title: 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 No subjects were withdrawn from the study due to a treatment-related adverse event.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.affiliation: Tropical Diseases Research Center, Ndola, Zambia.
authors.forename: T Y
authors.initials: TY
authors.lastname: Sukwa
authors.forename: M
authors.initials: M
authors.lastname: Mulenga
authors.forename: N
authors.initials: N
authors.lastname: Chisdaka
authors.forename: N S
authors.initials: NS
authors.lastname: Roskell
authors.forename: T R
authors.initials: TR
authors.lastname: Scott
mesh_terms: D000293:Adolescent; D000328:Adult; D000818:Animals; D000962:Antimalarials / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D053626:Atovaquone; D004311:Double-Blind Method; D004338:Drug Combinations; D006801:Humans; D016778:Malaria, Falciparum / Q000469:parasitology / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D009285:Naphthoquinones / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D018512:Parasitemia / Q000469:parasitology; D010963:Plasmodium falciparum / Q000187:drug effects / Q000302:isolation & purification; D002727:Proguanil / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D015024:Zambia
chemical_list: D000962:Antimalarials; D004338:Drug Combinations; D009285:Naphthoquinones; C109496:atovaquone, proguanil drug combination; D002727:Proguanil; D053626:Atovaquone