Leprosy, chemoprevention, clinical trial, rifampicin.
Conditions
Interventions
Contacts of leprosy patients with multibacillary clinical form will be included in the study. The contacts will receive a single supervised dose of rifampicin or placebo according to the group for whi
Drug
Sponsors
Instituto Oswaldo Cruz - Laboratório de Hanseníase
Escola Nacional de Saúde Pública Sérgio Arouca
Eligibility
Age
6 Months to 70 Years
Inclusion criteria
Inclusion criteria: Contacts of patients with multibacillary leprosy who agreed to undergo chemoprophylaxis; age from 6 months to 70 years; willingness to undergo clinical and anti-PGL-1 evaluation; availability for follow-up; return for vaccination in two months and for clinic evaluation in 12 months.
Exclusion criteria
Exclusion criteria: Clinical or laboratory confirmation of leprosy at baseline; BCG vaccination in the preceding 12 months, except for infants between 6 and 12 months of age; contacts with immunosuppression or history of tuberculosis in all its forms; pregnancy at any stage, or refusal to undergo urine pregnancy test and refusal to sign the informed consent form (ICF).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Leprosy cases during follow-up. The assessment of the cases will be based on the identification of cutaneous lesions with changes in sensitivity and thickened nerves. Clinical diagnosis will be given by professionals with experience in leprosy, including a dermatologist and a nurse responsible for the dermatological, clinical and previous history evaluation, and a physiotherapist responsible for neurological assessment. Contacts with suspect clinical leprosy will be submitted to bacteriological, histopathological and immunological tests, and classified according to the scale of Ridley and Jopling (1966) [17] as: borderline-borderline, borderline-lepromatous leprosy, lepromatoso-lepromatoso, tuberculoid, borderline-tuberculoid tuberculoid, or undetermined-. Confirmed cases will also be grouped according to their degree of disability and the bacilloscopic index (IB) as multibacillary (MB), if IB-positive, or paucibacillary (PB) if IB-negative. Binary variable analysis: sick, healthy. ;Serological status to anti-PGL-I: obtained through blood collections performed before chemoprophylaxis in the 1st evaluation, before immunoprophylaxis in the 2nd evaluation in 2 months, and in the 3rd evaluation in 12 months. The quantitative variables analyzed will be those related to the ELISA results on anti-PGL-I: The optical density (OD) will be read at 450 nm. Anti-PGL-1 positive samples with OD> 0.25 ;Serological status to anti-LID-I:obtained through blood collections performed before chemoprophylaxis in the 1st evaluation, before immunoprophylaxis in the 2nd evaluation in 2 months, and in the 3rd evaluation in 12 months. The quantitative variables analyzed will be those related to the ELISA results on anti-LID-1: The optical density (OD) will be read at 450 nm. Anti-LID-1: positive samples with OD> 0.30.;PCR result: Obtained through the collection of dermal scraping of the auricular lobe in the 1st evaluation and in the 2nd evaluation (for positive or inconclusive results in t | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events potentially associated with rifampicin: Will be identified after the 1st evaluation through clinical evaluation, will be registered in a proper form. ;Intercurrent clinical conditions associated with the intervention: Will be identified after the 1st evaluation through clinical evaluation, will be registered in a proper form. | — |
Countries
Brazil
Contacts
Public ContactDaiane Santos dos Santos
Escola Nacional de Saúde Pública Sérgio Arouca
Outcome results
None listed