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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01301937 |
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Date of registration:
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20/02/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Low Antimonial Dosage in American Mucosal Leishmaniasis
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Scientific title:
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Phase III Clinical Trial for Mucosal or Mucocutaneous Leishmaniasis. Comparison Between the Standard and Alternative Antimonial Schemes |
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Date of first enrolment:
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October 2008 |
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Target sample size:
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76 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT01301937 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Armando O. Schubach, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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IPEC/FIOCRUZ |
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Name:
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Armando O. Schubach, MD, PhD |
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Address:
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Telephone:
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(55)(21)38659541 |
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Email:
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vigileish@ipec.fiocruz.br |
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Affiliation:
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Key inclusion & exclusion criteria
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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)
Age minimum:
13 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Mucosal Leishmaniasis
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Mucocutaneous Leishmaniasis
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Intervention(s)
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Drug: Meglumine antimoniate
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Primary Outcome(s)
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Efficacy of meglumine antimoniate in the treatment of mucosal leishmaniasis
[Time Frame: 6 years]
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Secondary Outcome(s)
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Safety of meglumine antimoniate in the treatment of mucosal leishmaniasis
[Time Frame: 6 years]
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Secondary ID(s)
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low dosage ML
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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