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The Impact of Alcohol Consumption on Tuberculosis Treatment Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborators:
Medical Research Council, South Africa
Boston University
University of Cape Town
National Institute of Allergy and Infectious Diseases (NIAID)
University of Stellenbosch
Information provided by (Responsible Party):
Boston Medical Center

Brief Summary:
After HIV/AIDS, tuberculosis (TB) remains the second leading cause of death due to an infectious disease globally. Retrospective studies from many countries, including the United States and South Africa, have consistently reported that in addition to having a higher burden of TB disease, patients with problem alcohol use have worse TB treatment outcomes. This prospective study will attempt to clarify both behavioral and biologic causal mechanisms underlying the deleterious effects of problem alcohol use on TB treatment response.

Condition or disease Intervention/treatment Phase
Tuberculosis Alcohol Consumption Treatment Adverse Effect Behavioral: DOT Adherence Monitoring Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 438 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol Tuberculosis

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. at least 15 years old
  2. initiating TB treatment in South Africa
  3. expect to remain in the local area for the next 2 years
  4. agree to comply with all study requirements, including provision of contact information and attendance at all study appointments
  5. provide written, informed consent to participate in the study if ≥18 years of age or written assent and parental consent if <18 years.

Exclusion Criteria:

  1. they have multidrug-resistant (MDR) TB (RIF resistance will be known at screening from Xpert MTB/RIF)
  2. they have a contra-indication to start on standard 4-drug therapy
  3. they are pregnant at study enrollment
  4. they are HIV seropositive for aim 2 only

Information from the National Library of Medicine

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


Locations
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South Africa
Worcester Community Day Centre
Worcester, Western Cape Province, South Africa
Sponsors and Collaborators
Boston Medical Center
Medical Research Council, South Africa
Boston University
University of Cape Town
National Institute of Allergy and Infectious Diseases (NIAID)
University of Stellenbosch
Investigators
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Principal Investigator: Karen Jacobson Boston Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT02840877    
Other Study ID Numbers: H-34970
1R01AI119037-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston Medical Center:
tuberculosis culture
alcohol use
Additional relevant MeSH terms:
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Tuberculosis
Alcohol Drinking
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Drinking Behavior