EPIDEMIC VISCERAL LEISHMANIASIS IN SUDAN - A RANDOMIZED TRIAL OF AMINOSIDINE PLUS SODIUM STIBOGLUCONATE VERSUS SODIUM STIBOGLUCONATE ALONE

In a comparative trial of treatment in southern Sudan, visceral leishmaniasis was diagnosed by the following symptoms: fever for >1 month, splenomegaly, and antileishmanial direct agglutination test (DAT) titer of greater-than-or-equal-to 1:25,600. Patients (200) were randomized to receive sodium stibogluconate (Sb(v)) at 20 mg/kg/day for 30 days (groups S, n = 99) or Sb(v) at 20 mg/kg/day plus aminosidine at 15 mg/kg/day for 17 days (group AS, n = 101). Of 192 patients who had spleens or lymph nodes aspirated at entry, 134 (70%) were positive for parasites. During treatment, 7% in group S and 4% in group AS died. All 184 patients who completed treatment were clinically cured. At days 15-17, microscopy of aspirates showed that 57 (95%) of 60 in group AS were negative for parasites compared with 47 (81%) of 58 in group S (P = .018). At day 30, 57 (93.4%) of 61 group S aspirates were negative.