Last reviewed · How we verify

NCT05283967: PEE-TB

Urine Colorimetry for Tuberculosis Pharmacokinetics Evaluation in Children and Adults

Completed Last updated 8 May 2024
What this trial tests

trial testing urine colorimetric assay in Tuberculosis in 150 participants. Completed in 1 December 2023.

Timeline
1 January 2019
Primary endpoint
30 December 2022
1 December 2023

Quick facts

Lead sponsorUniversity of Virginia
StatusCompleted
Study typeOBSERVATIONAL
Enrollment150
Start date1 January 2019
Primary completion30 December 2022
Estimated completion1 December 2023
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Virginia

Who can join

4 and older, any sex, with Tuberculosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Roadblocks and resilience: A qualitative study of the impact of pediatric tuberculosis on Tanzanian households and solutions from caregivers.
    Petros de Guex K, Augustino D, Mejan P, Gadiye R, et al · · 2023 · cited 6× · PMID 37021699 · DOI 10.1080/17441692.2023.2196569
  2. Duration of Symptoms Prior to Pediatric and Adolescent Tuberculosis Diagnosis and Its Impact on Schooling in Tanzania: A Mixed Methods Study.
    Ilaiwy G, Lukumay S, Augustino D, Mejan P, et al · · 2023 · cited 1× · PMID 37094782 · DOI 10.4269/ajtmh.22-0798

Verify or expand the search:

Other recruiting trials for Tuberculosis

Currently open trials in the same condition.

Other University of Virginia trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05283967.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing