Status:
COMPLETED
Safety and Efficacy Study of Adjunctive Rosiglitazone in the Treatment of Uncomplicated Falciparum Malaria
Lead Sponsor:
Mahidol University
Collaborating Sponsors:
McLaughlin-Rotman Center for Global Health, University of Toronto
Conditions:
Falciparum Malaria
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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. fal...
Eligibility Criteria
Inclusion
- Microscopically confirmed P.falciparum infection
- Age \>18 years
- Able to tolerate oral therapy
- Able to give informed consent
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2006
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00149383
Start Date
December 1 2004
End Date
January 1 2006
Last Update
April 13 2015
Active Locations (1)
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1
Faculty of Tropical Medicine, Mahidol University
Bangkok, Thailand, 10400