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Colistin Versus Colistin Plus Fosfomycin for Infections Caused by MDR Acinetobacter Baumannii

Sponsor
Mahidol University (Other)
Overall Status
Unknown status
CT.gov ID
NCT01297894
Collaborator
(none)
92
Enrollment
1
Location
2
Arms
23
Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In Siriraj Hospital, colistin alone for treatment of MDR A. baumannii contributed to mortality 45% Fosfomycin is an antimicrobial which has activity against gram-negative bacterial including MDR A. baumannii In this study, we compare the clinical and microbiologicalresponse of colistin alone versus colistin plus fosfomycin in treatment of A. baumannii infected patients

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Inclusion criteria

  • Age> 18 years

  • Hospitalized to Siriraj Hospital

  • Infected caused by A. baumannii

  • Need Colistin treatment

Exclusion criteria

  • Pregnancy or Lactating mother

  • Colistin or Fosfomycin Allergy

  • Patients who have severe abnormal renal or liver function

Study Design

Study Type:
Interventional
Anticipated Enrollment :
92 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Colistin Plus Fosfomycin in Multi-Drug Resistant Acinetobacter Baumannii
Study Start Date :
Jun 1, 2010
Anticipated Primary Completion Date :
May 1, 2012
Anticipated Study Completion Date :
May 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: colistin

Colistimethate sodium 2.5-5mg/kg iv

Drug: colistin
Colistimethate sodium 2.5-5mg/kg of colistin base
Other Names:
  • Colistate

    		•
    Active Comparator: colistin plus fosfomycin

    colistimethate sodium 2.5-5mg/kg iv plus fosfomycin 2gm iv every 12 hours

    Drug: colistin plus fosfomycin
    colitimethate sodium 2.5-5mg/kg iv plus fosfomycin 2gm iv every 12 hours
    Other Names:
  • Colistate
  • Fosmicin

    		•

    Outcome Measures

    Primary Outcome Measures

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

      cure improvement worse death

    Secondary Outcome Measures

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

      eradication persistence superinfection

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age> 18 years

    • Hospitalized to Siriraj Hospital

    • Infected caused by A. baumannii

    • Need Colistin treatment

    Exclusion criteria:

    • Pregnancy or Lactating mother

    • Colistin or Fosfomycin Allergy

    • Patients who have severe abnormal renal or liver function

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Siriraj Hospital Bangkok Thailand 10700

    Sponsors and Collaborators

    • Mahidol University

    Investigators

    • Principal Investigator: Visanu Thamlikitkul, MD, Faculty of Medicine Siriraj Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Visanu Thamlikitkul, Division of Infectious Diseases and tropical medicine, Department of medicine, Faculty of Medicine Siriraj Hospital., Mahidol University
    ClinicalTrials.gov Identifier:
    NCT01297894
    Other Study ID Numbers:
    • Siriraj CEU53-001
    First Posted:
    Feb 17, 2011
    Last Update Posted:
    Dec 29, 2011
    Last Verified:
    Dec 1, 2011
    Keywords provided by Visanu Thamlikitkul, Division of Infectious Diseases and tropical medicine, Department of medicine, Faculty of Medicine Siriraj Hospital., Mahidol University
    A. baumannii
    colistin
    fosfomycin
    Additional relevant MeSH terms:
    Colistin
    Fosfomycin

    Study Results

    No Results Posted as of Dec 29, 2011