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Randomised controlled trial of aminosidine (paromomycin) v sodium stibogluconate for treating visceral leishmaniasis in North Bihar, India.

AbstractOBJECTIVES:
To assess the efficacy and tolerability of aminosidine compared 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, India.
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 stained aspirates of spleen or bone marrow.
INTERVENTIONS:
Aminosidine at three daily doses (12, 16, and 20 mg/kg) for 21 days and sodium stibogluconate 20 mg/kg/day for 30 days.
MAIN OUTCOME MEASURES:
Laboratory measures of efficacy: parasite count, haemoglobin concentration, white cell count, platelet count, serum albumin concentration. Clinical measures of efficacy: spleen size, fever, body weight, and liver size. Measures of safety: liver and renal function tests, reports of adverse events.
RESULTS:
Of the 120 patients enrolled (30 per treatment arm), 119 completed treatment and follow up. Cure at end of follow up was achieved in 23 (77%), 28 (93%), and 29 (97%) patients treated with 12, 16, and 20 mg aminosidine/kg/day respectively, and in 19 (63%) patients given sodium stibogluconate. At 16 and 20 mg/kg/day, aminosidine was significantly 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 course of aminosidine 16 or 20 mg/kg/day should be considered as first line treatment for visceral leishmaniasis in Bihar.
AuthorsT K Jha, P Olliaro, C P Thakur, T P Kanyok, B L Singhania, I J Singh, N K Singh, S Akhoury, S Jha
JournalBMJ (Clinical research ed.) (BMJ) Vol. 316 Issue 7139 Pg. 1200-5 (Apr 18 1998) ISSN: 0959-8138 [Print] England
PMID9583927 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Anti-Bacterial Agents
  • Schistosomicides
  • Paromomycin
  • Antimony Sodium Gluconate
Topics
  • Adolescent
  • Adult
  • Anti-Bacterial Agents (adverse effects, therapeutic use)
  • Antimony Sodium Gluconate (adverse effects, therapeutic use)
  • Child
  • Dose-Response Relationship, Drug
  • Humans
  • Injections, Intramuscular
  • Leishmaniasis, Visceral (drug therapy)
  • Middle Aged
  • Paromomycin (adverse effects, therapeutic use)
  • Risk Assessment
  • Schistosomicides (adverse effects, therapeutic use)
  • Treatment Outcome

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