The Impact of Alcohol Consumption on Tuberculosis Treatment Outcomes

NCT02840877 | Completed Results

• 2 other identifiers: H-349701R01AI119037-01A1
• Study Type: interventional
• Target: 303
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis; Alcohol Consumption; Treatment Adverse Effect

Keywords

tuberculosis culture; alcohol use

Outcome Measures

Primary Outcomes (3)

• Time to Culture Conversion

  Time to sterilization/culture conversion during the first twelve weeks of treatment in patients with problem alcohol use compared to those without

  12 weeks

• Cmax

  Peak concentrations (Cmax) of isoniazid, rifampin, pyrazinamide, and ethambutol in patients with problem alcohol use compared to those without

  4 weeks

• Area Under Curve (AUC)

  Individual patient steady state 24-hour area under curve (AUC) of isoniazid, rifampin, pyrazinamide, and ethambutol

  4 weeks

Secondary Outcomes (2)

• Poor Treatment Outcome

  18 months

• Side Effects to TB Drugs

  6 months

Study Arms (1)

DOT Adherence Monitoring

OTHER

Daily adherence monitoring by study-employed directly observed therapy (DOT) worker on weekdays throughout the course of TB therapy

Behavioral: DOT Adherence Monitoring

Interventions

DOT Adherence Monitoring BEHAVIORAL

Study participants will meet with a study-employed DOT worker daily during weekdays throughout the course of their TB treatment

DOT Adherence Monitoring

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Boston Medical Center: lead
• Medical Research Council, South Africa: collaborator
• Boston University: collaborator
• University of Cape Town: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• University of Stellenbosch: collaborator

Study Sites (1)

Worcester Community Day Centre

Worcester, Western Cape, South Africa

Location

Related Publications (3)

• Overbeck V, Malatesta S, Carney T, Myers B, Parry CDH, Horsburgh CR, Theron D, White LF, Warren RM, Jacobson KR, Bouton TC. Understanding the impact of pandemics on long-term medication adherence: directly observed therapy in a tuberculosis treatment cohort pre- and post-COVID-19 lockdowns. BMC Infect Dis. 2024 Oct 14;24(1):1154. doi: 10.1186/s12879-024-09994-7.

  PMID: 39396938 DERIVED

• Ragan EJ, Gill CJ, Banos M, Bouton TC, Rooney J, Horsburgh CR, Warren RM, Myers B, Jacobson KR. Directly Observed Therapy to Measure Adherence to Tuberculosis Medication in Observational Research: Protocol for a Prospective Cohort Study. JMIR Res Protoc. 2021 Jun 16;10(6):e24510. doi: 10.2196/24510.

  PMID: 34132642 DERIVED

• Myers B, Bouton TC, Ragan EJ, White LF, McIlleron H, Theron D, Parry CDH, Horsburgh CR, Warren RM, Jacobson KR. Impact of alcohol consumption on tuberculosis treatment outcomes: a prospective longitudinal cohort study protocol. BMC Infect Dis. 2018 Sep 29;18(1):488. doi: 10.1186/s12879-018-3396-y.

  PMID: 30268101 DERIVED

MeSH Terms

Conditions

Tuberculosis; Alcohol Drinking

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Drinking Behavior; Behavior

Results Point of Contact

• Title: Karen Jacobson, MD MPH
• Organization: Boston Medical Center

karen.jacobson@bmc.org

617-414-5213

Study Officials

• Karen Jacobson, MD MPH

  Boston Medical Center, Department of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: July 21, 2016
• Study Start: May 16, 2017
• Primary Completion: June 28, 2022
• Study Completion: October 12, 2023
• Last Updated: August 27, 2024
• Results First Posted: August 14, 2023

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)