The Impact of Alcohol Consumption on Tuberculosis Treatment Outcomes
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|ClinicalTrials.gov Identifier: NCT02840877|
Recruitment Status : Suspended (Currently suspended due to Covid-19 policies.)
First Posted : July 21, 2016
Last Update Posted : April 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Tuberculosis Alcohol Consumption Treatment Adverse Effect||Behavioral: DOT Adherence Monitoring||Not Applicable|
A major knowledge gap is the degree to which poor treatment outcomes in alcohol-abusing patients are due to noncompliance alone. Problem alcohol use impacts on retention in care and adherence to daily TB treatment. Poor medication adherence and increased default from TB care have been documented for patients consuming alcohol regularly in several countries. Yet there has been no research to identify reasons (beyond adherence) for these poorer outcomes among patients with problem alcohol use. A key barrier to understanding the persistent biologic effect of alcohol on TB disease is inadequate data on adherence, including detailed data on daily adherence (or number of missed doses of medication). Research combining better approaches to alcohol ascertainment and adherence monitoring is needed to advance understanding of the pathways by which alcohol use and TB disease interact.
Aim 1: To (i) examine the associations between problem alcohol use and TB treatment outcomes, and (ii) demonstrate that these associations persist independent of adherence to TB treatment.
Aim 2: To evaluate the effect of problem alcohol use on the pharmacokinetics (PK)/pharmacodynamics (PD) of TB drugs.
Culture-positive, pulmonary TB patients will be recruited in Worcester, South Africa, and followed over an 18-month period. Patients will complete an interviewer-administered questionnaire on their alcohol use and other health-related behaviors, and their recent alcohol use will be confirmed using a biomarker (phosphatidylethanol). Chest radiographs, sputum smears and culture, and blood samples will be collected to compare the biology of treatment response in patients with and without problem alcohol use. During the 6-month treatment period, smart mobile-phone technology will be used to document daily drug adherence by trained community workers. Serial measures of alcohol intake and serial sputa isolates will be collected to assess treatment response and TB drug side effects will be recorded. In addition, intensive PK/PD studies of isoniazid, rifampin, ethambutol, and pyrazinamide will be performed in 200 HIV-seronegative patients. The full cohort will be followed for 12 months post-treatment to examine long-term TB outcomes, including relapse and death.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||438 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Impact of Alcohol Consumption on Tuberculosis Treatment Outcomes|
|Actual Study Start Date :||May 16, 2017|
|Estimated Primary Completion Date :||May 2022|
|Estimated Study Completion Date :||May 2022|
DOT Adherence Monitoring
Daily adherence monitoring by study-employed directly observed therapy (DOT) worker on weekdays throughout the course of TB therapy
Behavioral: DOT Adherence Monitoring
Study participants will meet with a study-employed DOT worker daily during weekdays throughout the course of their TB treatment
- Time to culture conversion [ Time Frame: 12 weeks ]Time to sterilization/culture conversion during the first twelve weeks of treatment in patients with problem alcohol use compared to those without
- Cmax and AUC [ Time Frame: 4 weeks ]Peak concentrations (Cmax) and individual patient steady state 24-hour area under curve (AUC) of isoniazid, rifampin, pyrazinamide, and ethambutol in patients with problem alcohol use compared to those without
- Poor treatment outcome [ Time Frame: 18 months ]Risk of poor final TB outcomes (defined as treatment failure, death, or relapse) in patients with problem alcohol use compared to those without
- Side effects to TB drugs [ Time Frame: 6 months ]Percentage of patients who develop side effects to the TB drugs in patients with problem alcohol use compared to those without
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840877
|Worcester Community Day Centre|
|Worcester, Western Cape Province, South Africa|
|Principal Investigator:||Karen Jacobson||Boston Medical Center|