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In the Amazon Basin of Peru, more than 50% of patients with uncomplicated Plasmodium falciparum malaria fail to respond to treatment with chloroquine or sulfadoxine-pyrimethamine. To assist the National Malaria Control Program in identifying an alternative first-line therapy for this region, we conducted a trial of the safety and efficacy of mefloquine (MQ) compared with mefloquine-artesunate (MQ-AS) combination therapy. Patients with uncomplicated P. falciparum infections between the ages of 5 and 50 years were randomly assigned to be treated with either MQ (15 mg/kg in a single oral dose) or MQ (15 mg/kg) plus AS (4 mg/kg/day for three days). A total of 98 patients were enrolled and followed for 28 days. None of the 47 patients who received MQ alone or the 51 patients who received MQ-AS combination therapy had recurrences of parasitemia during the 28-day follow-up period. Asexual parasite densities decreased significantly more rapidly and the proportion of patients with gametocytes was significantly lower on days 3–21 in the MQ-AS group than in patients treated with MQ alone. All patients tolerated the medication well. Based on the results of this study and with the objective of slowing the development of resistance, the Peruvian Ministry of Health has decided to revise its malaria treatment policy and recommend combination therapy with MQ-AS as the new first-line treatment of uncomplicated P. falciparum malaria in the Amazon region.
Received March 5, 2002. Accepted for publication December 12, 2002.
Acknowledgments: Dr. Carlos Vidal acted as medical monitor for the study. We thank Ever Alvarez, Anibal Sanchez, and Dolores Rimarachin for the microscopic diagnoses and Ernesto Arevelo, Rosario Pinedo, Gonzalo Reátegui, and the staff of the Moronacocha Health Center and the Hospital de Apoyo Iquitos for their assistance with the enrollment, treatment, and follow-up of patients. The statistical analysis was carried out by Christian Bautista.
Financial support: This study was supported by the U.S. Agency for International Development–Government of Peru VIGIA Project "Addressing Threats of Emerging and Re-Emerging Infectious Diseases" (Activity 527-0391) and the U.S. Naval Medical Research and Development Command, National Naval Medical Center (Bethesda, MD), Work Unit No. 847705 82000 25GB B0016 GEIS Lima.
Disclaimer: The opinions and assertions contained herein are the private ones of the writers and are not to be construed as official or as reflecting the views of the Navy Department or the naval service at large.
Authors’ addresses: Wilmer Marquiño, María Huilca, Eduardo Falconí, and César Cabezas, Instituto Nacional de Salud, Capac Yupanqui 1400, Jesus Maria 11, Lima, Peru. Carlos Calampa and Rubén Naupay, Dirección Regional de Salud Loreto, Avenida 28 de Julio S/N, Punchana, Iquitos, Peru. Trenton K. Ruebush II, U.S. Naval Medical Research Center Detachment, Unit 3800, APO AA 34031.
Reprint requests: Trenton K. Ruebush II, U.S. Naval Medical Research Center Detachment, Unit 3800, APO AA 34031, Telephone: 51-1-561-2733, Fax: 51-1-561-3042, E-mail: ruebush{at}namrid.sld.pe
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