Clinical Trial: Low Antimonial Dosage in American Mucosal Leishmaniasis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Phase III Clinical Trial for Mucosal or Mucocutaneous Leishmaniasis. Comparison Between the Standard and Alternative Antimonial Schemes
Brief 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 variou
Detailed Summary:
- Introduction. Pentavalent antimonials are first line drugs for the treatment of leishmaniasis. WHO and Brazilian Ministry of Health recommend treating patients with mucosal (ML) or mucocutaneous leishmaniasis (MCL) with doses of 20mg/kg/day, intramuscularly or intravenously, for a period of three to four weeks. In the Reference Centre on Leishmaniasis - IPEC - FIOCRUZ, the dose of 5mg/kg/day IM has been effective and well tolerated in the treatment. ML is treated for 30 continuous or intermittent days, in series of 10 days interspersed with periods of 10 days without medication, up to 12 series of treatment (120 medication days), with a lower incidence of adverse effects and lower treatment dropout rates. The evolution of the lesions is usually similar to that observed with continuous treatment. In all cases patients should be monitored with clinical examination, electrocardiogram, blood count, liver function, renal and pancreatic tests. Some side effects can be observed, although they not necessarily lead to discontinuation of treatment: arthralgia, myalgia, anorexia, abdominal pain, rash, fever, headache, edema, and herpes zoster. Electrocardiographic abnormalities most frequent are heart rhythm and ventricular repolarization disturbances: flattening or inversion of T wave and corrected QT space widening.
- Background: Ideally, the most appropriate antimoniate therapeutic regimens should be established for each endemic area, based on their efficacy and toxicity, without ignoring the difficulties of administration and cost. The treatment of ML or MCL must achieve the healing of mucosal lesions and prevention of severe scarring of mucosal tissues and consequent disabilities. The recognition, recommendation and acceptance of new regimens should be preceded by demonstration of their superiority to currently recommended treatments. We aim to compare the effect
Sponsor: Oswaldo Cruz Foundation
Current Primary Outcome: Efficacy of meglumine antimoniate in the treatment of mucosal leishmaniasis [ Time Frame: 6 years ]
This study is designed to evaluate the efficacy of high and low doses of meglumine antimoniate in the treatment of mucosal or mucocutaneous leishmaniasis.
Original Primary Outcome: Same as current
Current Secondary Outcome: Safety of meglumine antimoniate in the treatment of mucosal leishmaniasis [ Time Frame: 6 years ]
This study is designed to evaluate the safety of hig and low doses of meglumine antimoniate in the treatment of mucosal or mucocutaneous leishmaniasis.
Original Secondary Outcome: Same as current
Information By: Oswaldo Cruz Foundation
Dates:
Date Received: February 20, 2011
Date Started: October 2008
Date Completion: December 2016
Last Updated: May 30, 2016
Last Verified: May 2016
