Safety and Efficacy Study of Adjunctive Rosiglitazone in the Treatment of Uncomplicated Falciparum Malaria

This study has been completed.

Sponsor:

Collaborator:

McLaughlin-Rotman Center for Global Health, University of Toronto

Information provided by:

Mahidol University

ClinicalTrials.gov Identifier:

NCT00149383

First received: September 6, 2005

Last updated: August 22, 2007

Last verified: January 2006

History of Changes

Tracking Information

First Received Date ^ICMJE

September 6, 2005

Last Updated Date

August 22, 2007

Start Date ^ICMJE

December 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Time to clearance (in hours) of parasitemia from blood is recorded [ Time Frame: 5 days ]

Original Primary Outcome Measures ^ICMJE

Time to clearance (in hours) of parasitemia from blood is recorded

Change History

Complete list of historical versions of study NCT00149383 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Time to resolution of fever (in hours) [ Time Frame: 5 days ]
AST/ALT levels (U/L) [ Time Frame: 2 days ]
Capillary blood glucose (mmol/L) [ Time Frame: 2 days ]
Need for ICU admission [ Time Frame: 5 days ]
Tolerability of study drug/placebo as assessed by patient log [ Time Frame: 5 days ]

Original Secondary Outcome Measures ^ICMJE

1) Time to resolution of fever (in hours)
2) AST/ALT levels (U/L)
3) Capillary blood glucose (mmol/L)
4) Need for ICU admission
5) Tolerability of study drug/placebo as assessed by patient log

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy Study of Adjunctive Rosiglitazone in the Treatment of Uncomplicated Falciparum Malaria

Official Title ^ICMJE

A Randomized, Double-Blind, Placebo-Controlled Trial of Rosiglitazone as Adjunctive Therapy for P.Falciparum Infection

Brief Summary

The purpose of this study is to examine the safety, tolerability, and efficacy of adjunctive rosiglitazone in the treatment of uncomplicated P.falciparum malaria.

Detailed Description

Study Rationale: Evidence suggests that if PPAR-RXR agonists (such as rosiglitazone) are used as adjunctive therapy in P. falciparum malaria infections they may increase phagocytic clearance of P. falciparum malaria, modulate deleterious inflammatory responses and decrease sequestration of malaria parasites in vital organs. They may therefore represent a novel immunomodulatory treatment approach for P. falciparum malaria.

Study Objectives: 1) To examine the in vivo effect of rosiglitazone on the rapidity of clearance of P. falciparum parasitemia and fever in patients with non-severe P. falciparum infections 2) To assess the safety and tolerability of adjunctive rosiglitazone treatment in non-severe cases of P. falciparum infection.

Primary Outcomes: Time to clearance of P. falciparum parasitemia

Study Design: Randomized double blind placebo-controlled trial.

Intervention: Standard antimalarial treatment (atovaquone/proguanil) to all patients combined with adjuvant rosiglitazone treatment (8mg per day) or placebo.

Setting: Hospital for Tropical Diseases at Mahidol University, Thailand.

Participants: 140 patients with non-severe P. falciparum infection.

Follow-up: 28 days

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Falciparum Malaria

Intervention ^ICMJE

Drug: Rosiglitazone

Study Arm (s)

Placebo Comparator: 2

Intervention: Drug: Rosiglitazone

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

140

Completion Date

January 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Microscopically confirmed P.falciparum infection
Age >18 years
Able to tolerate oral therapy
Able to give informed consent

Exclusion Criteria:

Fulfillment of WHO criteria for severe/cerebral malaria
Prior treatment with any thiazolidinedione
Allergy to rosiglitazone
History of diabetes mellitus
History of severe/decompensated liver disease
ALT level >2.5 times normal
Current treatment for congestive heart failure
Pregnancy or breastfeeding

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Thailand

Administrative Information

NCT Number ^ICMJE

NCT00149383

Other Study ID Numbers ^ICMJE

033-2004

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Mahidol University

Collaborators ^ICMJE

McLaughlin-Rotman Center for Global Health, University of Toronto

Investigators ^ICMJE

Principal Investigator:

Kevin C Kain, MD, FRCPC

Faculty of Medicine, University of Toronto; McLaughlin-Rotman Center for Global Health, Toronto

Information Provided By

Mahidol University

Verification Date

January 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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