Uniform Multidrug Therapy Regimen for Leprosy Patients
Condition: Leprosy
MeSH terms: Leprosy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this randomized trial is to verify if leprosy patients, despite of their
      classification, can be treated with the same regimen without compromising patient cure and
      acceptability of the treatment. At present, patients classified as multibacillary leprosy are
      treated for 12 months with three drugs, and patients classified as paucibacillary leprosy are
      treated for 6 months with two drugs. The study is going to test a unified regimen for
      paucibacillary and multibacillary patients by treating leprosy patients with three drugs for
      6 doses.
    

Detailed description: 
      In the past both the treatment of new leprosy patients and the classification criteria for
      treatment purposes have gone through major changes. At the moment, newly diagnosed leprosy
      patients are classified into PB and MB based on the number of lesions only. More than 5
      lesions leads to a classification as MB patient and treatment for 12 months with MDT composed
      of three drugs, i.e. rifampicin, dapsone and clofazimine. One to 5 lesions leads to a
      classification as PB patient and treatment for 6 months with MDT composed of two drugs, i.e.
      rifampicin and dapsone.

      Despite all the favorable data from the point of view of practical application, this
      therapeutic regimen still presents some constraints, including the lengthy course of
      treatment. Especially in those situations where leprosy control is integrated into the
      general health services classification is a problem for the general health worker that has
      only received one or two days of training in leprosy.

      A uniform regimen for leprosy would simplify treatment in the field. Results from control
      programs and research projects have demonstrated that relapse rates after MDT are extremely
      low, approximately 0.2% annually among MB cases on the 24-dose regimen. The low relapse rates
      indicate that there was room to shorten the course of MDT to less than 24 monthly-supervised
      doses of rifampicin plus self-administered doses of dapsone and clofazimine. Although some
      papers have suggested that relapse rates after MDT may be significantly higher in MB patients
      with an initial bacterial index equals or bigger than 3, the present diagnostic universe of
      leprosy includes few such patients, and the total number of relapses caused by them would
      account for a minimal percentage of cases in a control program. Since 1998, a 12-month
      treatment course for MB leprosy is advised by WHO. The main problem when evaluating any new
      treatment regimen for leprosy, is that there are no good and reliable data available for the
      current treatment regimen: relapse rates have never been systematically determined and the
      same holds true for reaction and nerve function impairment rates, the major cause of the
      nerve damage that leads to handicaps and deformities in leprosy patients.

      Currently, WHO is exploring possibilities to introduce a short uniform treatment regimen for
      all types of leprosy patients called Uniform Multidrug Therapy (U-MDT), as a replacement for
      the present regular multidrug therapy (R-MDT). This U-MDT would consist of treatment of all
      patients for 6 months with a regimen consisting of three drugs: rifampicin, dapsone and
      clofazimine. The efficacy of this U-MDT is currently being studied in an open non-controlled
      treatment trial. Classification of patients is only done on clinical criteria: no skin smears
      or other lab tests are included. The diagnosis of relapse will rely on clinical diagnosis
      only. It will therefore not be possible to identify high-risk groups for relapse, such as
      highly skin smear positive patients.

      The objective of our study is to evaluate both the R-MDT and the U-MDT regimens in a
      randomised trial in order to:

        1. determine the efficacy of the current R-MDT regimen with regard to relapse rates and
           acceptability to the patient.

        2. determine the efficacy of the U-MDT regimen with regard to relapse rate and
           acceptability to the patient.
    

Intervention name(s): PB 6 doses - Rifampicin and Dapsone; PB 6 doses - Rifampicin, Clofazimine and Dapsone; MB 12 doses - Rifampicin, Clofazimine and Dapsone; MB 6 doses - Rifampicin, Clofazimine and Dapsone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Adult: 6 doses;
1 monthly supervised dose: 600 mg Rifampicin + 100 mg Dapsone; 27 days: p/day - 100 mg Dapsone;
Children: 6 doses;
1 monthly supervised dose: 450 mg Rifampicin + 50 mg Dapsone; 27 days: p/day - 50 mg Dapsone; Adult: 6 doses;
1 monthly supervised dose: 600 mg Rifampicin + 300 mg Clofazimine + 100 mg Dapsone; 27 days: p/day - 100 mg Dapsone + 50 mg Clofazimine;
Children: 6 doses;
1 monthly supervised dose: Rifampicin 450 mg + 150 mg Clofazimine + 50 mg Dapsone; 27 days: p/day - 50 mg Dapsone + 25 mg Clofazimine; Adult: 12 doses;
1 monthly supervised dose: 600 mg Rifampicin + 300 mg Clofazimine + 100 mg Dapsone; 27 days: p/day - 100 mg Dapsone + 50 mg Clofazimine;
Children: 12 doses;
1 monthly supervised dose: Rifampicin 450 mg + 150 mg Clofazimine + 50 mg Dapsone; 27 days: p/day - 50 mg Dapsone + 25 mg Clofazimine; Adult: 6 doses
1 monthly supervised dose: 600 mg Rifampicin + 300 mg Clofazimine + 100 mg Dapsone; 27 days: p/day - 100 mg Dapsone + 50 mg Clofazimine
Children: 6 doses
1 monthly supervised dose: Rifampicin 450 mg + 150 mg Clofazimine + 50 mg Dapsone; 27 days: p/day - 50 mg Dapsone + 25 mg Clofazimine
Other intervention name(s): PB 6 doses of 2 drugs; PB 6 doses of 3 drugs; MB 12 doses of 3 drugs; MB 6 doses of 3 drugs
Intervention MeSH terms: Rifampin; Dapsone; Clofazimine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Leprosy; Communicable Diseases; Skin Diseases; Multidrug Therapy; MDT; Uniform Multidrug Therapy; U-MDT