We describe a further simplification of a dipstick assay for the detection of antibodies to phenolic glycolipid I of Mycobacterium leprae by using whole blood and evaluated the assay performance in the leprosy endemic area of Amazonas in Brazil. The agreement with the 'gold' standard ELISA was 94.9% (kappa value = 0.87). This simple assay may be useful to identify those at risk of developing leprosy, for example among contacts of leprosy patients at lower levels in the health services.
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.Key words: leprosy -protocol -clinical trial -uniform multidrug therapy U-MDT leprosy clinical trial -Brazil • Gerson Oliveira Penna et al. 23has been generally recommended by the WHO since 1998 (WHO 1997a. Although some studies suggest that post-MDT relapse rates may be significantly higher in the MB patients who have an initial bacterial index (BI) ≥ 4 (Jamet & Ji 1995), the present leprosy disease group includes few patients with those characteristics. Furthermore, the total number of relapses among these patients would account for a minimal percentage of cases in a control programme (WHO 1997b).The objective of this clinical trial is to evaluate whether uniform (U)-MDT for leprosy is clinically and statistically equivalent in efficacy to the regular regimen (R-MDT), to determine patient tolerability of the U-MDT regimen among PB patients and to identify the prognostic factors that might influence the U-MDT outcomes.The current paper presents detailed methodology of the clinical trial and the data obtained from patients thus far. SUBJECTS, MATERIALS AND METHODS Study design -An open-label, randomised clinical trial design was used to compare two treatment regimens (R-MDT vs. U-MDT) with monthly patient follow-ups during the treatment period and for the first six months following treatment cessation for the MB patients in the U-MDT study group. This procedure was followed by yearly post-treatment visits for six years. The study population included newly diagnosed, previously untreated PB and MB leprosy patients (LPs) and returning defaulters and relapse cases, provided that the last treatment dose was more than five years prior to enrolment in the study. All of ...
BackgroundThe predictive value of the serology to detection of IgM against the Mycobacterium leprae-derived phenolic glycolipid-I/PGL-I to identify leprosy patients who are at higher risk of developing reactions remains controversial. Whether baseline results of the ML Flow test can predict leprosy reactions was investigated among a cohort of patients enrolled in The Clinical Trial for Uniform Multidrug Therapy for Leprosy Patients in Brazil (U-MDT/CT-BR).MethodsThis was a descriptive study focusing on the main clinical manifestations of leprosy patients enrolled in the U-MDT/CT-BR from March 2007 to February 2012 at two Brazilian leprosy reference centers. For research purposes, 753 leprosy patients were categorized according to a modified Ridley-Jopling (R&J) classification and according to the development of leprosy reactions (reversal reaction/RR and erythema nodosum leprosum/ENL), and whether they had a positive or negative bacillary index/BI.ResultsMore than half of the patients (55.5 %) reported leprosy reaction: 18.3 % (138/753) had a RR and 5.4 % (41/753) had ENL. Leprosy reactions were more frequent in the first year following diagnosis, as seen in 27 % (205/753) of patients, while 19 % (142/753) developed reactions during subsequent follow-up. Similar frequencies of leprosy reactions and other clinical manifestations were observed in paucibacillary (PB) and multibacillary (MB) leprosy patients treated with U-MDT and regular MDT (R-MDT) (P = 0.43 and P = 0.61, respectively). Compared with PB patients, leprosy reactions were significantly more frequent in MB patients with a high BI, and more patients developed RR than ENL. However, RR and neuritis were also reported in patients with a negative BI. At baseline, the highest rate of ML Flow positivity was observed in patients with a positive BI, especially those who developed ENL, followed by patients who had neuritis and RR. Among reaction-free patients, 81.9 % were ML Flow positive, however, the differences were not statistically significant compared to reactional patients (P = 0.45).ConclusionsMB and PB patients treated with R-MDT and U-MDT showed similar frequencies of RR and other clinical manifestations. Positive ML Flow tests were associated with MB leprosy and BI positivity. However, ML Flow test results at baseline showed limited sensitivity and specificity for predicting the development of leprosy reactions.Electronic supplementary materialThe online version of this article (doi:10.1186/s40249-016-0203-0) contains supplementary material, which is available to authorized users.
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