Platform for Assessment of TB Treatment Outcomes - An Observational Study of Individuals Treated for Pulmonary Tuberculosis (TBTC Study 36)
Information:
Sponsor - U.S. Centers for Disease Control & Prevention (200-2009-32598)
Principal Investigator - John L. Johnson, MD, CWRU
| Type of Study | Prospective , observational study |
|---|---|
| Epidemiologic Design | Multi-center , observational study |
| Project Site | Kampala, Uganda |
| Sample Size | 1,000 participants, all study sites, enrolling individuals with culture-confirmed, rifamycin-sensitive pulmonary TB |
| Study Period | Individual participant duration of follow-up: 12 months following completion of TB treatment |
Goal of Study:
This is a prospective observational study that will enroll individuals with suspected pulmonary TB and follow those with culture-confirmed, rifamycin-sensitive TB for 18 months, from the initiation of TB treatment and for 12 months after completion of TB treatment, to collect and analyze sputum to define optimal methods to detect and quantify MTB during treatment; to assess the outcomes of treatment failure, cure, relapse, and death in a standardized manner; and to assess sputum parameters as surrogate markers for these outcomes.
Primary Objectives:
- Determine the optimal methods for detection and quantification of M. tuberculosis (MTB) in sputum over the course of TB treatment
- Assess outcomes of TB treatment (treatment failure, cure, relapse and death) in a rigorous and standardized manner
- Assess sputum parameters as surrogate markers for outcomes of TB treatment
Secondary Objectives:
- To evaluate the safety of the investigational regimens
- To evaluate the tolerability of the investigational regimens
- To collect and assess biospecimens from consenting participants for the purpose of research on discovery and validation of TB biomarkers
- To determine the correlation of mycobacterial and clinical markers with time to culture conversion, culture status at completion of eight weeks of treatment, treatment failure, and relapse.
- To conduct a pharmacokinetic/pharmacodynamic (PK/PD) study of the test drugs. The main objectives of the PK/PD study are to characterize study drug PK parameters and to determine relationships between treatment outcomes and PK parameters.
- To evaluate the pharmacokinetics of efavirenz-based antiretroviral treatment among patients with TB/HIV co-infection taking efavirenz-based combination antiretroviral therapy and TB treatment with rifapentine