title: Randomized, double-blind, placebo-controlled study of Malarone for malaria prophylaxis in non-immune Colombian soldiers.
abstract: Malarone was compared with placebo in a double-blind, randomized, placebo-controlled trial of prophylaxis of malaria in predominately Plasmodium vivax areas of Colombia. The study population consisted of 180 completely non-immune Colombian soldiers, male, average age 19 years, and average weight 63 kg. Twenty-four subjects were considered unevaluable because of compliance issues, including one Malarone subject (with no detectable drug levels) who became infected with P. vivax. Of the 97 evaluable subjects who received Malarone (250 mg atovaquone plus 100 mg proguanil hydrochloride) daily from 1 day before entering the endemic area to 7 days after leaving the endemic area, none became parasitemic. Of the 46 evaluable placebo subjects, 11 became infected with P. vivax and 2 became infected with Plasmodium falciparum. The protective efficacy of Malarone for all malaria and for P. vivax malaria was 100% (LL 95% CI = 63%) and 100% (LL 95% CI = 58%), respectively, and was 96% if the one case with undetectable blood levels was included. Malarone has high protective efficacy for P. vivax in Colombia.
authors.affiliation: Consorcio de Investigaciones Bioclinicas, Bogota, Colombia. Jaime.Soto@cable.net.co
authors.forename: Jaime
authors.initials: J
authors.lastname: Soto
authors.forename: Julia
authors.initials: J
authors.lastname: Toledo
authors.forename: Magda
authors.initials: M
authors.lastname: Luzz
authors.forename: Patricia
authors.initials: P
authors.lastname: Gutierrez
authors.forename: Jonathan
authors.initials: J
authors.lastname: Berman
authors.forename: Stephane
authors.initials: S
authors.lastname: Duparc
mesh_terms: D000293:Adolescent; D000328:Adult; D000962:Antimalarials / Q000627:therapeutic use*; D053626:Atovaquone; D003105:Colombia; D004311:Double-Blind Method; D004338:Drug Combinations; D006801:Humans; D008288:Malaria / Q000517:prevention & control*; D008297:Male; D008889:Military Personnel; D009285:Naphthoquinones / Q000627:therapeutic use*; D010919:Placebos; D002727:Proguanil / Q000627:therapeutic use*
chemical_list: D000962:Antimalarials; D004338:Drug Combinations; D009285:Naphthoquinones; D010919:Placebos; C109496:atovaquone, proguanil drug combination; D002727:Proguanil; D053626:Atovaquone