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COMPLETED

Urine Colorimetry for Tuberculosis Pharmacokinetics Evaluation in Children and Adults

NCT05283967 · View on ClinicalTrials.gov ↗

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 Studied

Interventions

  • DIAGNOSTIC_TEST urine colorimetric assay

Study Locations (2)

New Jersey

  • Rutgers, The State University of New Jersey — Newark

Virginia

  • University of Virginia — Charlottesville

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2019-01-01
Est. Completion 2023-12-01

Sponsor

University of Virginia

392 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05283967

The ClinicalTrials.gov registry entry for NCT05283967 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Virginia, which has 392 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Tuberculosis appearing as the primary indexed condition, and to 1 intervention — of which urine colorimetric assay is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05283967 reports 2 study locations spanning 2 distinct geographic areas — top geographies include New Jersey, Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05283967 about?

NCT05283967 is a clinical study titled "Urine Colorimetry for Tuberculosis Pharmacokinetics Evaluation in Children and Adults". 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 ...

What is the current status of trial NCT05283967?

This trial is currently completed. The enrollment target is 150 participants. The study started on 2019-01-01. Estimated completion is 2023-12-01.

What conditions does trial NCT05283967 study?

This clinical trial studies the following conditions: Tuberculosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05283967?

The interventions under investigation include: urine colorimetric assay (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05283967?

This trial is sponsored by University of Virginia, which has 392 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05283967 being conducted?

This trial has 2 study locations across New Jersey, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial