Leprosy Patients
Conditions
Interventions
Experimental group: 50 participants after the end of multidrug therapy, will be selected according to the study criteria and will receive statin 40mg / day orally during the period of 12 months. The f
Drug
Sponsors
Instituto Oswaldo Cruz
Instituto Oswaldo Cruz
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: multibacillary patients; treated with the 12-dose MDT regimen with high therapy from June 2019 to April 2020; age> 18 years; treatment for leprosy with discharge at the Souza Araújo Outpatient Clinic; not being on statins for any reason; non-immunosuppressive patients such as HIV-positive, ongoing neoplasms; established renal or hepatic impairment; agree to participate in the project and sign the consent form.
Exclusion criteria
Exclusion criteria: patients with active liver disease and / or unexplained persistent increase in transaminases on the requested tests; patients with renal failure on the exams ordered; pregnancy and lactation; non-course patients need to use statistics other than simvastatin or simvastatin at a dose other than 40mg / day; Known hypersensitivity to any component of the product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reaction charts after discharge: The frequency of reaction charts will be evaluated. The time until the next reaction episode will be evaluated after control of clinical symptoms. The sample size for the outcome of reaction episodes was determined taking into account the 95% confidence level, a power of 80% and the ratio between the two groups of 1: 1, with the proportion of reaction episodes in the control group of 60% and in the exposed group of 30%, we reached the sample size of 100 individuals, with approximately 50 in each group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Bacillary load: Will be determined by bacilloscopic indexes (IB). The average fall in IB after discharge is assessed.For the calculation of the sample size for the outcome difference of mean of the bacilloscopic index in the study period, taking into account the difference of mean of 0.75 between the two groups, we arrived at the sample size of 80 individuals (40 in each group). ;Evaluation of lipid deposits reduction of cutaneous lesion at discharge of multidrug therapy: evaluation of lipids by appropriate immunohistochemical analysis. | — |
Countries
Brazil
Contacts
Public ContactMilton de Moraes
Fundação Oswaldo Cruz
Outcome results
None listed