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NCT05283967: PEE-TB
Urine Colorimetry for Tuberculosis Pharmacokinetics Evaluation in Children and Adults
trial testing urine colorimetric assay in Tuberculosis in 150 participants. Completed in 1 December 2023.
30 December 2022
Quick facts
| Lead sponsor | University of Virginia |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 150 |
| Start date | 1 January 2019 |
| Primary completion | 30 December 2022 |
| Estimated completion | 1 December 2023 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- urine colorimetric assay
Conditions studied
- Tuberculosis — all drugs for Tuberculosis →
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):
-
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 -
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:
- PubMed search for NCT05283967
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05283967 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Virginia
- Last refreshed: 8 May 2024
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