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

Information source: Mahidol University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Drug Safety

Intervention: colistin (Drug); colistin plus fosfomycin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Mahidol University

Official(s) and/or principal investigator(s):
Visanu Thamlikitkul, MD, Principal Investigator, Affiliation: Faculty of Medicine Siriraj Hospital

Overall contact:
Dr Visanu Thamlikitkul, Professor, Phone: 662-419-6626, Email: sivth@mahidol.ac.th

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

Clinical Details

Official title: Colistin Plus Fosfomycin in Multi-Drug Resistant Acinetobacter Baumannii

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: number of subjects with cure or improvement

Secondary outcome: number of subjects with eradication of causative bacteria

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Dr Visanu Thamlikitkul, Professor, Phone: 662-419-6626, Email: sivth@mahidol.ac.th

Siriraj Hospital, Bangkok 10700, Thailand; Recruiting
Dr. Visanu Thamlikitkul, Professor, Phone: 662-419-6626, Email: sivth@mahidol.ac.th
Dr. Pornpan Koomanachai, MD, Phone: 662-419-7783, Email: nokmed@yahoo.com
Dr. Pornpan Koomanachai, MD, Principal Investigator
Additional Information

Starting date: June 2010
Last updated: December 24, 2011

Page last updated: August 23, 2015

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