NCT00149383

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Falciparum Malaria

Interventions

Type	Name	Description
DRUG	Rosiglitazone
DRUG	Placebo

Timeline

• Start date: 2004-12-01
• Primary completion: 2005-11-01
• Completion: 2006-01-01
• First posted: 2005-09-08
• Last updated: 2015-04-13

Locations

1 site across 1 country: Thailand