International open trial of uniform multi‐drug therapy regimen for 6 months for all types of leprosy patients: rationale, design and preliminary results

Abstract

Summaryobjective To describe the rationale, design and preliminary results of an open trial of 6 months uniform multi-drug therapy (U-MDT) for all types of leprosy patients assuming a cumulative relapse rate not exceeding 5% over 5 years of follow-up.methods We intended to recruit 2500 patients each in multi-bacillary (MB) and pauci-bacillary (PB) groups from India (five centres) and China (two centres). Standardized clinical criteria were used to assess skin lesions in the field.results A total of 2912 patients enrolled from November 2003 to May 2007 (India, 2746 China, 166). MB patients constituted 39% and 3% had grade 2 disability. During follow-up, 27 patients (0.9%) developed new lesions. Of these, 78% were on account of reactions. Six patients had clinically confirmed relapse. Clofazimine-related skin pigmentation was short-lived and was acceptable to patients. We analysed data for clinical status of skin lesions. About 2.9% of patients were lost to follow-up; 85.9% completed treatment, of whom 19% had inactive skin lesions. PB patients responded better than MB patients (27% vs. 6%; P < 0.001). At the end of the first (n = 2013) and second year (n = 807) of followup post-U-MDT, in 49% and 46% patients, lesions were inactive, respectively (59% and 57% in PB, 37% and 28% in MB; P < 0.001).conclusion U-MDT appears to be promising with respect to clinical status of skin lesions.

Rapid Quantitative Serological Test for Detection of Infection with Mycobacterium leprae, the Causative Agent of Leprosy

“…We hypothesize that, in parallel with clinical examinations, thorough quantification of serological antibody responses by Smart Reader will allow us to capture nonresponse to treatment. Given that truncated treatment regimens are being proposed (33)(34)(35)(36), projecting how a patient will respond to treatment without the need for invasive skin slits or biopsies would be an important and practical tool in trial design. Expanding evaluations into the treatment phase could ultimately provide objective guidelines for clinicians to identify high-risk groups requiring additional monitoring, permitting streamlining and prioritization within currently stretched control programs.…”

Neurologic manifestations of the neglected tropical diseases

“…Nerve abscess and T2 hyperintensities in the spinal cord on MRI have been rarely reported [136,139]. Leprosy is one of the few NTDs for which multiple clinical trials have been conducted, demonstrating success of RCD (rifampicin, clofazimine, dapsone) for multibacillary leprosy, ROM (rifampicin, ofloxacin, minocycline) for paucibacillary leprosy, and uniform multidrug therapy (U-MDT, rifampicin, clofazimine, dapsone for 6 months) for all types of leprosy [140][141][142]. Although prednisolone is commonly used for the treatment of neuropathy, the long-term benefit is uncertain [143].…”

Considerations on clinical trials of leprosy treatment: need of novel drug combinations

“…The uniform-MDT regimen consists of 6 months of MB WHO-MDT for all new cases regardless of clinical form or bacterial status. A multicenter trial is in progress in India and China [67]. Other controlled trials have likewise been initiated in India [68] and Brazil [69] (Table 2).…”