Safety and Efficacy Study of Adjunctive Rosiglitazone in the Treatment of Uncomplicated Falciparum Malaria
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-blind, Placebo-controlled Trial of Rosiglitazone as Adjunctive Therapy for P.Falciparum Infection|
- Time to clearance (in hours) of parasitemia from blood is recorded [ Time Frame: 5 days ]
- 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 ]
|Study Start Date:||December 2004|
|Study Completion Date:||January 2006|
|Primary Completion Date:||November 2005 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00149383
|Faculty of Tropical Medicine, Mahidol University|
|Bangkok, Thailand, 10400|
|Principal Investigator:||Kevin C Kain, MD, FRCPC||Faculty of Medicine, University of Toronto; McLaughlin-Rotman Center for Global Health, Toronto|