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

• Published in: Tropical medicine & international health 2008-05, Vol.13 (5), p.594-602
• Main Authors: Kroger, Axel, Pannikar, V, Htoon, M.T, Jamesh, A, Katoch, K, Krishnamurthy, P, Ramalingam, K, Jianping, Shen, Jadhav, Vitthal, Gupte, M.D, Manickam, P
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Bacterial diseases; Bacterial Skin Diseases; Biological and medical sciences; Child; China; clinical trial; Clinical trials; Clofazimine; Clofazimine - therapeutic use; Combination Drug Therapy; Comparative studies; Dapsone; Dapsone - therapeutic use; Drug therapy; Drug Therapy, Combination; ensayo clínico; Ensayo quimioterapia lepra; essai chimiothérapique de la lèpre; essai clinique; Female; General aspects; Human bacterial diseases; Humans; India; Infectious diseases; Leprostatic Agents; Leprostatic Agents - adverse effects; Leprostatic Agents - therapeutic use; Leprosy; Leprosy - drug therapy; leprosy chemotherapy trial; Male; Medical sciences; Middle Aged; múltiples medicamentos; Pharmacology; Rifampin; Rifampin - therapeutic use; Skin; Skin Diseases, Bacterial - drug therapy; terapia uniforme; thérapie uniforme multi‐médicamenteuse; Treatment Outcome; Tropical bacterial diseases; Tuberculosis and atypical mycobacterial infections; uniform multi-drug therapy
• ISSN: 1360-2276; 1365-3156
• DOI: 10.1111/j.1365-3156.2008.02045.x

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. 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. 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 follow-up 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). U-MDT appears to be promising with respect to clinical status of skin lesions.