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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
- 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.
Abstract
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.
- Copyright ©2004 by the American College of Physicians
