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Urine Colorimetry for Tuberculosis Pharmacokinetics Evaluation in Children and Adults

NCT05283967 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2024-05-08

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

urine colorimetric assay

Colorimetric assays will be performed for urine drug concentrations of rifampin, isoniazid and pyrazinamide from urine collected throughout one dosing interval. Assay results will experimental only and not used to change patient care.

Sponsors & Collaborators

  • Rutgers, The State University of New Jersey

    collaborator OTHER

  • University of Florida

    collaborator OTHER

  • University of Virginia

    lead OTHER

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2022-12-30
Completion
2023-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05283967 on ClinicalTrials.gov