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Primaquine Prophylaxis against Malaria in Nonimmune Colombian Soldiers: Efficacy and Toxicity: A Randomized, Double-Blind, Placebo-Controlled Trial

Jaime Soto, MD; Julia Toledo, MD; Maria Rodriquez, Med Tech; Jorge Sanchez, Med Tech; Ricardo Herrera, MD; Julio Padilla, MD; and Jonathan Berman, MD, PhD
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From Universidad Militar Nueva Granada, Consorcio de Investigaciones Bioclinicas, Direccion de Sanidad Ejercito, and Ministerio de Salud, Bogota, Colombia; and Walter Reed Army Institute of Research, Washington, D.C. Acknowledgments: The authors thank Dr. Ohrt for critical review of the manuscript. Grant Support: By grant 95-01 from the AB Foundation for Medical Research. Requests for Reprints: Jaime Soto, MD, Universidad Militar Nueva Granada, Calle 100 con Cra 11, Santafe de Bogota, DC, Colombia. Current Author Addresses: Dr. Soto: Universidad Militar Nueva Granada, Calle 100 con Cra 11, Santafe de Bogota, DC, Colombia. Dr. Toledo: Consorcio de Investigaciones Bioclinicas CIBIC, Calle 60 A # 5-54, Oficina 201, Santafe de Bogota, DC, Colombia. Ms. Rodriguez: Direccion de Sanidad Ejercito, Avenida 7 con Calle 53, Santafe de Bogota, DC, Colombia.

Copyright ©2004 by the American College of Physicians

Ann Intern Med. 1998;129(3):241-244. doi:10.7326/0003-4819-129-3-199808010-00013
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Background: Primaquine had a prophylactic efficacy of 90% to 95% against infection with Plasmodium falciparum and P. vivax in Indonesian settlers.

Objective: To evaluate the efficacy of primaquine prophylaxis for protecting nonimmune persons from malaria.

Design: Randomized, double-blind, placebo-controlled field study.

Setting: A malaria-endemic area in Colombia.

Patients: 176 healthy, young, nonimmune adult male soldiers.

Intervention: Primaquine, 30 mg/d, or matching placebo during 15 weeks of patrol in the endemic area and 1 week afterward.

Measurements: Symptomatic parasitemia was determined over the 16-week intervention period and for 3 weeks in base camp.

Results: Protective efficacy in the primaquine group (122 participants) was 89% (95% CI, 75% to 96%) against all types of malaria, 94% (CI, 78% to 99%) against P. falciparum malaria, and 85% (CI, 57% to 95%) against P. vivax malaria. Six primaquine recipients had mild to moderate gastrointestinal distress, and three had severe distress.

Conclusions: For prophylaxis against P. falciparum malaria, primaquine has an efficacy and toxicity competitive with those of standard agents. A potential advantage of primaquine is that prophylaxis may be discontinued 1 week after the recipient has left the endemic area.





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