Health Condition 1: A305- Lepromatous leprosy
Conditions
Interventions
Intervention1: Bedaquiline based regimen: The bedaquiline based regimen will include bedaquiline, rifampicin and clofazimine. 200mg Bedaquiline once daily for 2 weeks followed by 100 mg tablet thrice
Sponsors
Prof Nusrat Shafiq
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult patients of either sex diagnosed with multibacillary leprosy. 2. Patients with persistent/new lesions after completing = 12 months of WHO-MDT-MBR inspite of proper patient compliance (reactions will be ruled out histopathologically and clinically from these lesions) AND persistent positive/increasing values of the morphological index (MI) and a 2 log increase in the bacteriological index (BI) after = 12 months of WHO-MDT-MBR. 3. If a woman is of child-bearing age, then proper method of birth control should be followed. Both male and female patients must be advised to use birth control methods during the treatment with bedaquiline. 4. Patients Should be willing to give written informed consent. 5. Patients who are willing to comply with the follow-ups and investigations related to the study.
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating mothers. 2. Patients who are allergic to drugs used in the study or have any contraindication for their use 3. Patients with HIV, Hepatitis B, and Hepatitis C. 4. Patients who are not able to come for monthly follow-up visits for 1 year. 5. Patients having tuberculosis, as indicated through X-rays and medical history. 6. Patients with cardiac, hepatic, renal, neurological diseases, mental, cerebrovascular diseases, bleeding disorders, and showing abnormal baseline laboratory parameters.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients achieving clinical cure at 1 year in the bedaquiline based regimen as compared to extended conventional regimen in those not responding to WHO regimen.Timepoint: one year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in clinical score, bacillary index, morphological index from baseline at 12, 24 and 48 weeks. 2.Percentage of adverse events, severe and serious adverse events. Timepoint: 12 weeks,24 weeks and 48 weeks | — |
Countries
India
Contacts
Public ContactProf Samir Malhotra
Postgraduate institute of medical education and research (PGIMER), Chandigarh
Outcome results
None listed