Health Condition 1: A304- Borderline lepromatous leprosy Health Condition 2: A305- Lepromatous leprosy
Conditions
Interventions
Intervention1: alternate Leprosy treatment: ALT (Tablet Minocycline 100 mg + Tablet ofloxacin 400mg and Tab Clarithromycin 500 mg/ Tab clofaziine 50mg daily once a day by oral route for 12 months).
Sponsors
ICMR
Eligibility
Inclusion criteria
Inclusion criteria: All untreated patients with multibacillary leprosy (BI >2) with age >18 years 2. Treated leprosy patients with suspected MB (positive SSS) relapse. 3. Leprosy patients with positive morphological index (MI)/ presence of viable bacilli by RT PCR after completion of 12 monthsMDT MBR.
Exclusion criteria
Exclusion criteria: 1. Paucibacillary leprosy patients ( negative SSS) 2. Pure neuritic leprosy patients 3. Pregnant and lactating mothers 4. Patients allergic OR with contraindications to tetracyclines, clofazimine, ofloxacin 5. Patients co infected with HIV, Hepatitis B and Hepatitis C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To compare the effectiveness of two regimes in decreasing the bacterial load by quantitativePCR at baseline and at the end of treatment 2. To compare serological improvement by measurement of anti PGL-1 antibodies at baseline andend of treatment 3. Comparison of number of episodes of reactions and neuritis during and after treatment in thetwo groups (MBR-MDT vs ALT) Timepoint: baseline ( pretreatment), at 12 months or post treatment and 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| SECONDARY OBJECTIVES 1. To compare frequency of adverse events for patients in each treatment arm Timepoint: baseline, 6 months, 12 months, 24 months | — |
Countries
India
Contacts
Public ContactTarun Narang
Postgraduate Institute of Medical Education and Research, Chandigarh
Outcome results
None listed