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 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•1. Adult patients of either sex diagnosed with multibacillary leprosy.
•2. Patients with persistent/new lesions after completing Ã¢â?°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 Ã¢â?°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.

•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.

发起方

Prof Nusrat Shafiq