Dept. of Health Research Govt. of India
World Health Organization
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Name of the Project Uniform Multi-Drug Therapy regimen for all leprosy patients
Principal Investigator Dr Sanjay Mehendale (International Trial Co-ordinator)
Co-Principal Investigator(s) -
Other Investigator(s)

 

 

Indian sites

 

 

China

Pune

Villupuram

Tiruvannamalai

Gaya & Rohtas

Agra

Guizhou & Yunnan

PI

Vitthal Jadhav

K Ramalingam

K Ramalingam

M shivaKumar

Kiran Katoch

Shen Jianping

Co-PI(s)

-

-

-

-

-

Collaboration / Participating Centers

Indian sites

  • Pune
  • Villupuram
  • Tiruvannamalai
  • Gaya & Rohtas
  • Agra

China

  • Guizhou & Yunnan
Funding Agency / Sponsor WHO/TDR
Budget Awaited
Study Period 2003-2017
Objectives The primary objective is to assess treatment response to 6 months’ Uniform MDT (UMDT) for all types of leprosy patients in terms of relapse rate not exceeding a maximum acceptable cumulative level of 8% at the end of 8 years

Secondary objectives are to assess acceptability, safety and compliance
Description Prevalence of leprosy has decreased globally, clearing the way for integrating leprosy services into the general health services. In this context, NIE is coordinating a WHO-TDR supported multi-centric trial to assess efficacy of a six-month uniform multi-drug therapy (U-MDT) for all types of leprosy patients.

The study is an open design requiring 1750 newly detected, previously untreated patients each in multi-bacillary (MB) and pauci-bacillary (PB) groups.  We recruited 1302 in multi-bacillary (MB) and 2094 pauci-bacillary (PB) groups from India (six centres) and China (two centres). Standardized clinical criteria were used to assess skin lesions in the field. The patients are being followed up for the clinical status annually.
Quarterly Reports (5-10 lines) A review meeting of the study involving the Principal Investigators, co-PIs, study personnel and invited experts from WHO was held during 7-8 March 2011. During the meeting, the sample size was re-calculated on the basis of available data indicating that the attrition rate was actually 2% per year than assumed rate of 6% per year. Based on these observations (1750 patients would be sufficient for each type of leprosy), the expert group felt that there is no need for further recruitment of new MB patients and that they should concentrate on following up of already recruited patients. 
 
The study enrolled 3396 patients from November 2003 (India: 3230; China: 166). Of the 3396 patients, 38% were MB and 4% had grade 2 disability.  During follow-up, 78 patients developed new lesions and 121 type I reactions were reported. Five patients had clinically confirmed relapse. All these patients were assessed as ‘lesion inactive’ at the completion of treatment. Subsequently they developed new lesions, and were given another course of U-MDT, and are being followed up. Clofazimine related skin pigmentation was short-lived and was acceptable to patients. Totally 512 patients were lost to follow-up as on December 2011. Of the 3396 patients, 2745 completed treatment. Of these who completed treatment skin lesions were inactive in 753 (44.5%) PB patients and in 117 (11.1%) MB patients. At the end of first five years of follow up, lesions were inactive in 73% (I year), 88% (II year), 95% (III year), 97.2% (IV year) and 97.8% (V year) in PB patients. In the MB group, lesions were inactive in 45% (I year), 64% (II year), 79% (III year), 85% (IV year) and 87% (V year).
Significant achievements U-MDT appears to be promising with respect to clinical status of skin lesions of all types of leprosy. Proportion of inactive lesions in MB patients documented the effectiveness of shortened duration of UMDT regimen and it is effective, acceptable and operationally convenient under programme conditions. Clofazimine related skin pigmentation was usually of short duration and acceptable to PB patients.
Publications Kroger A, Pannikar V, Htoon MT, Jamesh A, Katoch K, Krishnamurthy P, Ramalingam K, Jianping S, Jadhav V, Gupte MD, 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. Trop Med Int Health. 2008; 13(5): 594-602