Low Antimonial Dosage in American Mucosal Leishmaniasis

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oswaldo Cruz Foundation
• Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico; Rio de Janeiro State Research Supporting Foundation (FAPERJ)
• Treatments: Meglumine Antimoniate

Criteria

Inclusion Criteria:

• Mucosal or mucocutaneous leishmaniasis with parasitological diagnosis by one or more of the following methods: direct examination (imprint), histopathology, culture, immunohistochemistry, or PCR.

Exclusion Criteria:

• Women who do not use contraceptives or do it badly

• Pregnant women

• Children under 13 years

• Previous antimonial treatment for LM

• Immunosuppressive therapy (steroids, cancer chemotherapy) or medicines for tuberculosis or leprosy.

• Presence of altered baseline clinical adverse effect level equivalent to > G3

• Presence of altered basal laboratory adverse effect level equivalent to > G2

• Presence of baseline electrocardiographic changes equivalent to an adverse effect level > G4 and / or baseline QTc > 0.46 ms (equivalent to AE level G1)