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Precision Rifampin Trial for Personalized Dosing (P-RIF)
Individual pharmacokinetic variability is an important driver of tuberculosis (TB) treatment failure particularly among undernourished populations, and that suboptimal serum drug concentrations are associated with delayed response to treatment, death, and acquired bacterial drug resistance. Serum drug exposures can be approximated by urine excretion as measured by spectrophotometry, replacing the need for specialized equipment for serum testing. Anti-TB pharmacokinetic variability has also been associated with enteric pathogen burden. The overall hypothesis is that urine spectrophotometry will identify people with below-target rifampin serum concentrations, which can be corrected to target levels after dose adjustment as confirmed by serum mass spectrometry. Therefore, this protocol includes a clinical trial to assess efficacy and safety of rifampin dose adjustment based on urinary excretion levels among adults and children who are being treated for drug-sensitive pulmonary TB at our longstanding collaborative research site in Haydom Lutheran Hospital, Tanzania.
Details
| Lead sponsor | University of Virginia |
|---|---|
| Phase | PHASE1 |
| Status | RECRUITING |
| Enrolment | 200 |
| Start date | Wed Oct 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Thu Jun 01 2028 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Tuberculosis
Interventions
- urine spectrophotometry for rifampin absorbance
Countries
Tanzania