Terence T Tafatatha1, Bagrey M Ngwira2, Miriam Taegtmeyer3, Amos J Phiri4, Trevor P Wilson2, Louis G Banda4, Wilson N Piston4, Olivier Koole2, John Horton5, Neil French6. 1. Karonga Prevention Study, Chilumba, Karonga district, Malawi Centre for Neglected Tropical Diseases, Liverpool School of Tropical Medicine, Liverpool, UK ttafatatha@yahoo.com. 2. Karonga Prevention Study, Chilumba, Karonga district, Malawi London School of Hygiene & Tropical Medicine, London, UK. 3. Department of International Public Health, Liverpool School of Tropical Medicine, Liverpool, UK. 4. Karonga Prevention Study, Chilumba, Karonga district, Malawi. 5. Tropical Projects, Hitchin, UK. 6. Karonga Prevention Study, Chilumba, Karonga district, Malawi Institute of Infection and Global Health, University of Liverpool, Liverpool, UK.
Abstract
BACKGROUND: In Africa, albendazole and ivermectin are currently used in combination for annual mass drug administration (MDA) for lymphatic filariasis (LF) elimination. Rapid and sustained clearance is desirable for public health impact and elimination of LF. Increasing the dose and/or frequency of albendazole and ivermectin treatment may be more effective in clearing microfilariae than standard MDA. METHODS: We conducted a randomised controlled open label trial in northern Malawi comparing three modified treatment groups to standard dosage of ivermectin and albendazole in adults with confirmed circulating LF antigen and microfilaria. Participants were followed-up every 6 months for 2 years for repeat microfilarial counts and safety assessments. RESULTS: A total of 1851 adults were screened and 70 with microfilarial counts >80 microfilariae/ml were randomised. All treatment groups achieved a significant reduction of microfilariae levels by 12- and 24-months of follow-up. Doubling the standard dose and administering it twice yearly showed a non-significant tendency towards faster and more complete clearance. There were no serious adverse reactions. CONCLUSIONS: In this small study, all regimens effectively cleared microfilaria. Standard treatment may be adequate in settings like Malawi but not in all endemic settings and larger studies are required to demonstrate benefit of higher dosages. [ClinicalTrials.gov identifier: NCT01213576].
RCT Entities:
BACKGROUND: In Africa, albendazole and ivermectin are currently used in combination for annual mass drug administration (MDA) for lymphatic filariasis (LF) elimination. Rapid and sustained clearance is desirable for public health impact and elimination of LF. Increasing the dose and/or frequency of albendazole and ivermectin treatment may be more effective in clearing microfilariae than standard MDA. METHODS: We conducted a randomised controlled open label trial in northern Malawi comparing three modified treatment groups to standard dosage of ivermectin and albendazole in adults with confirmed circulating LF antigen and microfilaria. Participants were followed-up every 6 months for 2 years for repeat microfilarial counts and safety assessments. RESULTS: A total of 1851 adults were screened and 70 with microfilarial counts >80 microfilariae/ml were randomised. All treatment groups achieved a significant reduction of microfilariae levels by 12- and 24-months of follow-up. Doubling the standard dose and administering it twice yearly showed a non-significant tendency towards faster and more complete clearance. There were no serious adverse reactions. CONCLUSIONS: In this small study, all regimens effectively cleared microfilaria. Standard treatment may be adequate in settings like Malawi but not in all endemic settings and larger studies are required to demonstrate benefit of higher dosages. [ClinicalTrials.gov identifier: NCT01213576].
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