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

Mahidol University

Status and phase: Unknown; Phase 3

Conditions: Drug Safety

Treatments: Drug: colistin plus fosfomycin; Drug: colistin

Study type: Interventional

Funder types: Other

Identifiers

NCT01297894

Siriraj CEU53-001

Details and patient eligibility

About

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

Full 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

Enrollment: 92 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

colistin

Active Comparator group

Description:

Colistimethate sodium 2.5-5mg/kg iv

Treatment:

Drug: colistin

colistin plus fosfomycin

Active Comparator group

Description:

colistimethate sodium 2.5-5mg/kg iv plus fosfomycin 2gm iv every 12 hours

Treatment:

Drug: colistin plus fosfomycin