Status:
COMPLETED
Urine Colorimetry for Tuberculosis Pharmacokinetics Evaluation in Children and Adults
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
Rutgers, The State University of New Jersey
University of Florida
Conditions:
Tuberculosis
Eligibility:
All Genders
4+ years
Brief Summary
The purpose of the study is to generate receiver-operating-characteristic (ROC) curves for urine colorimetry to identify tuberculosis (TB) patients (children and adults) with low drug anti-TB drug exp...
Detailed Description
TB remains a leading infectious disease cause-of-death worldwide, with an estimated 1.5 million TB deaths each year. There is wide variability in absorption and metabolism of the anti-TB drugs, and lo...
Eligibility Criteria
Inclusion
- Patients of male and female sex meeting all of these criteria:
- Those 4 years and older;
- Diagnosed with active TB and initiation of combination anti-TB therapy with isoniazid, rifampin, and pyrazinamide, with or without DM;
- Able to provide informed consent and assent for those 7-17 years old.
Exclusion
- Anuric (i.e. not capable of producing urine due to chronic renal disease);
- Pregnancy or breastfeeding;
- Prisoners
Key Trial Info
Start Date :
January 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05283967
Start Date
January 1 2019
End Date
December 1 2023
Last Update
May 8 2024
Active Locations (2)
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1
Rutgers, The State University of New Jersey
Newark, New Jersey, United States, 07103
2
University of Virginia
Charlottesville, Virginia, United States, 22908