Clinical Trial: Comparison of Standard and Alternative Antimonial Dosage in Patients With American Cutaneous Leishmaniasis
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Phase III Clinical Trial for American Tegumentary Leishmaniasis: Comparison of Standard and Alternative Antimonial Dosage in Patients With American Cutaneous Leishmaniasis
Brief 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 t
Detailed Summary:
- Introduction. Pentavalent antimonials are first line drugs for the treatment of leishmaniasis. WHO and Brazilian Ministry of Health recommend treating patients with cutaneous leishmaniasis (CL) with doses of 20mg/kg/day, IM or IV, for 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 of CL. CL is treated for 30 days, with a lower incidence of adverse effects and lower treatment dropout rates. In all cases patients should be monitored with clinical examination, electrocardiogram (EKG), blood count, liver, renal and pancreatic function tests. Some side effects can be observed, although they not necessarily lead to discontinuation of treatment. EKG most frequent abnormalities are heart rhythm and disturbances of ventricular repolarization: flattening or inversion of T wave and adjusted QT space widening.
- Background: Ideally, the most appropriate antimoniate therapeutic regimens should be established for each area, based on their efficacy and toxicity, without ignoring the difficulties of administration and cost. The treatment of CL must achieve healing of skin lesions and prevention of late mucosal involvement. 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 effectiveness and safety among treatment schemes with meglumine antimoniate currently recommended in Brazil for the treatment of CL and the alternative scheme with low dose of antimony.
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Objectives. 3.1. General Objective. To compare the effectiveness and safety of 20 days of 20 mg/kg/day meglumine antimoniate with 30 days of 5 mg/kg/day meglumine antimoniate in the treatment of patients
Sponsor: Oswaldo Cruz Foundation
Current Primary Outcome: Effectiveness of meglumine antimoniate treatment [ Time Frame: 6 years ]
To compare the effectiveness of meglumine antimoniate at a dose of 5 mg or 20 mg Sb5+ / kg / day in the treatment of patients with cutaneous leishmaniasis.
Original Primary Outcome: Effectiveness of meglumine antimoniate treatment [ Time Frame: 6 years ]
To compare the effectiveness of meglumine antimoniate at a dose of 5 mg or 20 mg Sb5+ / kg / day, continuous or intermittent, in the treatment of patients with cutaneous leishmaniasis.
Current Secondary Outcome: Safety of meglumine antimoniate treatment [ Time Frame: 6 years ]
To compare the safety of meglumine antimoniate at a dose of 5 mg or 20 mg Sb5+ / kg / day in the treatment of patients with cutaneous leishmaniasis.
Original Secondary Outcome: Safety of meglumine antimoniate treatment [ Time Frame: 6 years ]
To compare the safety of meglumine antimoniate at a dose of 5 mg or 20 mg Sb5+ / kg / day, continuous or intermittent, in the treatment of patients with cutaneous leishmaniasis.
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
