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To assist the Peruvian Ministry of Health in modifying the malaria treatment policy for their north Pacific coastal region, we conducted an in vivo efficacy trial of sulfadoxine-pyrimethamine (SP) and SP plus artesunate (SP-AS) for the treatment for uncomplicated Plasmodium falciparum infections. A total of 197 patients were randomized to therapy with either SP (25 mg/kg of the sulfadoxine component in a single dose on day 0) or a combination of SP plus AS (4 mg/kg on days 0, 1, and 2) and were followed for 28 days for symptoms and recurrence of parasitemia. No statistically significant differences between the two groups were observed on enrollment with respect to age, sex, history of malaria, or geometric mean parasite density. A total of 185 subjects completed the 28-day follow-up. Of the 91 subjects treated with SP alone, two had recurrences of parasitemia on day 7 and one on day 21. Of the 94 subjects treated with SP-AS, one had a recurrence of parasitemia on day 21. Fever and asexual parasite density decreased significantly more rapidly and the proportion of patients with gametocytemia on days 3–28 was significantly lower in subjects treated with combination therapy than in those who received SP alone. No severe adverse drug reactions were observed; however, self-limited rash and pruritis were significantly more common and an exacerbation of nausea, vomiting, and abdominal pain were observed significantly more frequently among patients who had received SP-AS. These results have contributed to a National Malaria Control Program decision to change to SP-AS combination therapy as the first-line treatment for uncomplicated P. falciparum malaria in northern coastal Peru in November 2001, making Peru the first country in the Americas to recommend this combination therapy.
Received July 17, 2003. Accepted for publication January 22, 2004.
Acknowledgments: We thank Dr. José Luis Suárez, who acted as medical monitor for the study. We also thank Edith Guerrero, Enrique Javier Pacherrez, and the staff of the Bellavista and Querecotillo Health Centers for their assistance with the enrollment, treatment, and follow-up of patients. The microscopic examinations were performed by Marcelino Mendoza and Angel Távara. Richard Vera carried out the hematologic and biochemical examinations. Statistical analyses were 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, Laura Ylquimiche, Ygor Hermenegildo, Eduardo Falconí, César Cabezas, Nancy Arróspide, and Sonia Gutierrez, Instituto Nacional de Salud Lima, Peru. Ana Maria Palacios, Dirección Sub-Regional de Salud Piura II, Ministerio de Salud, Sullana, Peru. Trenton K. Ruebush II, Division of Parasitic Diseases, Centers for Disease Control and Prevention, 4770 Buford Highway, Mailstop F-22, Atlanta, GA 30341, Fax: 770-488-4203, E-mail: tkr1{at}cdc.gov.
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  J. Cairo, S. Durand, W. Marquino, C. Cabezas, A. Lachira, F. Quintana, W. Vegas, T. K. Ruebush II, G. Utz, and D. J. Bacon Surveillance for Adverse Drug Reactions to Combination Antimalarial Therapy with Sulfadoxine-Pyrimethamine plus Artesunate in Peru Am J Trop Med Hyg, July 1, 2008; 79(1): 42 - 44. [Abstract] [Full Text] [PDF]
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