Drug trial in leprosy containing rifampicin , moxifloxacin and Clarithromycin versus routine MBMDT.
Phase 3
- Conditions
- Health Condition 1: A304- Borderline lepromatous leprosyHealth Condition 2: A302- Borderline tuberculoid leprosyHealth Condition 3: A305- Lepromatous leprosy
- Registration Number
- CTRI/2024/03/064435
- Lead Sponsor
- The leprosy mission Trust India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary efficacy outcomes: <br/ ><br>1. Molecular <br/ ><br>-Reduction of copy numbers by MVA <br/ ><br>-Complete killing of M. leprae as demonstrated in MFP. <br/ ><br>2. Clinical <br/ ><br>-Complete clinical cure, defined as full regression of the lesions. <br/ ><br>-Clinical improvement of the lesions defined by a clinical criterion <br/ ><br>3. Pathological <br/ ><br>-Bacillary index (Bl) improvement <br/ ><br>-Improved biopsy findings <br/ ><br>Timepoint: 1.Reduction of copy numbers by MVA - baseline , 6 months and 12 months <br/ ><br>Complete killing of M. leprae as demonstrated in MFP - 24 months <br/ ><br>Complete clinical cure, defined as full regression of the lesions - 6 months and 12 months <br/ ><br>Clinical improvement of the lesions defined by a clinical criterion - 12 months <br/ ><br>-Bacillary index (Bl) improvement - 3 , 6 and 12 months <br/ ><br>-Improved biopsy findings - 12 months <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1. Immunological outcomes <br/ ><br>-Neuritis -if participants reported pain during the interview or when Nerve function impairment is detected on routine test. <br/ ><br>-Type I reaction - Incidence and improvement in severity score between the 2 regimes. <br/ ><br>-Type 2 reaction - Incidence and improvement in severity score between the 2 regimes. <br/ ><br>2. Safety outcomes <br/ ><br>-Severe side effects (defined as a side effect that forced the patient to stop the treatment), <br/ ><br>-mild to moderate side effects. <br/ ><br>3. Qualitative outcomes <br/ ><br>-Impact of leprosy treatment on life <br/ ><br>-Perspective towards leprosy treatment <br/ ><br>-Cost of treatment <br/ ><br> <br/ ><br>Timepoint: 1. Immunological outcomes - 12 mons <br/ ><br>2.Safety outcomes - 12 mons <br/ ><br>3. Qualitative outcomes <br/ ><br>Impact of leprosy treatment on life - 12 mons <br/ ><br>-Perspective towards leprosy treatment <br/ ><br>-Cost of treatment <br/ ><br>