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

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:
NCT01297894
First received: February 15, 2011
Last updated: December 24, 2011
Last verified: December 2011
History of Changes
  Purpose

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 Intervention Phase
Drug Safety
 Drug: colistin
Drug: colistin plus fosfomycin
 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: Colistin Plus Fosfomycin in Multi-Drug Resistant Acinetobacter Baumannii

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 28days ] [ Designated as safety issue: Yes ]
    cure improvement worse death


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


Estimated Enrollment: 92
Study Start Date: June 2010
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: colistin
Colistimethate sodium 2.5-5mg/kg iv
 Drug: colistin
Colistimethate sodium 2.5-5mg/kg of colistin base
Other Name: 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

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01297894

Contacts
Contact: Dr Visanu Thamlikitkul, Professor 662-419-6626 sivth@mahidol.ac.th
Contact: Dr Pornpan Koomanachai, MD 662-419-7783 nokmed@yahoo.com

Locations
Thailand
Siriraj Hospital Recruiting
Bangkok, Thailand, 10700
Contact: Dr. Visanu Thamlikitkul, Professor     662-419-6626     sivth@mahidol.ac.th    
Contact: Dr. Pornpan Koomanachai, MD     662-419-7783     nokmed@yahoo.com    
Principal Investigator: Dr. Pornpan Koomanachai, MD            
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Visanu Thamlikitkul, MD Faculty of Medicine Siriraj Hospital
  More Information

No publications 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     History of Changes
Other Study ID Numbers: Siriraj CEU53-001
Study First Received: February 15, 2011
Last Updated: December 24, 2011
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
A. baumannii
colistin
fosfomycin

Additional relevant MeSH terms:
Colistin
Fosfomycin
Anti-Bacterial Agents
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013