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

This study is currently recruiting participants.
Verified December 2011 by Mahidol University
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
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by Mahidol University:

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


Secondary Outcome Measures:
  • number of subjects with eradication of causative bacteria [ Time Frame: up to day 28 ] [ Designated as safety issue: Yes ]
    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
Colistate
 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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01297855

Contacts
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

Locations
Thailand
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     sivth@mahidol.ac.th    
Contact: Sunee Thanakhumtorn     662 419 7000 ext 6616     srstn@mahidol.ac.th    
Principal Investigator: Sukij Piyasirisilp, MD            
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Sukij Piyasirisilp, MD Siriraj Hospital
  More Information

No publications provided

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

Additional relevant MeSH terms:
Colistin
Rifampin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
 Antibiotics, Antitubercular
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013