Titre du document / Document title
Randomized, parallel placebo-controlled trial of primaquine for malaria prophylaxis in Papua, Indonesia
Auteur(s) / Author(s)
United States Naval Medical Research Unit 2 Clinical Trials Team, ETATS-UNIS
BAIRD J. Kevin
(1) ;
LACY Mark D.
(1) ;
BASRI Hasan
(1) ;
BARCUS Mazie J.
(1) ;
MAGUIRE Jason D.
(1) ;
BANGS Michael J.
(1) ;
GRAMZINSKI Robert
(1) ;
SISMADI Priyanto
(2) ;
KRISIN
(1) ;
LING Judith
(1) ;
WIADY Iwa
(1) ;
KUSUMANINGSIH Marti
(2) ;
JONES Trevor R.
(3) ;
FRYAUFF David J.
(3) ;
HOFFMAN Stephen L.
(4) ;
Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)
(1) Parasitic Diseases Program, US Naval Medical Research Unit 2, Ministry of Health, Republic of Indonesia, Jakarta, INDE
(2) Infectious Disease Research Center, National Institute of Health Research and Development, Ministry of Health, Republic of Indonesia, Jakarta, INDE
(3) Malaria Program, Naval Medical Research Center, Silver Spring, Maryland, ETATS-UNIS
(4) Immunotherapeutics, Celera Genomics, Rockville, Maryland, ETATS-UNIS
Résumé / Abstract
Malaria causes illness or death in unprotected travelers. Primaquine prevents malaria by attacking liver-stage parasites, a property distinguishing it from most chemoprophylactics and obviating 4-week postexposure dosing. A daily adult regimen of 30 mg primaquine prevented malaria caused by Plasmodium falciparum and P. vivax for 20 weeks in 95 of 97 glucose-6-phosphate dehydrogenase (G6PD)-normal Javanese transmigrants in Papua, Indonesia. In comparison, 37 of 149 subjects taking placebo in a parallel trial became parasitemic. The protective efficacy of primaquine against malaria was 93% (95% confidence interval [CI] 71%-98%); against P. falciparum it was 88% (95% C1 48%-97%), and >92% for P. vivax (95% CI >37%-99%). Primaquine was as well tolerated as placebo. Mild methemoglobinemia (mean of 3.4%) returned to normal within 2 weeks. Blood chemistry and hematological parameters revealed no evidence of toxicity. Good safety, tolerance, and efficacy, along with key advantages in dosing requirements, make primaquine an excellent drug for preventing malaria in nonpregnant, G6PD-normal travelers.
Revue / Journal Title
Clinical infectious diseases
ISSN 1058-4838
CODEN CIDIEL
Source / Source
2001, vol. 33, n
o12, pp. 1990-1997 (29 ref.)
Langue / Language
Anglais
Editeur / Publisher
University of Chicago Press, Chicago, IL, ETATS-UNIS
(1992)
(Revue)
Mots-clés anglais / English Keywords
Asia ;
Infection ;
Parasitosis ;
Protozoal disease ;
Clinical trial ;
Human ;
Efficiency ;
Antimalarial ;
Parasiticid ;
Chemoprophylaxis ;
Indonesia ;
Prevention ;
Placebo ;
Malaria ;
Primaquine ;
Mots-clés français / French Keywords
Asie ;
Infection ;
Parasitose ;
Protozoose ;
Essai clinique ;
Homme ;
Efficacité ;
Antipaludique ;
Antiparasitaire ;
Chimioprophylaxie ;
Indonésie ;
Prévention ;
Placebo ;
Paludisme ;
Primaquine ;
Mots-clés espagnols / Spanish Keywords
Asia ;
Infección ;
Parasitosis ;
Protozoosis ;
Ensayo clínico ;
Hombre ;
Eficacia ;
Antipalúdico ;
Antiparasitario ;
Quimioprofilaxis ;
Indonesia ;
Prevención ;
Placebo ;
Paludismo ;
Primaquina ;
Localisation / Location
INIST-CNRS, Cote INIST : 18407, 35400009468340.0050
Nº notice refdoc (ud4) : 13393423
