CompletedNot Applicable

Urine Colorimetry for Tuberculosis Pharmacokinetics Evaluation in Children and Adults

United States150 participantsStarted 2019-01-01

Plain-language 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 exposures, which will define the diagnostic accuracy. The central hypothesis is that urine colorimetry will successfully identify patients with low anti-TB serum drug levels, and do so with diagnostic characteristics similar to other widely used tests in TB management.

Who can participate

Age range4 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 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 Criteria: * Anuric (i.e. not capable of producing urine due to chronic renal disease); * Pregnancy or breastfeeding; * Prisoners

What they're measuring

Urine Cmax

Timeframe: Day 1

Urine rifampin AUC

Timeframe: Day 1

Urine isoniazid Cmax

Timeframe: Day 1

Urine isoniazid AUC

Timeframe: Day 1

Urine pyrazinamide Cmax

Timeframe: Day 1

Urine pyrazinamide AUC

Timeframe: Day 1

Trial details

NCT IDNCT05283967

SponsorUniversity of Virginia

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-30

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