Epidemic visceral leishmaniasis in Sudan: a randomized trial of aminosidine plus sodium stibogluconate versus sodium stibogluconate alone

J Infect Dis. 1993 Sep;168(3):715-20. doi: 10.1093/infdis/168.3.715.

Abstract

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 > or = 1:25,600. Patients (200) were randomized to receive sodium stibogluconate (Sbv) at 20 mg/kg/day for 30 days (groups S, n = 99) or Sbv 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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Antimony Sodium Gluconate / therapeutic use*
  • Child
  • Child, Preschool
  • Disease Outbreaks
  • Drug Therapy, Combination
  • Female
  • Giardiasis / drug therapy
  • Humans
  • Infant
  • Leishmaniasis, Visceral / complications
  • Leishmaniasis, Visceral / drug therapy*
  • Malaria / drug therapy
  • Male
  • Middle Aged
  • Nutrition Disorders / complications
  • Paromomycin / therapeutic use*
  • Pregnancy
  • Sudan / epidemiology
  • Weight Loss

Substances

  • Paromomycin
  • Antimony Sodium Gluconate