Treatment of Cutaneous Leishmaniasis With Meglumine Antimoniate Versus Meglumine Antimoniate and Allopurinol
Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
Participant gender:
Summary
Background: Cutaneous Leishmaniasis is a worldwide disease, endemic in over 88 countries,
that has shown an increasing incidence over the last many decades. For the last 60 years
antimony compounds are considered the treatment of choice. Though their use is expensive,
cumbersome, has many adverse effects and not effective in all patients, the search for a
better alternative is still going on. Low dose antimony compounds in combination with several
agents have shown promise of reducing adverse effects of antimony compounds without
compromising efficacy. Allopurinol is one such agent which though promising lacks randomized,
controlled trials to prove efficacy. The main objective of this study is to evaluate low dose
sodium stibogluconate in combination with allopurinol and to compare it with high dose sodium
stibogluconate in terms of efficacy and adverse effects.
Methods and design: A multi-center randomized, controlled trial including 620 patients from
endemic areas for Leishmaniasis in Pakistan will be undertaken to assess the research
question. Parasitologically confirmed cutaneous leishmaniasis will be included in the study.
After evaluating the inclusion/exclusion criteria patients will be randomized to receive
either meglumine antimoniate (20 mg/kg/day/intramuscular, till clinical resolution or a
maximum of 28 days) or combination of meglumine antimoniate (10 mg/kg/day intramuscular) and
allopurinol (20 mg/kg/day/oral) till clinical resolution or a maximum of 28 days. During
treatment patients will be admitted to hospital and monitored daily for the presence of
adverse effects. Follow up period will last six months during which patients will visits the
research centers for assessment of healing process at monthly intervals.