Uniform Multidrug Therapy Regimen for Leprosy Patients (U-MDT)
Leprosy
About this trial
This is an interventional treatment trial for Leprosy focused on measuring Leprosy, Communicable Diseases, Skin Diseases, Multidrug Therapy, MDT, Uniform Multidrug Therapy, U-MDT
Eligibility 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.
Sites / Locations
- Centro de Referência Nacional Alfredo da Matta - FUAM
- Centro de Referência Nacional Dona Libânia - CDERM
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Experimental
Experimental
Experimental
R-MDT PB
U-MDT PB
R-MDT MB
U-MDT MB
R-MDT PB group: standard/regular treatment recommended by WHO - All patients presenting fewer than 6 skin lesions will receive the standard treatment regimen for paucibacillary patients as the intervention; Intervention - PB 6 doses of rifampicin and dapsone
U-MDT PB group: a unified treatment for all patients - All patients presenting fewer than 6 lesions (WHO PB) will receive 6 doses of rifampicin, clofazimine and dapsone as the intervention; Intervention - PB 6 doses of rifampicin, clofazimine and dapsone
R-MDT MB group: standard/regular treatment recommended by WHO - All patients presenting 6 skin or more lesions will receive the standard treatment regimen for multibacillary patients as the intervention; Intervention - MB 12 doses of rifampicin, clofazimine and dapsone
U-MDT MB group: a unified treatment for all patients - All patients presenting 6 lesions or more (WHO MB) will receive 6 doses of rifampicin, clofazimine and dapsone as the intervention; Intervention - MB 6 doses of rifampicin, clofazimine and dapsone