title: International open trial of uniform multidrug therapy regimen for leprosy patients: Findings & implications for national leprosy programmes.
abstract: OBJECTIVE
  Uniform therapy for all leprosy patients will simplify leprosy treatment. In this context, we evaluated six-month multidrug therapy (MDT) currently recommended for multibacillary (MB) patients as uniform MDT (U-MDT) in a single-arm open trial under programme conditions. Primary objective was to determine efficacy to prevent five-year cumulative five per cent relapse. Secondary objectives were to assess acceptability, safety and compliance.
  
  
  METHODS
  Newly detected, treatment-naive leprosy patients were enrolled in India (six sites) and P. R. China (two sites). Primary outcome was clinically confirmed relapse of occurrence of one or more new skin patches consistent with leprosy, without evidence of reactions post-treatment. Event rates per 100 person years as well as five-year cumulative risk of relapse, were calculated.
  
  
  RESULTS
  A total of 2091 paucibacillary (PB) and 1298 MB leprosy patients were recruited from the 3437 patients screened. Among PB, two relapsed (rate=0.023; risk=0.11%), eight had suspected adverse drug reactions (ADRs) (rate=0.79) and rate of new lesions due toreactions was 0.24 (n=23). Rates of neuritis, type 1 and type 2 reactions were 0.39 (n=37), 0.54 (n=51) and 0.03 (n=3), respectively. Among MB, four relapsed (rate=0.07; risk=0.37%) and 16 had suspected ADR (rate=2.64). Rate of new lesions due to reactions among MB was 1.34 (n=76) and rates of neuritis, type 1 and type 2 reactions were 1.37 (n=78), 2.01 (n=114) and 0.49 (n=28), respectively. Compliance to U-MDT was 99 per cent. Skin pigmentation due to clofazimine was of short duration and acceptable.
  
  
  CONCLUSIONS
  We observed low relapse, minimal ADR and other adverse clinical events. Clofazimine-related pigmentation was acceptable. Evidence supports introduction of U-MDT in national leprosy programmes. [CTRI No: 2012/ 05/ 002696].
authors.affiliation: International Trial Co-ordinating Centre, National Institute of Epidemiology (ICMR), Chennai, India.
authors.forename: Ponnaiah
authors.initials: P
authors.lastname: Manickam
authors.affiliation: International Trial Co-ordinating Centre, National Institute of Epidemiology (ICMR), Chennai, India.
authors.forename: Sanjay M
authors.initials: SM
authors.lastname: Mehendale
authors.affiliation: International Trial Co-ordinating Centre, National Institute of Epidemiology (ICMR), Chennai, India.
authors.forename: Bathyala
authors.initials: B
authors.lastname: Nagaraju
authors.affiliation: National JALMA Institute of Leprosy and Other Mycobacterial Diseases, Agra, India.
authors.forename: Kiran
authors.initials: K
authors.lastname: Katoch
authors.affiliation: Former Additional Director of Medical Services (Leprosy), Office of the Director of Medical & Rural Health Services, Chennai, India.
authors.forename: Abdul
authors.initials: A
authors.lastname: Jamesh
authors.affiliation: Former Joint Director of Medical Services (Leprosy), Tiruvannamalai, India.
authors.forename: Ramalingam
authors.initials: R
authors.lastname: Kutaiyan
authors.affiliation: Department for Leprosy Control, National Center for STD and Leprosy Control, Nanjing, P.R. China.
authors.forename: Shen
authors.initials: S
authors.lastname: Jianping
authors.affiliation: Damien Foundation Trust, Chennai, India.
authors.forename: Shivakumar
authors.initials: S
authors.lastname: Mugudalabetta
authors.affiliation: U-MDT Trial Pune Site, Pune, India.
authors.forename: Vitthal
authors.initials: V
authors.lastname: Jadhav
authors.affiliation: International Trial Co-ordinating Centre, National Institute of Epidemiology (ICMR), Chennai, India.
authors.forename: Prabu
authors.initials: P
authors.lastname: Rajkumar
authors.affiliation: International Trial Co-ordinating Centre, National Institute of Epidemiology (ICMR), Chennai, India.
authors.forename: Jayasree
authors.initials: J
authors.lastname: Padma
authors.affiliation: International Trial Co-ordinating Centre, National Institute of Epidemiology (ICMR), Chennai, India.
authors.forename: Kanagasabai
authors.initials: K
authors.lastname: Kaliaperumal
authors.affiliation: WHO Global Leprosy Programme, New Delhi, India.
authors.forename: Vijayakumar
authors.initials: V
authors.lastname: Pannikar
authors.affiliation: Damien Foundation Trust, Chennai, India.
authors.forename: Padabettu
authors.initials: P
authors.lastname: Krishnamurthy
authors.affiliation: International Trial Co-ordinating Centre, National Institute of Epidemiology (ICMR), Chennai, India.
authors.forename: Mohan D
authors.initials: MD
authors.lastname: Gupte
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D002681:China; D003622:Dapsone / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007194:India; D007918:Leprosy / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D012293:Rifampin / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D003622:Dapsone; D012293:Rifampin