Evaluation of bacteriological and immunological responses induced by MIP and/ BCG vaccines in multibacillary leprosy patients
Not Applicable
- Conditions
- Health Condition 1: A304- Borderline lepromatous leprosyHealth Condition 2: A303- Borderline leprosyHealth Condition 3: A302- Borderline tuberculoid leprosyHealth Condition 4: A305- Lepromatous leprosy
- Registration Number
- CTRI/2020/11/028803
- Lead Sponsor
- ICMR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Treatment naïve cases of MB leprosy classified according to WHO classification.
2. Age group: 12- 60 years
3. Patients willing to give consent (for patients aged 12-18years willing to give assent and consent from the legally acceptable representative)
Exclusion Criteria
Paucibacillary (PB) cases of leprosy
2. Defaulter cases
3. Relapse cases
4. Patients on steroids- prednisolone dose >20mg/day for more than 2 weeks
5. Pregnancy or breast feeding
6. With medical co-morbidities like diabetes, cancer, history of or active pulmonary tuberculosis
7. People living with HIV/AIDS
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Decline in viable bacilli load by quantitative real time PCR (occurrence of persisters) before and after treatment. <br/ ><br>2. To study the changes in immune profile of the patients in three treatment arms. <br/ ><br> Outcome measures to be interpreted as per the findings at every 6-month interval.Timepoint: Baseline, at 6 months, at 12 months, at 24 months
- Secondary Outcome Measures
Name Time Method Assessment of clinical regression, occurrence and severity of reactions and changes in nerve function, histological upgrading.Timepoint: Baseline, at 6 months, at 12 months, at 24 months