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

NCT ID: NCT01297894

Last Updated: 2011-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-05-31

Brief Summary

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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

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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

Conditions

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Drug Safety

Keywords

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A. baumannii colistin fosfomycin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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colistin

Colistimethate sodium 2.5-5mg/kg iv

Group Type ACTIVE_COMPARATOR

colistin

Intervention Type DRUG

Colistimethate sodium 2.5-5mg/kg of colistin base

colistin plus fosfomycin

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

Group Type ACTIVE_COMPARATOR

colistin plus fosfomycin

Intervention Type DRUG

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

Interventions

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colistin

Colistimethate sodium 2.5-5mg/kg of colistin base

Intervention Type DRUG

colistin plus fosfomycin

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

Intervention Type DRUG

Other Intervention Names

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Colistate Colistate Fosmicin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Visanu Thamlikitkul

Division of Infectious Diseases and tropical medicine, Department of medicine, Faculty of Medicine Siriraj Hospital.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Visanu Thamlikitkul, MD

Role: PRINCIPAL_INVESTIGATOR

Siriraj Hospital

Locations

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Siriraj Hospital

Bangkok, Bangkok, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Dr Visanu Thamlikitkul, Professor

Role: CONTACT

Phone: 662-419-6626

Email: [email protected]

Dr Pornpan Koomanachai, MD

Role: CONTACT

Phone: 662-419-7783

Email: [email protected]

Facility Contacts

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Dr. Visanu Thamlikitkul, Professor

Role: primary

Dr. Pornpan Koomanachai, MD

Role: backup

References

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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.

Reference Type DERIVED
PMID: 24982065 (View on PubMed)

Other Identifiers

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Siriraj CEU53-001

Identifier Type: -

Identifier Source: org_study_id