Colistin Plus Rifampicin in MDR P. Aeruginosa and A. Baum... | NCT01297855

Studies
Colistin Plus Rifampicin in MDR P. Aeruginosa and A. Baumanii

NCT01297855

Sponsor

Mahidol University

Status

Unknown status

Last Update Posted

Jan 2, 2012Estimated

Enrollment

130Estimated

Phase

Phase 3

Conditions

Drug Safety

Interventions

Colistin
Colistin plus Rifampicin

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

Aug 2012Estimated

First Submitted Date

Jul 20, 2009

First Submission Date that Met QC Criteria

Feb 15, 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 29, 2011

Last Update Posted Date

Jan 2, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Visanu Thamlikitkul, Department of Medicine, Faculty of Medicine Siriraj Hospital, Bangkok, Thailand, 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.baumanii or P.aeruginosa contributed to mortality 45%. In vitro studies revealed synergism of Rifampicin and Colistin.

In this study, patients with documented MDR. P.aeruginosa or A.baumanii will be allocated to receive Colistin alone and another group will receive Colistin plus Rifampicin.

Detailed Description

Not provided

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

130Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Colistin	Active Comparator	Colistate	Drug: Colistin
Colistin plus Rifampicin	Experimental	Colistate Rifampin	Drug: Colistin plus Rifampicin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Colistin	Drug	Colistimethate Sodium dose 2.5-5mg/kg/day	Colistin	Colistate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of subjects with cure or improvement	Cure Improvement Worse Death	up to day 28

Secondary Outcomes

Measure	Description	Time Frame
number of subjects with eradication of causative bacteria	Eradication Persistence Superinfection	up to day 28

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age>18 years
Hospitalized to Siriraj Hospital
Infection with MDR A.baumanii or P.aeruginosa
Nescessary for treatment with Colistin
Patient agrees to participate by giving written informed consent.

Exclusion Criteria:

pregnancy or lactating mother
Colistin or Rifampicin allergy
Active hepatic disease or abnormal liver function test
patient who suspected infection with mycobacterium tuberculosis
patient who can not drug by enteral feeding

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Visanu Thamlikitkul, Professor	Contact	662 419 7000	6626	sivth@mahidol.ac.th
Sunee Thanakhumtorn	Contact	662 419 7000	6616	srstn@mahidol.ac.th

Overall Officials

Name	Affiliation	Role
Sukij Piyasirisilp, MD	Siriraj Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Infectious disease and Tropical Medicine, Department of Medicine, Faculty of Medicine Siriraj Hospital	Recruiting	Bangkoknoi	Bangkok	10700	Thailand

Intervention Browse Module

MeSH Terms

ID	Term
D003091	Colistin
D012293	Rifampin

Ancestor Terms

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

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Browse Branches

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