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NCT06318416

Precision Rifampin Trial for Personalized Dosing

Precision Rifampin (P-RIF) Trial for Personalized Dosing in Active Tuberculosis Disease
University of Virginia·Phase 1/2·ClinicalTrials.gov·diagnostic testNot yet recruiting
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Study focus
Disease/Condition
Tuberculosis
Drug/Device/Intervention
urine spectrophotometry for rifampin absorbance
Study type
Interventional
Intervention type
diagnostic test
Sponsor & location
Primary sponsor
University of Virginia
Timeline & enrollment
Phase
Phase 1/2
Start date
Jul 01, 2024
End date
Jan 30, 2028
Enrollment
200 participants
Primary outcome

Rifampin serum area under the concentration time curve for the 24 hour dosing interval,Adverse events

Summary

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.

ICD-10 classifications
TuberculosisLatent tuberculosisTuberculosis of other organsCongenital tuberculosisSequelae of tuberculosis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06318416
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06318416 through Pure Global AI's free database. This Phase 1/2 trial is sponsored by University of Virginia and is currently Not yet recruiting. The study focuses on Tuberculosis. Target enrollment is 200 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.