The purpose of this study is to examine the safety, tolerability, and efficacy of adjunctive rosiglitazone in the treatment of uncomplicated P.falciparum malaria...
Date First Received: September 6, 2005
Last Updated: August 22, 2007
Verified by: Mahidol University, January 2006
Clinical Trial Phase: Phase 1/Phase 2 | Start Date: December 2004
Overall Status: Completed
Estimated Enrollment: 140
Brief Summary
Official Title: “A Randomized, Double-Blind, Placebo-Controlled Trial of Rosiglitazone as Adjunctive Therapy for P.Falciparum Infection”
Condition Keyword(s):
Intervention(s):
The purpose of this study is to examine the safety, tolerability, and efficacy of adjunctive rosiglitazone in the treatment of uncomplicated P.falciparum malaria.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Detailed Clinical Trial 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
Intervention(s) in this Clinical Trial
- Drug: Rosiglitazone
Arms, Groups and Cohorts in this Clinical Trial
- Placebo Comparator: 2
Outcome Measures for this Clinical Trial
Primary Measures
- Time to clearance (in hours) of parasitemia from blood is recorded
- Time Frame: 5 days
- Time Frame: 5 days
Secondary Measures
- Time to resolution of fever (in hours)
- Time Frame: 5 days
- Time Frame: 5 days
- AST/ALT levels (U/L)
- Time Frame: 2 days
- Time Frame: 2 days
- Capillary blood glucose (mmol/L)
- Time Frame: 2 days
- Time Frame: 2 days
- Need for ICU admission
- Time Frame: 5 days
- Time Frame: 5 days
- Tolerability of study drug/placebo as assessed by patient log
- Time Frame: 5 days
- Time Frame: 5 days
Criteria for Participation in this Clinical Trial
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 Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Mahidol University
Overall Clinical Trial Officials and Contacts
Kevin C Kain, MD, FRCPC Principal Investigator Faculty of Medicine, University of Toronto; McLaughlin-Rotman Center for Global Health, Toronto
Related Publications
References
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Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00149383
Study ID Number: 033-2004
ClinicalTrials.gov Identifier: NCT00149383
Health Authority: Thailand: Ethical Committee
Mahidol University, Faculty of Tropical Medicine
McLaughlin Centre for Molecular Medicine, McLaughlin-Rotman Center for Global Health
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
