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Low Antimonial Dosage in American Mucosal Leishmaniasis

This study is currently recruiting participants.
Verified May 2017 by ASchubach, Oswaldo Cruz Foundation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01301937
First Posted: February 23, 2011
Last Update Posted: May 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
ASchubach, Oswaldo Cruz Foundation
  Purpose
"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.

Condition Intervention Phase
Mucosal Leishmaniasis Mucocutaneous Leishmaniasis Drug: Meglumine antimoniate Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III Clinical Trial for Mucosal or Mucocutaneous Leishmaniasis. Comparison Between the Standard and Alternative Antimonial Schemes

Resource links provided by NLM:


Further study details as provided by ASchubach, Oswaldo Cruz Foundation:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 76
Study Start Date: October 2008
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: High continuous dose
Meglumine antimoniate 20 mg/kg/day for 30 continuous days
Drug: Meglumine antimoniate

Meglumine antimoniate (Aventis, São Paulo, Brazil) is stored and ministered under actual conditions employed by the health services in Brazil. Each patient will be included in one of two treatment groups with meglumine antimoniate IM:

  1. High continuous dose: 20 mg/kg/day for 30 continuous days.
  2. Low continuous dose 5 mg/kg/day for up to 120 continuous days.

There will be no cross-over between the groups for the purpose of this study. The data from those patients who require permanent discontinuation of a scheme will be assessed in the group that were randomized, ie, by intention to treat

Arms: High continuous dose, Low continuous dose

Other Name: Glucantime
Active Comparator: Low continuous dose
Meglumine antimoniate 5 mg/kg/day for up to 120 continuous days according to clinical cure
Drug: Meglumine antimoniate

Meglumine antimoniate (Aventis, São Paulo, Brazil) is stored and ministered under actual conditions employed by the health services in Brazil. Each patient will be included in one of two treatment groups with meglumine antimoniate IM:

  1. High continuous dose: 20 mg/kg/day for 30 continuous days.
  2. Low continuous dose 5 mg/kg/day for up to 120 continuous days.

There will be no cross-over between the groups for the purpose of this study. The data from those patients who require permanent discontinuation of a scheme will be assessed in the group that were randomized, ie, by intention to treat

Arms: High continuous dose, Low continuous dose

Other Name: Glucantime

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01301937


Contacts
Contact: Armando O. Schubach, MD, PhD (55)(21)38659541 vigileish@ipec.fiocruz.br
Contact: Claudia M. Valete-Rosalino, MD, PhD (55)(21)38659541 vigileish@ipec.fiocruz.br

Locations
Brazil
Oswaldo Cruz Foundation - IPEC/FIOCRUZ Recruiting
Rio de Janeiro, Brazil, 21040-360
Sub-Investigator: Armando O. Schubach, MD, PhD         
Sponsors and Collaborators
Oswaldo Cruz Foundation
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Study Director: Armando O. Schubach, MD, PhD IPEC/FIOCRUZ
  More Information

Publications:

Responsible Party: ASchubach, Senior Researcher, Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier: NCT01301937     History of Changes
Other Study ID Numbers: low dosage ML
First Submitted: February 20, 2011
First Posted: February 23, 2011
Last Update Posted: May 23, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by ASchubach, Oswaldo Cruz Foundation:
Mucosal Leishmaniasis
Leishmania braziliensis
Meglumine Antimoniate
Treatment Effectiveness
Controlled Clinical Trials, Randomized

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Mucocutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Leishmaniasis, Cutaneous
Meglumine antimoniate
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents