Low Antimonial Dosage in American Mucosal Leishmaniasis
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
"Phase III clinical trial for mucosal or mucocutaneous leishmaniasis. Equivalence between the
standard and alternative schemes with meglumine antimoniate" has begun in October 2008 at the
Laboratory of Leishmaniasis Surveillance at Evandro Chagas Clinical Research Institute
(IPEC), FIOCRUZ, aiming to compare efficacy and safety of the standard recommended schedule
with an alternative regimen of meglumine antimoniate (MA) in the treatment of mucosal or
mucocutaneous leishmaniasis (ML or MCL)). It is a study with blind evaluation by the doctors
and the responsible for statistical analysis. Patients diagnosed with Ml or MCL, eligible for
the trial, are randomly allocated into one of the schemes with meglumine antimoniate and
monitored before, during and after it. There is no single regimen applicable to all forms of
leishmaniasis around the world. Therapeutic regimens applied to treat people living in other
geographic areas result in mixed outcomes. Ideally, the most appropriate regimens should be
established for each endemic area, based on its efficacy, toxicity, difficulties of
administration and cost. Given the problems and limitations of the use of pentavalent
antimonials at 20 mg / kg / day, a less toxic alternative regimen with 5mg/kg/day, continuous
up to the cure deserves to be better evaluated. Treatment must lead to the healing of mucosal
lesions and prevent late scarring tissues and disabilities development. The indication of
high doses of MA is based on the evidence that there could be induction of resistance with
use of subdoses. However, clinical studies with extended follow-up in Rio de Janeiro have
suggested that regular low MA doses (5mg / kg / day) in a systemic way may constitute an
effective scheme, achieving cure rates similar to higher dose, with lower toxicity, ease of
implementation and lower cost. Published studies on efficacy and safety of alternative
schemes with meglumine antimoniate failed to provide conclusive results, for various
methodological biases. The need to compare the effectiveness and safety between treatment
schemes with meglumine antimoniate currently recommended in Brazil for the treatment of ML or
MCL and an alternative scheme with low dose of antimony is the motive for this study in Rio
de Janeiro.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Oswaldo Cruz Foundation
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico Rio de Janeiro State Research Supporting Foundation (FAPERJ)