Impact of alcohol consumption on tuberculosis treatment outcomes: A prospective longitudinal cohort study protocol
Background: An estimated 10% of tuberculosis (TB) deaths are attributable to problematic alcohol use globally, however the causal pathways through which problem alcohol use has an impact on TB treatment outcome is not clear. This study aims to improve understanding of these mechanisms. Specifically,...
| Main Authors: | , , , , , , , , , |
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| Format: | Journal Article |
| Language: | English |
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BMC
2018
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| Online Access: | http://hdl.handle.net/20.500.11937/85650 |
| _version_ | 1848764757102821376 |
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| author | Myers-Franchi, Bronwyn Bouton, T.C. Ragan, E.J. White, L.F. McIlleron, H. Theron, D. Parry, C.D.H. Horsburgh, C.R. Warren, R.M. Jacobson, K.R. |
| author_facet | Myers-Franchi, Bronwyn Bouton, T.C. Ragan, E.J. White, L.F. McIlleron, H. Theron, D. Parry, C.D.H. Horsburgh, C.R. Warren, R.M. Jacobson, K.R. |
| author_sort | Myers-Franchi, Bronwyn |
| building | Curtin Institutional Repository |
| collection | Online Access |
| description | Background: An estimated 10% of tuberculosis (TB) deaths are attributable to problematic alcohol use globally, however the causal pathways through which problem alcohol use has an impact on TB treatment outcome is not clear. This study aims to improve understanding of these mechanisms. Specifically, we aim to 1) assess whether poor TB treatment outcomes, measured as delayed time-to-culture conversion, are associated with problem alcohol use after controlling for non-adherence to TB pharmacotherapy; and 2) to determine whether pharmacokinetic (PK) changes in those with problem alcohol use are associated with delayed culture conversion, higher treatment failure/relapse rates or with increased toxicity.
Methods: Our longitudinal, repeated measures, prospective cohort study aims to examine the associations between problem alcohol use and TB treatment outcomes and to evaluate the effect of alcohol on the PK and pharmacodynamics (PD) of TB drugs. We will recruit 438 microbiologically confirmed, pulmonary TB patients with evidence of rifampicin susceptibility in Worcester, South Africa with 200 HIV uninfected patients co-enrolled in the PK aim. Participants are followed for the six months of TB treatment and an additional 12 months thereafter, with sputum collected weekly for the first 12 weeks of treatment, alcohol consumption measures repeated monthly in concert with an alcohol biomarker (phosphatidylethanol) measurement at baseline, and in person directly observed therapy (DOT) using real-time mobile phone-based adherence monitoring. The primary outcome is based on time to culture conversion with the second objective to compare PK of first line TB therapy in those with and without problem alcohol use.
Discussion: Globally, an urgent need exists to identify modifiable drivers of poor TB treatment outcomes. There is a critical need for more effective TB treatment strategies for patients with a history of problem alcohol use. However, it is not known whether poor treatment outcomes in alcohol using patients are solely attributable to noncompliance. This study will attempt to answer this question and provide guidance for future TB intervention trials. Trial registration: Clinicaltrials.gov Registration Number: NCT02840877. Registered on 19 July 2016. |
| first_indexed | 2025-11-14T11:24:25Z |
| format | Journal Article |
| id | curtin-20.500.11937-85650 |
| institution | Curtin University Malaysia |
| institution_category | Local University |
| language | English |
| last_indexed | 2025-11-14T11:24:25Z |
| publishDate | 2018 |
| publisher | BMC |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | curtin-20.500.11937-856502021-10-21T05:11:41Z Impact of alcohol consumption on tuberculosis treatment outcomes: A prospective longitudinal cohort study protocol Myers-Franchi, Bronwyn Bouton, T.C. Ragan, E.J. White, L.F. McIlleron, H. Theron, D. Parry, C.D.H. Horsburgh, C.R. Warren, R.M. Jacobson, K.R. Science & Technology Life Sciences & Biomedicine Infectious Diseases Tuberculosis Mycobacterium tuberculosis Alcohol Pharmacokinetics Treatment adherence Treatment outcome MULTIDRUG-RESISTANT TUBERCULOSIS WESTERN CAPE PROVINCE INTESTINAL-ABSORPTION CIPROFLOXACIN ANALOGS IN-SITU PHARMACOKINETICS HIV ACETYLATION IMMUNITY ETHANOL Background: An estimated 10% of tuberculosis (TB) deaths are attributable to problematic alcohol use globally, however the causal pathways through which problem alcohol use has an impact on TB treatment outcome is not clear. This study aims to improve understanding of these mechanisms. Specifically, we aim to 1) assess whether poor TB treatment outcomes, measured as delayed time-to-culture conversion, are associated with problem alcohol use after controlling for non-adherence to TB pharmacotherapy; and 2) to determine whether pharmacokinetic (PK) changes in those with problem alcohol use are associated with delayed culture conversion, higher treatment failure/relapse rates or with increased toxicity. Methods: Our longitudinal, repeated measures, prospective cohort study aims to examine the associations between problem alcohol use and TB treatment outcomes and to evaluate the effect of alcohol on the PK and pharmacodynamics (PD) of TB drugs. We will recruit 438 microbiologically confirmed, pulmonary TB patients with evidence of rifampicin susceptibility in Worcester, South Africa with 200 HIV uninfected patients co-enrolled in the PK aim. Participants are followed for the six months of TB treatment and an additional 12 months thereafter, with sputum collected weekly for the first 12 weeks of treatment, alcohol consumption measures repeated monthly in concert with an alcohol biomarker (phosphatidylethanol) measurement at baseline, and in person directly observed therapy (DOT) using real-time mobile phone-based adherence monitoring. The primary outcome is based on time to culture conversion with the second objective to compare PK of first line TB therapy in those with and without problem alcohol use. Discussion: Globally, an urgent need exists to identify modifiable drivers of poor TB treatment outcomes. There is a critical need for more effective TB treatment strategies for patients with a history of problem alcohol use. However, it is not known whether poor treatment outcomes in alcohol using patients are solely attributable to noncompliance. This study will attempt to answer this question and provide guidance for future TB intervention trials. Trial registration: Clinicaltrials.gov Registration Number: NCT02840877. Registered on 19 July 2016. 2018 Journal Article http://hdl.handle.net/20.500.11937/85650 10.1186/s12879-018-3396-y English http://creativecommons.org/licenses/by/4.0/ BMC fulltext |
| spellingShingle | Science & Technology Life Sciences & Biomedicine Infectious Diseases Tuberculosis Mycobacterium tuberculosis Alcohol Pharmacokinetics Treatment adherence Treatment outcome MULTIDRUG-RESISTANT TUBERCULOSIS WESTERN CAPE PROVINCE INTESTINAL-ABSORPTION CIPROFLOXACIN ANALOGS IN-SITU PHARMACOKINETICS HIV ACETYLATION IMMUNITY ETHANOL Myers-Franchi, Bronwyn Bouton, T.C. Ragan, E.J. White, L.F. McIlleron, H. Theron, D. Parry, C.D.H. Horsburgh, C.R. Warren, R.M. Jacobson, K.R. Impact of alcohol consumption on tuberculosis treatment outcomes: A prospective longitudinal cohort study protocol |
| title | Impact of alcohol consumption on tuberculosis treatment outcomes: A prospective longitudinal cohort study protocol |
| title_full | Impact of alcohol consumption on tuberculosis treatment outcomes: A prospective longitudinal cohort study protocol |
| title_fullStr | Impact of alcohol consumption on tuberculosis treatment outcomes: A prospective longitudinal cohort study protocol |
| title_full_unstemmed | Impact of alcohol consumption on tuberculosis treatment outcomes: A prospective longitudinal cohort study protocol |
| title_short | Impact of alcohol consumption on tuberculosis treatment outcomes: A prospective longitudinal cohort study protocol |
| title_sort | impact of alcohol consumption on tuberculosis treatment outcomes: a prospective longitudinal cohort study protocol |
| topic | Science & Technology Life Sciences & Biomedicine Infectious Diseases Tuberculosis Mycobacterium tuberculosis Alcohol Pharmacokinetics Treatment adherence Treatment outcome MULTIDRUG-RESISTANT TUBERCULOSIS WESTERN CAPE PROVINCE INTESTINAL-ABSORPTION CIPROFLOXACIN ANALOGS IN-SITU PHARMACOKINETICS HIV ACETYLATION IMMUNITY ETHANOL |
| url | http://hdl.handle.net/20.500.11937/85650 |