causative bacteria [ Time Frame: up to day 28 ]
    Eradication Persistence Superinfection

Estimated Enrollment: 130
Study Start Date: June 2010
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Colistin
Drug: Colistin
Colistimethate Sodium dose 2.5-5mg/kg/day
Other Name: Colistate
Experimental: Colistin plus Rifampicin
Colistate Rifampin
Drug: Colistin plus Rifampicin
Colistin 2.5 to 5 mg/ Kg/ day Rifampin 10 mg/ Kg/ day
Other Names:
  • Colistate
  • Rifampin


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01297855

Contact: Visanu Thamlikitkul, Professor 662 419 7000 ext 6626
Contact: Sunee Thanakhumtorn 662 419 7000 ext 6616

Division of Infectious disease and Tropical Medicine, Department of Medicine, Faculty of Medicine Siriraj Hospital Recruiting
Bangkoknoi, Bangkok, Thailand, 10700
Contact: Visanu Thamlikitkul, Professor    662 419 7000 ext 6626   
Contact: Sunee Thanakhumtorn    662 419 7000 ext 6616   
Principal Investigator: Sukij Piyasirisilp, MD         
Sponsors and Collaborators
Mahidol University
Principal Investigator: Sukij Piyasirisilp, MD Siriraj Hospital
  More Information

Responsible Party: Visanu Thamlikitkul, Department of Medicine, Faculty of Medicine Siriraj Hospital, Bangkok, Thailand, Mahidol University Identifier: NCT01297855     History of Changes
Other Study ID Numbers: SirirajCEU51-001
Study First Received: July 20, 2009
Last Updated: December 29, 2011

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antitubercular
Antitubercular Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers processed this record on May 25, 2017