Status:
COMPLETED
Uniform Multidrug Therapy Regimen for Leprosy Patients
Lead Sponsor:
University of Brasilia
Collaborating Sponsors:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Ministry of Science and Technology, Brazil
Conditions:
Leprosy
Eligibility:
All Genders
6-65 years
Phase:
PHASE4
Brief Summary
The purpose of this randomized trial is to verify if leprosy patients, despite of their classification, can be treated with the same regimen without compromising patient cure and acceptability of the ...
Detailed Description
In the past both the treatment of new leprosy patients and the classification criteria for treatment purposes have gone through major changes. At the moment, newly diagnosed leprosy patients are class...
Eligibility Criteria
Inclusion
- All newly diagnosed leprosy cases with characteristic skin lesions, with or without systemic symptoms or confirmed by histopathological study previously untreated PB and MB leprosy patients.
- Never treated or patient treated more than five years ago
Exclusion
- Safety concerns:
- History of intolerance to one of the medications
- Lack of suitability for the trial:
- Absence of leprosy skin lesions
- Pure neural leprosy (PNL)
- Patient previously (defaulters and relapse) treated for leprosy less than 5 years ago
- Association with other serious diseases such as HIV/AIDS, Tuberculosis, Malaria, American Cutaneous leishmaniasis, Visceral Leishmaniasis, Lymphoma, Leukaemia, Immunosuppression, etc.
- Administrative reasons
- Patients who are not permanent residents of the area or who are unable to come to the clinic every month during their treatment and in the first half year (the intensive follow-up period) after their treatment.
- Patients who do not give informed consent or are not capable to give informed consent due to mental impairment.
- Patients with overt signs of AIDS because it is unlikely that we can follow them up for the whole study period. As we will not be testing patients for HIV positivity, HIV-infected leprosy patients can be included in the study.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2016
Estimated Enrollment :
859 Patients enrolled
Trial Details
Trial ID
NCT00669643
Start Date
February 1 2007
End Date
December 31 2016
Last Update
June 1 2017
Active Locations (2)
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1
Centro de Referência Nacional Alfredo da Matta - FUAM
Manaus, Amazonas, Brazil, 69.065-130
2
Centro de Referência Nacional Dona Libânia - CDERM
Fortaleza, Ceará, Brazil, 60.101-035