Trial no.:
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PACTR202007736854169 |
Date of Approval:
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03/07/2020 |
Trial Status:
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Registered in accordance with WHO and ICMJE standards |
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TRIAL DESCRIPTION |
Public title
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Effect of N-acetylcysteine to reduce occurrence of adverse drug reactions in patients receiving multi drug resistant tuberculosis in Tanzania |
Official scientific title |
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. |
Brief summary describing the background
and objectives of the trial
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Background: Adverse drug reactions such as hearing loss or hepatotoxicity is one of the commonly unwanted and highly morbid events occurring in patients using second-line anti-TB medicine. In recent years, the number of multidrug resistant tuberculosis (MDR-TB) patients enrolling for treatment with second-line anti-TB regimen has increased gradually. Therefore, we anticipate that the number of individuals developing hearing loss or renal or hepatic failure post MDR-TB treatment will considerably increase in the foreseeable future, and that any form of prevention of with a currently approved accessible medication is highly relevant.
Aims and Objectives: Investigate the use of a promising antidote, N-acetylcysteine (NAC), in combination with second line anti-TB regimen in slowing the rate of adverse drug events and protecting against the development of permanent and profound disability. NAC will be assessed at dose of 900mg daily or 900mg twice daily for safety and tolerability, efficacy in protecting the ototoxicity and interactions with second line anti-TB drugs. Furthermore, the effect of NAC in different parameters such as clinical and immunological responses, radiographic changes and clearance of Mycobacterium tuberculosis will also be evaluated. |
Type of trial |
RCT |
Acronym (If the trial has an acronym then please provide) |
NAC TRIAL |
Disease(s) or condition(s) being studied |
Infections and Infestations |
Sub-Disease(s) or condition(s) being studied |
Tuberculosis |
Purpose of the trial |
Treatment: Other |
Anticipated trial start date |
30/06/2020 |
Actual trial start date |
31/07/2020 |
Anticipated date of last follow up |
15/07/2022 |
Actual Last follow-up date |
31/07/2022 |
Anticipated target sample size (number of participants) |
60 |
Actual target sample size (number of participants) |
66 |
Recruitment status |
Recruiting |
Publication URL |
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