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

Sponsor
Mahidol University (Other)
Overall Status
Unknown status
CT.gov ID
NCT01297855
Collaborator
(none)
130
Enrollment
1
Location
2
Arms
26
Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
130 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Controlled Trial of Colistin Versus Colistin Plus Rifampicin in MDR P.Aeruginosa and A.Baumanii
Study Start Date :
Jun 1, 2010
Anticipated Primary Completion Date :
May 1, 2012
Anticipated Study Completion Date :
Aug 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Colistin

Colistate

Drug: Colistin
Colistimethate Sodium dose 2.5-5mg/kg/day
Other Names:
  • 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. number of subjects with cure or improvement [up to day 28]

      Cure Improvement Worse Death

    Secondary Outcome Measures

    1. number of subjects with eradication of causative bacteria [up to day 28]

      Eradication Persistence Superinfection

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    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

    Locations

    Site City State Country Postal Code
    1 Division of Infectious disease and Tropical Medicine, Department of Medicine, Faculty of Medicine Siriraj Hospital Bangkoknoi Bangkok Thailand 10700

    Sponsors and Collaborators

    • Mahidol University

    Investigators

    • Principal Investigator: Sukij Piyasirisilp, MD, Siriraj Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Visanu Thamlikitkul, Department of Medicine, Faculty of Medicine Siriraj Hospital, Bangkok, Thailand, Mahidol University
    ClinicalTrials.gov Identifier:
    NCT01297855
    Other Study ID Numbers:
    • SirirajCEU51-001
    First Posted:
    Feb 17, 2011
    Last Update Posted:
    Jan 2, 2012
    Last Verified:
    Dec 1, 2011
    Additional relevant MeSH terms:
    Rifampin
    Colistin

    Study Results

    No Results Posted as of Jan 2, 2012