NCT03559582

Diagnostics and Pharmacotherapy for Severe Forms of TB (DMID 15-0100)

Diagnostics and Pharmacotherapy for Severe Forms of TB

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 478 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Major Research Aim: To study novel molecular diagnostics and the pharmacokinetic variability among a spectrum of TB disease states, including severe forms of TB like disseminated TB, TB meningitis and drug resistant TB, among adults and children from multiple international sites.

Detailed description

Aim 1. Measure pharmacokinetics to anti-tuberculosis (TB) medications in severe TB syndromes (including multidrug-resistant TB, pediatric TB, TB sepsis and TB meningitis) from diverse geographies (including Tanzania, Uganda, Bangladesh, and Siberia) and correlate these findings to TB treatment outcome (TB treatment failure: death/ default/ relapse/ further acquired drug resistance). Aim 2. Decipher mechanisms of pharmacokinetic variability to TB drugs, particularly malabsorption due to concurrent gastrointestinal disease. Aim 3. Deployment of quantitative susceptibility testing (minimum inhibitory concentration-MIC) and rapid MIC-informed molecular methods (e.g., TaqMan Array Card-TAC) for M. tuberculosis. In addition to the stated aims, the primary elements of capacity building requisite for this project include the training in and deployment of the fieldable molecular diagnostic platforms, onsite pharmacokinetic monitoring, and a broad strengthening of longitudinal cohort management for clinical research.

Conditions

• Tuberculosis

Timeline

• Start date: 2016-04-28
• Primary completion: 2020-07-31
• Completion: 2021-01-31
• First posted: 2018-06-18
• Last updated: 2022-03-09