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RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF ORAL ARTEMETHER FOR THE PREVENTION OF PATENT SCHISTOSOMA HAEMATOBIUM INFECTIONS

Artemether is an efficacious antimalarial drug that also displays antischistosomal properties. Laboratory studies have found that artemether curtails the development of adult worms of Schistosoma japonicum, S. mansoni, and S. haematobium, and thus prevents morbidity. These findings have been confirmed in clinical trials for the former two parasites; administered orally once every 2–3 weeks, artemether significantly reduced the incidence and intensity of patent infections. Here, we present the first randomized, double-blind, placebo-controlled trial of artemether against S. haematobium, done in a highly endemic area of Côte d’Ivoire. Urine specimens from 440 schoolchildren were examined over 4 consecutive days, followed by two systematic praziquantel treatments 4 weeks apart. S. haematobium-negative children were randomized to receive 6 mg/kg artemether (N = 161) or placebo (N = 161). Medication was administered orally for a total of six doses once every 4 weeks. Adverse events were assessed 72 hours after medication, and perceived illness episodes were monitored throughout the study period. Incidence and intensity of S. haematobium infections, and microhematuria and macrohematuria were assessed 3 weeks after the final dosing. We also monitored malaria parasitemia and treated positive cases with sulfadoxine-pyrimethamine (SP). Oral artemether was well tolerated. The incidence of patent S. haematobium infections in artemether recipients was significantly lower than in placebo recipients (49% versus 65%, protective efficacy: 0.25, 95% CI: 0.08–0.38, P = 0.007). The geometric mean infection intensity in the artemether group was less than half that of the placebo recipients (3.4 versus 7.4 eggs/10 mL urine, P < 0.001). Heavy S. haematobium infections, microhematuria and macrohematuria, and the incidence of malaria parasitemia were all significantly lower in artemether recipients. In conclusion, previous findings of efficacy of artemether against S. japonicum and S. mansoni were confirmed for S. haematobium, although the protective efficacy was considerably lower. These findings enlarge the scope and potential of artemether and further contribute to discussions of its role as an additional tool for integrated schistosomiasis control.

Received March 6, 2002. Accepted for publication July 8, 2002.

Acknowledgments: The authors thank the population and authorities of Taabo, particularly the chief, the school director, and the teachers and schoolchildren for their dedication and excellent collaboration over the last several years. We are grateful to Dr. G. P. Brika, executive director of the national control program against onchocerciasis, trypanosomiasis, schistosomiasis, and dracunculiasis. Thanks are addressed to laboratory technicians K. L. Lohourignon, B. Sosthène, and M. Traoré for their skilled technical assistance, and to Mr. Dupont for help in the laboratory. We are indebted to Dr. T. A. Smith for the randomization and keeping of the code. Kunming Pharmaceutical Corp. kindly provided the study medications.

Financial support: This investigation received financial support from the UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases and the Swiss Tropical Institute. E. K. N’Goran was financially supported by the Swiss Academy of Natural Science and J. Utzinger by the Swiss National Science Foundation and the Centre for Health and Wellbeing at Princeton University.

Reprint requests: Prof. Marcel Tanner, Swiss Tropical Institute, P.O. Box, CH-4002 Basel, Switzerland, Telephone +41 61 284 8283, Fax: +41 271 7951, E-mail: marcel.tanner{at}unibas.ch

Authors’ addresses: Eliézer K. N’Goran, Ahoa Yapi, Nicaise A. N’Guessan, and Silué D. Kigbafori, UFR Biosciences, Université de Cocody, 22 BP 770, Abidjan 22, Côte d’Ivoire; Jürg Utzinger, Office of Population Research, Princeton University, Princeton, N.J. 08544; Henri N. Gnaka, Grandes Endémies de Tiassalé, BP, Tiassalé, Côte d’Ivoire; Silué D. Kigbafori, Christian Lengeler, Jacques Chollet, and Marcel Tanner, Swiss Tropical Institute, P.O. Box, CH-4002 Basel, Switzerland; Xiao Shuhua, Institute of Parasitic Diseases, Chinese Centre for Disease Control and Prevention, Shanghai 200025, China.

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