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

Phase 3
Conditions
Drug Safety
Interventions
Registration Number
NCT01297894
Lead Sponsor
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

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

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
92
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
Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
colistin plus fosfomycincolistin plus fosfomycincolistimethate sodium 2.5-5mg/kg iv plus fosfomycin 2gm iv every 12 hours
colistincolistinColistimethate sodium 2.5-5mg/kg iv
Primary Outcome Measures
NameTimeMethod
number of subjects with cure or improvementup to 28days

cure improvement worse death

Secondary Outcome Measures
NameTimeMethod
number of subjects with eradication of causative bacteriaup to 28days

eradication persistence superinfection

Trial Locations

Locations (1)

Siriraj Hospital

🇹🇭

Bangkok, Thailand

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