CTRI/2022/09/045483
Not yet recruiting
未知
A Study to evaluate the efficacy, safety, pharmacokinetics- pharmacodynamics of Bedaquiline based regimen in Multibacillary leprosy not responding to WHO-Multidrug Therapy (MDT MBR).
Prof Nusrat Shafiq0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: A305- Lepromatous leprosy
- Sponsor
- Prof Nusrat Shafiq
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adult patients of either sex diagnosed with multibacillary leprosy.
- •2\. Patients with persistent/new lesions after completing ââ?°Â¥ 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 ââ?°Â¥ 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
- •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.
Outcomes
Primary Outcomes
Not specified
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