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

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ClinicalTrials.gov Identifier: NCT01297894
Recruitment Status : Unknown
Verified December 2011 by Visanu Thamlikitkul, Mahidol University.
Recruitment status was:  Recruiting
First Posted : February 17, 2011
Last Update Posted : December 29, 2011
Sponsor:
Information provided by (Responsible Party):
Visanu Thamlikitkul, Mahidol University

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
Drug Safety Drug: colistin Drug: colistin plus fosfomycin 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 Type : Interventional  (Clinical Trial)
Estimated 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 : June 2010
Estimated Primary Completion Date : May 2012
Estimated Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 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



Primary Outcome Measures :
  1. number of subjects with cure or improvement [ Time Frame: up to 28days ]
    cure improvement worse death


Secondary Outcome Measures :
  1. number of subjects with eradication of causative bacteria [ Time Frame: up to 28days ]
    eradication persistence superinfection



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: February 17, 2011    Key Record Dates
Last Update Posted: December 29, 2011
Last Verified: December 2011

Keywords provided by Visanu Thamlikitkul, Mahidol University:
A. baumannii
colistin
fosfomycin

Additional relevant MeSH terms:
Colistin
Fosfomycin
Anti-Bacterial Agents
Anti-Infective Agents