Safety and Efficacy Study of Adjunctive Rosiglitazone in the Treatment of Uncomplicated Falciparum Malaria
|ClinicalTrials.gov Identifier: NCT00149383|
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : April 13, 2015
|Condition or disease||Intervention/treatment||Phase|
|Falciparum Malaria||Drug: Rosiglitazone Drug: Placebo||Phase 1 Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-blind, Placebo-controlled Trial of Rosiglitazone as Adjunctive Therapy for P.Falciparum Infection|
|Study Start Date :||December 2004|
|Actual Primary Completion Date :||November 2005|
|Actual Study Completion Date :||January 2006|
|Placebo Comparator: 2||Drug: Placebo|
|Experimental: 1||Drug: Rosiglitazone|
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|