Comparison of Standard and Alternative Antimonial Dosage in Patients With American Cutaneous Leishmaniasis
Status:
Completed
Trial end date:
2017-12-01
Target enrollment:
Participant gender:
Summary
"Phase III Clinical Trial for American Tegumentary Leishmaniasis: Comparison of Standard and
Alternative Antimonial Dosage in Patients With American Cutaneous Leishmaniasis " 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 dosage scheme of meglumine antimoniate in the
treatment of American tegumentary leishmaniasis (ATL). It is a study with blind evaluation by
the doctors and the responsible for statistical analysis. Patients diagnosed with ATL,
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 (Sb5+) at 20 mg Sb5+ / kg / day, less toxic alternative regimens,
i.e. 5mg Sb5+/kg/day, deserve to be better evaluated. The treatment of ATL must heal skin
lesions and prevent late mucosal lesion development. The indication of high doses of Sb5+ 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 doses (5mg Sb5+ / kg / day) may constitute an effective scheme, achieving cure
rates similar to higher doses, with lower toxicity, ease of implementation and lower cost.
Published studies on efficacy and safety of alternative dosage schemes with meglumine
antimoniate failed to provide conclusive results so far, for various methodological biases.
The need to compare the effectiveness and safety between the standard treatment scheme with
meglumine antimoniate currently recommended in Brazil for the treatment of ATL and an
alternative scheme with low doses 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)