Health Condition 1: A304- Borderline lepromatous leprosy Health Condition 2: A302- Borderline tuberculoid leprosy Health Condition 3: A305- Lepromatous leprosy
Conditions
Interventions
Intervention1: Once monthly RMC regime: Rifampicin 600 mg
Moxifloxacin 500 mg
Clarithromycin 1000 mg
Once monthly for 12 months
Control Intervention1: WHO MB MDT regime: Rifampicin 600 once monthly
Sponsors
The leprosy mission Trust India
Eligibility
Inclusion criteria
Inclusion criteria: Multibacillary (MB) leprosy, defined as 5 or more skin lesions or extensive infiltration and /or diffuse skin involvement, classified as borderline tuberculoid, borderline lepromatous or polar lepromatous, as determined using Ridley and Jopling classification system.
Exclusion criteria
Exclusion criteria: 1.History of intolerance to one of the medications. 2.Patients who are not able to come to the clinic every month during their treatment and during follow up. 3.Patients who do not give informed consent or are not capable to give informed consent due to mental impairment. 4.Immunocompromised patients diagnosed with HIV/AIDS and Tuberculosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy outcomes: 1. Molecular -Reduction of copy numbers by MVA -Complete killing of M. leprae as demonstrated in MFP. 2. Clinical -Complete clinical cure, defined as full regression of the lesions. -Clinical improvement of the lesions defined by a clinical criterion 3. Pathological -Bacillary index (Bl) improvement -Improved biopsy findings Timepoint: 1.Reduction of copy numbers by MVA - baseline , 6 months and 12 months Complete killing of M. leprae as demonstrated in MFP - 24 months Complete clinical cure, defined as full regression of the lesions - 6 months and 12 months Clinical improvement of the lesions defined by a clinical criterion - 12 months -Bacillary index (Bl) improvement - 3 , 6 and 12 months -Improved biopsy findings - 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Immunological outcomes - Neuritis -if participants reported pain during the interview or when Nerve function impairment is detected on routine test. - Type I reaction - Incidence and improvement in severity score between the 2 regimes. - Type 2 reaction - Incidence and improvement in severity score between the 2 regimes. 2. Safety outcomes - Severe side effects (defined as a side effect that forced the patient to stop the treatment), - mild to moderate side effects. 3. Qualitative outcomes - Impact of leprosy treatment on life - Perspective towards leprosy treatment - Cost of treatment Timepoint: 1. Immunological outcomes - 12 mons 2.Safety outcomes - 12 mons 3. Qualitative outcomes Impact of leprosy treatment on life - 12 mons - Perspective towards leprosy treatment - Cost of treatment | — |
Countries
India
Contacts
Public ContactJoydeepa Darlong
The leprosy mission trust India
Outcome results
None listed