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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Mahidol University.
Recruitment status was  Recruiting
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

February 15, 2011
December 24, 2011
June 2010
May 2012   (final data collection date for primary outcome measure)
number of subjects with cure or improvement [ Time Frame: up to 28days ] [ Designated as safety issue: Yes ]
cure improvement worse death
Same as current
Complete list of historical versions of study NCT01297894 on ClinicalTrials.gov Archive Site
number of subjects with eradication of causative bacteria [ Time Frame: up to 28days ] [ Designated as safety issue: Yes ]
eradication persistence superinfection
Same as current
Not Provided
Not Provided
 
Colistin Versus Colistin Plus Fosfomycin for Infections Caused by MDR Acinetobacter Baumannii
Colistin Plus Fosfomycin in Multi-Drug Resistant Acinetobacter Baumannii

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

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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Drug Safety
  • Drug: colistin
    Colistimethate sodium 2.5-5mg/kg of colistin base
    Other Name: Colistate
  • Drug: colistin plus fosfomycin
    colitimethate sodium 2.5-5mg/kg iv plus fosfomycin 2gm iv every 12 hours
    Other Names:
    • Colistate
    • Fosmicin
  • Active Comparator: colistin
    Colistimethate sodium 2.5-5mg/kg iv
    Intervention: Drug: colistin
  • Active Comparator: colistin plus fosfomycin
    colistimethate sodium 2.5-5mg/kg iv plus fosfomycin 2gm iv every 12 hours
    Intervention: Drug: colistin plus fosfomycin
Sirijatuphat R, Thamlikitkul V. Preliminary study of colistin versus colistin plus fosfomycin for treatment of carbapenem-resistant Acinetobacter baumannii infections. Antimicrob Agents Chemother. 2014 Sep;58(9):5598-601. doi: 10.1128/AAC.02435-13. Epub 2014 Jun 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
92
May 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Dr Visanu Thamlikitkul, Professor 662-419-6626 sivth@mahidol.ac.th
Contact: Dr Pornpan Koomanachai, MD 662-419-7783 nokmed@yahoo.com
Thailand
 
NCT01297894
Siriraj CEU53-001
No
Visanu Thamlikitkul, Mahidol University
Mahidol University
Not Provided
Principal Investigator: Visanu Thamlikitkul, MD Faculty of Medicine Siriraj Hospital
Mahidol University
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP