A clinical trial for uniform multidrug therapy for leprosy patients in Brazil: rationale and design

Gerson Oliveira Penna,Maria Araci De Andrade Pontes,Maria Lúcia Fernandes Penna,Heitor De Sá Gonçalves,Samira Bührer-Sékula,Rossilene Cruz

doi:10.1590/s0074-02762012000900005

Abstract

Leprosy will continue to be a public health problem for several decades. The World Health Organization (WHO) recommends that, for treatment purposes, leprosy cases be classified as either paucibacillary or multibacillary (MB). A uniform leprosy treatment regimen would simplify treatment and halve the treatment duration for MB patients. The clinical trial for uniform multidrug therapy (U-MDT) for leprosy patients (LPs) in Brazil is a randomised, open-label clinical trial to evaluate if the effectiveness of U-MDT for leprosy equals the regular regimen, to determine the acceptability of the U-MDT regimen and to identify the prognostic factors. This paper details the clinical trial methodology and patient enrolment data. The study enrolled 858 patients at two centres and 78.4% of participants were classified as MB according to the WHO criteria. The main difficulty in evaluating a new leprosy treatment regimen is that no reliable data are available for the current treatment regimen. Relapse, reaction and impaired nerve function rates have never been systematically determined, although reaction and impaired nerve function are the two major causes of nerve damage that lead to impairments and disabilities in LPs. Our study was designed to overcome the need for reliable data about the current treatment and to compare its efficacy with that of a uniform regimen.

Highlights

The current paper presents detailed methodology of the clinical trial and the data obtained from patients far
Leprosy classification is a problem for general health workers who have only received one or two days of training, where leprosy control is fully integrated into health services; the number of areas where this situation occurs will increase in coming years (Barreto et al 2011)
Enrolment status by leprosy type according to World Health Organization criteria based on number of skin lesions and by study centre, uniform multidrug therapy trial, Brazil 2011

Summary

Objectives

To guarantee the enrolment of the patient in the study and initial procedures. To guarantee the patient’s rights as a volunteer and his/her confidence in the research team.RESPONSIBLE: Physician on dutyPRECAUTIONS: ! Always have copies of the consent form (CF) available in the centre. ! Make sure the CF forms include all the correct pages. ! Besides explaining the CF to the patient, give the patient time to read and become familiar with the study in order to avoid problems in the future. ! Do not begin other procedures before certifying the signature of the patient, witness and principal investigator. ! If the patient is illiterate, the signature can be substituted by a right thumb print.MATERIAL: 1. One CRF. 2. To guarantee the enrolment of the patient in the study and initial procedures. To guarantee the patient’s rights as a volunteer and his/her confidence in the research team. Always have copies of the consent form (CF) available in the centre. ! Make sure the CF forms include all the correct pages. ! Besides explaining the CF to the patient, give the patient time to read and become familiar with the study in order to avoid problems in the future. ! Do not begin other procedures before certifying the signature of the patient, witness and principal investigator. ! If the patient is illiterate, the signature can be substituted by a right thumb print.

Methods

Results

Discussion

Conclusion