A randomized, double-blind, placebo-controlled field trial to determine the efficacy and safety of Malarone (atovaquone/proguanil) for the prophylaxis of malaria in Zambia.

Abstract

Malaria poses a major health risk to people who are exposed to infection in malaria-endemic areas. A randomized, double-blind, placebo-controlled study was conducted to determine the efficacy and safety of Malarone (250 mg of atovaquone/100 mg of proguanil hydrochloride per tablet) for the chemoprophylaxis of Plasmodium falciparum malaria in Zambia. Adult volunteers received a three-day treatment course of Malarone to eliminate pre-existing parasitemia and were then immediately randomized to treatment with either one Malarone tablet daily (n = 136), or one placebo tablet daily (n = 138) for at least 10 weeks. Malaria blood smears were prepared on a weekly basis and a failure of chemoprophylaxis was defined as any subject who had a positive blood smear, or who withdrew from the study due to a treatment-related adverse event. The prophylaxis success rates in the Malarone and placebo groups were 98% and 63%, respectively (P < 0.001). The most commonly reported adverse events with at least a possible causal relationship to study medication were headache and abdominal pain, which occurred with a higher incidence in the placebo group. No subjects were withdrawn from the study due to a treatment-related adverse event. Thus, Malarone appears to have an excellent safety and efficacy profile for the chemoprophylaxis of P. falciparum infection.

• Authors: T Y Sukwa, M Mulenga, N Chisdaka, N S Roskell, T R Scott
• Journal: The American journal of tropical medicine and hygiene (Am J Trop Med Hyg) Vol. 60 Issue 4 Pg. 521-5 (Apr 1999) ISSN: 0002-9637 [Print] United States
• PMID: 10348223 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antimalarials
• Drug Combinations
• Naphthoquinones
• atovaquone, proguanil drug combination
• Proguanil
• Atovaquone

Topics

• Adolescent
• Adult
• Animals
• Antimalarials (adverse effects, blood, therapeutic use)
• Atovaquone
• Double-Blind Method
• Drug Combinations
• Humans
• Malaria, Falciparum (parasitology, prevention & control)
• Male
• Middle Aged
• Naphthoquinones (adverse effects, blood, therapeutic use)
• Parasitemia (parasitology)
• Plasmodium falciparum (drug effects, isolation & purification)
• Proguanil (adverse effects, blood, therapeutic use)
• Zambia