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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Mahidol University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Visanu Thamlikitkul, Mahidol University
ClinicalTrials.gov Identifier:
NCT01297855
First received: July 20, 2009
Last updated: December 29, 2011
Last verified: December 2011

July 20, 2009
December 29, 2011
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 ] [ Designated as safety issue: Yes ]
Cure Improvement Worse Death
Same as current
Complete list of historical versions of study NCT01297855 on ClinicalTrials.gov Archive Site
number of subjects with eradication of causative bacteria [ Time Frame: up to day 28 ] [ Designated as safety issue: Yes ]
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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
    Colistate
    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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
130
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
Both
18 Years to 80 Years
No
Contact: Visanu Thamlikitkul, Professor 662 419 7000 ext 6626 sivth@mahidol.ac.th
Contact: Sunee Thanakhumtorn 662 419 7000 ext 6616 srstn@mahidol.ac.th
Thailand
 
NCT01297855
SirirajCEU51-001
No
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