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

Mahidol University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Falciparum Malaria

Treatments: Drug: Rosiglitazone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00149383

033-2004

Details and patient eligibility

About

The purpose of this study is to examine the safety, tolerability, and efficacy of adjunctive rosiglitazone in the treatment of uncomplicated P.falciparum malaria.

Full 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

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 2 patient groups, including a placebo group

2

Placebo Comparator group

Treatment:

Drug: Placebo

1

Experimental group

Treatment:

Drug: Rosiglitazone