N/A
N=303
The Impact of Alcohol Consumption on Tuberculosis Treatment Outcomes
Tuberculosis · Alcohol Consumption · Treatment Adverse Effect
Bottom Line
View on ClinicalTrials.gov: NCT02840877 ↗Enrolled (actual)
303
Serious AEs
3.3%
Results posted
Aug 2023
Primary outcome: Primary: Time to Culture Conversion — 5.6; 5.4; 5.5 weeks
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- DOT Adherence Monitoring (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- Boston Medical Center
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Culture Conversion |
5.6; 5.4; 5.5 | — |
| PRIMARY Cmax |
5.29; 1.63; 28.5; 1.98 | — |
| PRIMARY Area Under Curve (AUC) |
22.2; 6.32; 259; 13.2 | — |
| SECONDARY Poor Treatment Outcome |
246; 24; 19; 11 | — |
| SECONDARY Side Effects to TB Drugs |
154; 146 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02840877). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.