International Open Trial of Uniform Multi-Drug Therapy Regimen for 6 Months for All Types of Leprosy Patients : Rationale, Design and Preliminary Results

International Open Trial of Uniform Multi-Drug Therapy Regimen for 6 Months for All Types of Leprosy Patients : Rationale, Design and Preliminary Results

OBJECTIVE: 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...

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Main Authors: Kroger, A., Pannikar, V., Htoon, M. T., Jamesh, A., Katoch, K., Krishnamurthy, P., Ramalingam, K., Jianping, S., Jadhav, V., Gupte, M. D., Manickam, P.
Format: Journal Article
Language:EN
Published: 2012
Subjects:
Adolescent
Adult
Aged
Child
China
Clofazimine
Dapsone
Combination Drug Therapy
Female
Humans
India
Leprostatic Agents
Leprosy
Male
Middle Aged
Rifampin
Bacterial Skin Diseases
Treatment Outcome
Online Access:http://hdl.handle.net/10986/5101
id okr-10986-5101
recordtype oai_dc
spelling okr-10986-51012021-04-23T14:02:21Z International Open Trial of Uniform Multi-Drug Therapy Regimen for 6 Months for All Types of Leprosy Patients : Rationale, Design and Preliminary Results Kroger, A. Pannikar, V. Htoon, M. T. Jamesh, A. Katoch, K. Krishnamurthy, P. Ramalingam, K. Jianping, S. Jadhav, V. Gupte, M. D. Manickam, P. Adolescent Adult Aged Child China Clofazimine Dapsone Combination Drug Therapy Female Humans India Leprostatic Agents Leprosy Male Middle Aged Rifampin Bacterial Skin Diseases Treatment Outcome OBJECTIVE: 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 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). CONCLUSION: U-MDT appears to be promising with respect to clinical status of skin lesions. 2012-03-30T07:31:17Z 2012-03-30T07:31:17Z 2008-05 Journal Article Trop Med Int Health 1365-3156 (Electronic) 1360-2276 (Linking) http://hdl.handle.net/10986/5101 EN http://creativecommons.org/licenses/by-nc-nd/3.0/igo World Bank Journal Article
repository_type Digital Repository
institution_category Foreign Institution
institution Digital Repositories
building World Bank Open Knowledge Repository
collection World Bank
language EN
topic Adolescent
Adult
Aged
Child
China
Clofazimine
Dapsone
Combination Drug Therapy
Female
Humans
India
Leprostatic Agents
Leprosy
Male
Middle Aged
Rifampin
Bacterial Skin Diseases
Treatment Outcome
spellingShingle Adolescent
Adult
Aged
Child
China
Clofazimine
Dapsone
Combination Drug Therapy
Female
Humans
India
Leprostatic Agents
Leprosy
Male
Middle Aged
Rifampin
Bacterial Skin Diseases
Treatment Outcome
Kroger, A.
Pannikar, V.
Htoon, M. T.
Jamesh, A.
Katoch, K.
Krishnamurthy, P.
Ramalingam, K.
Jianping, S.
Jadhav, V.
Gupte, M. D.
Manickam, P.
International Open Trial of Uniform Multi-Drug Therapy Regimen for 6 Months for All Types of Leprosy Patients : Rationale, Design and Preliminary Results
relation http://creativecommons.org/licenses/by-nc-nd/3.0/igo
description OBJECTIVE: 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 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). CONCLUSION: U-MDT appears to be promising with respect to clinical status of skin lesions.
format Journal Article
author Kroger, A.
Pannikar, V.
Htoon, M. T.
Jamesh, A.
Katoch, K.
Krishnamurthy, P.
Ramalingam, K.
Jianping, S.
Jadhav, V.
Gupte, M. D.
Manickam, P.
author_facet Kroger, A.
Pannikar, V.
Htoon, M. T.
Jamesh, A.
Katoch, K.
Krishnamurthy, P.
Ramalingam, K.
Jianping, S.
Jadhav, V.
Gupte, M. D.
Manickam, P.
author_sort Kroger, A.
title International Open Trial of Uniform Multi-Drug Therapy Regimen for 6 Months for All Types of Leprosy Patients : Rationale, Design and Preliminary Results
title_short International Open Trial of Uniform Multi-Drug Therapy Regimen for 6 Months for All Types of Leprosy Patients : Rationale, Design and Preliminary Results
title_full International Open Trial of Uniform Multi-Drug Therapy Regimen for 6 Months for All Types of Leprosy Patients : Rationale, Design and Preliminary Results
title_fullStr International Open Trial of Uniform Multi-Drug Therapy Regimen for 6 Months for All Types of Leprosy Patients : Rationale, Design and Preliminary Results
title_full_unstemmed International Open Trial of Uniform Multi-Drug Therapy Regimen for 6 Months for All Types of Leprosy Patients : Rationale, Design and Preliminary Results
title_sort international open trial of uniform multi-drug therapy regimen for 6 months for all types of leprosy patients : rationale, design and preliminary results
publishDate 2012
url http://hdl.handle.net/10986/5101
_version_ 1764393948789342208

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