Comparison of Low and High Antimonial Dosage in American Cutaneous Leishmaniasis
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Purpose
"Phase III clinical trial for American tegumentary 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 alternative regimens 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, continuous or intermittent, with 5mg Sb5+/kg/day, and intralesional therapy with antimony 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) in a systemic way as well as intralesional therapy with meglumine antimoniate may constitute effective schemes, achieving cure rates similar to higher doses, 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 ATL and alternative schemes with low doses of antimony is the motive for this study in Rio de Janeiro.
| Condition | Intervention | Phase |
|---|---|---|
|
Cutaneous Leishmaniasis |
Drug: Meglumine antimoniate |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
| Official Title: | Phase III Clinical Trial for American Tegumentary Leishmaniasis: Equivalence Between the Standard and Alternative Schemes With Meglumine Antimoniate |
- Effectiveness of meglumine antimoniate treatment [ Time Frame: 6 years ] [ Designated as safety issue: No ]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.
- Safety of meglumine antimoniate treatment [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 340 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: High continuous dose
High continuous dose: 20 mg/kg/day for 20 continuous days
|
Drug: Meglumine antimoniate
Meglumine antimoniate is stored and ministered under actual conditions employed by health services in Brazil. Each patient will be included in one of four treatment groups with meglumine antimoniate IM:
Other Name: Glucantime
|
|
Active Comparator: High intermittent dose
High intermittent dose: 20 mg/kg/day for two series of 10 days, interspersed with 10 days without medication
|
Drug: Meglumine antimoniate
Meglumine antimoniate is stored and ministered under actual conditions employed by health services in Brazil. Each patient will be included in one of four treatment groups with meglumine antimoniate IM:
Other Name: Glucantime
|
|
Active Comparator: Low continuous dose
Low continuous dose: 5 mg/kg/day for 30 continuous days
|
Drug: Meglumine antimoniate
Meglumine antimoniate is stored and ministered under actual conditions employed by health services in Brazil. Each patient will be included in one of four treatment groups with meglumine antimoniate IM:
Other Name: Glucantime
|
|
Active Comparator: Low intermittent dose
Low intermittent dose 5 mg/kg/day in 3 series of 10 days interspersed with 10 days interval.
|
Drug: Meglumine antimoniate
Meglumine antimoniate is stored and ministered under actual conditions employed by health services in Brazil. Each patient will be included in one of four treatment groups with meglumine antimoniate IM:
Other Name: Glucantime
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Eligibility Criteria.
Inclusion criteria:
- Cutaneous leishmaniasis with parasitological diagnosis by one or more of the following methods: direct examination (scraping or imprint), histopathology, culture, immunohistochemistry, or PCR.
- History of exposure in an endemic area of Rio de Janeiro
- Absence of prior treatment with meglumine antimoniate
Exclusion criteria:
- women who do not use contraceptives or do it inadequately
- pregnant
- under 13
- prior treatment with meglumine antimoniate
- use of immunosuppressive therapy (steroids, cancer chemotherapy) or medicines for tuberculosis or leprosy.
- presence of changes in baseline clinical adverse effect level equivalent to> G3
- presence of changes in baseline 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 AS level G1).
Contacts and Locations| Contact: Armando O Schubach, MD., PhD | (55)(21)38659673 | armando.schubach@ipec.fiocruz.br |
| Contact: Maria Inês F Pimentel, MD., PhD | (55)(21)38659541 | vigileish@ipec.fiocruz.br |
| Brazil | |
| Oswaldo Cruz Foundation - IPEC/FIOCRUZ | Recruiting |
| Rio de Janeiro, Brazil | |
| Study Director: | Armando O. Schubach, MD, PhD | IPEC/FIOCRUZ |
More Information
Additional Information:
Publications:
| Responsible Party: | ASchubach, Senior Researcher, Oswaldo Cruz Foundation |
| ClinicalTrials.gov Identifier: | NCT01301924 History of Changes |
| Other Study ID Numbers: | low dosage CL |
| Study First Received: | February 20, 2011 |
| Last Updated: | March 26, 2012 |
| Health Authority: | Brazil: Ministry of Health Brazil: Ethics Committee |
Keywords provided by Oswaldo Cruz Foundation:
|
Leishmaniasis Cutaneous Leishmania braziliensis Meglumine Antimoniate Treatment Effectiveness Controlled Clinical Trials, Randomized |
Additional relevant MeSH terms:
|
Leishmaniasis Leishmaniasis, Cutaneous Leishmaniasis, Mucocutaneous Euglenozoa Infections Protozoan Infections Parasitic Diseases Skin Diseases, Parasitic Skin Diseases, Infectious |
Skin Diseases Meglumine antimoniate Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013