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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01297855
Recruitment Status : Unknown
Verified December 2011 by Visanu Thamlikitkul, Mahidol University.
Recruitment status was:  Recruiting
First Posted : February 17, 2011
Last Update Posted : January 2, 2012
Information provided by (Responsible Party):
Visanu Thamlikitkul, Mahidol University

July 20, 2009
February 17, 2011
January 2, 2012
June 2010
May 2012   (Final data collection date for primary outcome measure)
number of subjects with cure or improvement [ Time Frame: up to day 28 ]
Cure Improvement Worse Death
Same as current
Complete list of historical versions of study NCT01297855 on Archive Site
number of subjects with eradication of causative bacteria [ Time Frame: up to day 28 ]
Eradication Persistence Superinfection
Same as current
Not Provided
Not Provided
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

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.

Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Drug Safety
  • Drug: Colistin
    Colistimethate Sodium dose 2.5-5mg/kg/day
    Other Name: Colistate
  • Drug: Colistin plus Rifampicin
    Colistin 2.5 to 5 mg/ Kg/ day Rifampin 10 mg/ Kg/ day
    Other Names:
    • Colistate
    • Rifampin
  • Active Comparator: Colistin
    Intervention: Drug: Colistin
  • Experimental: Colistin plus Rifampicin
    Colistate Rifampin
    Intervention: Drug: Colistin plus Rifampicin
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
August 2012
May 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Visanu Thamlikitkul, Mahidol University
Mahidol University
Not Provided
Principal Investigator: Sukij Piyasirisilp, MD Siriraj Hospital
Mahidol University
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP