Adverse drug reactions in multi-drug resistant pulmonary tuberculosis patients receiving Bedaquiline containing shorter oral regimen: Post marketing surveillance & assessment

Government Medical College, Patiala0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年6月26日

试验速览

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•1)Patients above the age of 18 years
•2)Patients diagnosed with Multidrug resistant pulmonary tuberculosis (Rifampicin resistance detected/inferred; MDR-TB with H resistance detected/inferred based on InhA mutation only or based on KatG mutation only (not both); MDR-TB with FQ resistance not detected)
•3)Those who will understand the purpose of the study, ready to provide information regarding their health status and written informed consent for participation in the study.

•1)Pregnant and lactating women
•2)History of exposure for more than 1 month to Bedaquiline, Levofloxacin, Ethionamide or Clofazimine
•3)Patients with H resistance detected with both KatG and InhA mutation; and patients with FQ resistance detected
•4)Confirmed resistance to a medicine in the shorter oral Bedaquiline- containing MDR-TB regimen
•5)History of Torsade de Pointes, congenital long QT syndrome, uncompensated heart failure, and cardio ventricular arrythmias
•6)Intolerance to any drug in the regimen or risk of toxicity from a drug in shorter oral Bedaquiline- containing MDR-TB regimen
•7)Extra-pulmonary TB disease
•8)Extensive TB disease found in presence of bilateral cavitary disease or extensive parenchymal damage on chest radiography
•9)Reactive Serology for HIV

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