RANDOMIZED CONTROLLED TRIAL OF AMINOSIDINE (PAROMOMYCIN) UPSILON-SODIUM STIBOGLUCONATE FOR TREATING VISCERAL LEISHMANIASIS IN NORTH BIHAR, INDIA

Objectives: To assess the efficacy and tolerability of aminosidine com pared with sodium stibogluconate for treating visceral leishmaniasis. Design: Randomised, unblinded, controlled trial with 180 day follow up . Setting: Kala-Azar Research Centre, Brahmpura, Muzaffarpur, Bihar, I ndia. Subjects: People of either sex aged 6-50 years with symptoms and signs suggestive of visceral leishmaniasis (fever, loss of appetite, enlarged spleen). with leishmania amastigotes detected in Giemsa stain ed aspirates of spleen or bone marrow. Interventions: Aminosidine at t hree daily doses (12, 16, and 20 mg/kg) for 21 days and sodium stibogl uconate 20 mg/kg/day for 30 days. Main outcome measures: Laboratory me asures of efficacy: parasite count, haemoglobin concentration, white c ell count platelet count, serum albumin concentration. Clinical measur es of efficacy: spleen size, fever, body weight, and liver size. Measu res of safety: liver and renal function tests, reports of adverse even ts. Results: Of the 120 patients enrolled (30 per treatment arm), 119 completed treatment and follow up. Cure at end of follow up was achiev ed in 23 (77%), 28 (93%), and 29 (97%) patients treated with 12, 16, a nd 20 mg aminosidine/kg/day respectively, and in 19 (63%) patients giv en sodium stibogluconate. At 16 and 20 mg/kg/day, aminosidine was sign ificantly more active than sodium stibogluconate in both clinical and laboratory measures of efficacy. No significant clinical or laboratory toxicity occurred in any treatment group. Conclusions: A 21 day cours e of aminosidine 16 or 20 mg/kg/day should be considered as first line treatment for visceral leishmaniasis in Bihar.