Uniform Multidrug Therapy Regimen for Leprosy Patients

• Status: Completed
• Trial end date: 2016-12-31
• Target enrollment: 0
• Participant gender: All

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 treatment. At present, patients classified as multibacillary leprosy are treated for 12 months with three drugs, and patients classified as paucibacillary leprosy are treated for 6 months with two drugs. The study is going to test a unified regimen for paucibacillary and multibacillary patients by treating leprosy patients with three drugs for 6 doses.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Brasilia
• Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico; Fundação Alfredo da Matta, Manaus, Brazil; Instituto de Dermatologia Dona Libania, Fortaleza, Brazil; Ministry of Health, Brazil; Ministry of Science and Technology, Brazil
• Treatments: Clofazimine; Dapsone; Rifampin

Criteria

Inclusion Criteria:

• 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 Criteria:

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.