Colistin Versus Colistin Plus Fosfomycin for Infections Caused by MDR Acinetobacter Baumannii
Colistin Plus Fosfomycin in Multi-Drug Resistant Acinetobacter Baumannii
1 other identifier
interventional
92
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 15, 2011
CompletedFirst Posted
Study publicly available on registry
February 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedDecember 29, 2011
December 1, 2011
1.9 years
February 15, 2011
December 24, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of subjects with cure or improvement
cure improvement worse death
up to 28days
Secondary Outcomes (1)
number of subjects with eradication of causative bacteria
up to 28days
Study Arms (2)
colistin
ACTIVE COMPARATORColistimethate sodium 2.5-5mg/kg iv
colistin plus fosfomycin
ACTIVE COMPARATORcolistimethate sodium 2.5-5mg/kg iv plus fosfomycin 2gm iv every 12 hours
Interventions
colitimethate sodium 2.5-5mg/kg iv plus fosfomycin 2gm iv every 12 hours
Eligibility Criteria
You may qualify if:
- Age\> 18 years
- Hospitalized to Siriraj Hospital
- Infected caused by A. baumannii
- Need Colistin treatment
You may not qualify if:
- Pregnancy or Lactating mother
- Colistin or Fosfomycin Allergy
- Patients who have severe abnormal renal or liver function
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Siriraj Hospital
Bangkok, Bangkok, 10700, Thailand
Related Publications (1)
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.
PMID: 24982065DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Visanu Thamlikitkul, MD
Siriraj Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Division of Infectious Diseases and tropical medicine, Department of medicine, Faculty of Medicine Siriraj Hospital.
Study Record Dates
First Submitted
February 15, 2011
First Posted
February 17, 2011
Study Start
June 1, 2010
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
December 29, 2011
Record last verified: 2011-12