Actively Recruiting
Precision Rifampin Trial for Personalized Dosing
Led by University of Virginia · Updated on 2026-01-27
200
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
Sponsors
U
University of Virginia
Lead Sponsor
R
Rutgers University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Precision Rifampin Trial for Personalized Dosing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 3 years or older
- Diagnosed with active, rifampin-susceptible pulmonary tuberculosis confirmed by sputum or culture, or meeting clinical case definitions for children unable to produce sputum
- Starting combination anti-TB therapy with isoniazid, rifampin, pyrazinamide, and ethambutol
- Participant or guardian able to provide informed consent; children age 7 or older able to provide assent
- Willingness to comply with all trial procedures and available for full duration of the trial
- Resident within a defined geographic area to ensure clinic follow-up
You will not qualify if you...
- Urinary incontinence or very low urine output complicating urine collection
- Kidney disease with glomerular filtration rate (GFR) less than 60 mL/min
- Severe anemia with hemoglobin less than 7 g/dL
- Elevated liver function tests at DAIDS grade 3 or higher (ALT or AST 5 times above normal)
- Pregnancy or childbearing potential without effective contraception
- Weight less than 10.0 kg
- Current treatment with drugs known to significantly interact with anti-TB therapy
- Excessive alcohol use based on defined weekly or daily limits or investigator discretion
AI-Screening
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Trial Site Locations
Total: 1 location
1
Haydom Lutheran Hospital
Haydom, Tanzania
Actively Recruiting
Research Team
S
Scott Heysell, MD, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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