Effect of N-acetylcysteine to reduce occurrence of adverse drug reactions in patients receiving multi drug resistant tuberculosis in Tanzania
- Conditions
- Tuberculosis
- Registration Number
- PACTR202007736854169
- Lead Sponsor
- Stellah Mpagama
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Development of clinical or laboratory-based or both adverse events at any frequency during the first six month of MDR-TB treatment
- Secondary Outcome Measures
Name Time Method