Phase 2b open label randomized controlled trial to evaluate the adverse drug reaction protective efficacy, safety and tolerability of N-acetylcysteine in combination with second-line in adult subjects treated for multidrug-resistant tuberculosis in Tanzania.

Stellah Mpagama0 个研究点目标入组 60 人开始时间: 2020年6月20日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•1.A patient is able and willing to provide written informed consent prior to any trial procedure
•2.Patient is aged between 18 – 65 years
•3.Patient is a newly diagnosed with MDR-TB and not started MDR-TB treatment
•4.Patient is eligible for aminoglycoside or bedaquiline based second-line anti-TB drugs
•5.Karnofsky score of ? 50
•6.Female patient should not be pregnant confirmed by urinary pregnant test (UPT)

•1.Patient has pre-existing profound hearing loss at dB >90
•2.Patient has a history of using secondline anti-TB drugs
•3.Patient has previous or existing pathology of the external or middle ear which would preclude auditory testing
•4.Patient has previous or existing pathology of the inner ear with or without hearing loss (i.e. sudden sensorineural hearing loss, Meniere's disease, autoimmune inner ear disease)
•5.Patient has previous or existing pathology of the central nervous system with potential to impact auditory pathways (i.e. major head trauma, meningitis, encephalitis, brain metastasis, vestibular schwannoma)
•6.Patient has mental disorder such as schizophrenia, schizoaffective disorder or psychotic disorder
•7.Patient is pregnant as indicated by urinary pregnant test (UPT).
•8.Patient has comorbid condition such as severe liver or renal diseases

发起方

Stellah Mpagama