Colistin Versus Colistin Plus Fosfomycin for Infections C... | NCT01297894

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

NCT01297894

Sponsor

Mahidol University

Status

Unknown status

Last Update Posted

Dec 29, 2011Estimated

Enrollment

92Estimated

Phase

Phase 3

Conditions

Drug Safety

Interventions

colistin
colistin plus fosfomycin

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

May 2012Estimated

Completion Date

May 2012Estimated

First Submitted Date

Feb 15, 2011

First Submission Date that Met QC Criteria

Feb 16, 2011

First Posted Date

Feb 17, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 24, 2011

Last Update Posted Date

Dec 29, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Visanu Thamlikitkul, Division of Infectious Diseases and tropical medicine, Department of medicine, Faculty of Medicine Siriraj Hospital., Mahidol UniversityPrincipal Investigator

Lead Sponsor

Mahidol UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

92Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
colistin	Active Comparator	Colistimethate sodium 2.5-5mg/kg iv	Drug: colistin
colistin plus fosfomycin	Active Comparator	colistimethate sodium 2.5-5mg/kg iv plus fosfomycin 2gm iv every 12 hours	Drug: colistin plus fosfomycin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
colistin	Drug	Colistimethate sodium 2.5-5mg/kg of colistin base	colistin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of subjects with cure or improvement	cure improvement worse death	up to 28days

Secondary Outcomes

Measure	Description	Time Frame
number of subjects with eradication of causative bacteria	eradication persistence superinfection	up to 28days

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dr Visanu Thamlikitkul, Professor	Contact	662-419-6626		sivth@mahidol.ac.th
Dr Pornpan Koomanachai, MD	Contact	662-419-7783		nokmed@yahoo.com

Overall Officials

Name	Affiliation	Role
Visanu Thamlikitkul, MD	Siriraj Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Siriraj Hospital	Recruiting	Bangkok	Bangkok	10700	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24982065	Derived	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.

ID	Term
D011113	Polymyxins
D010456	Peptides, Cyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds