NCT05283967Completed
Urine Colorimetry for Tuberculosis Pharmacokinetics Evaluation in Children and Adults
Source: ClinicalTrials.gov · Last updated 8 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 150 (actual)
- First submitted
- 8 Mar 2022
- Start date
- 1 Jan 2019
- Primary completion date
- 30 Dec 2022
- Lead sponsor
- University of Virginia
- Diseases
- Tuberculosis
- NCT number
- NCT05283967
What you commit to
- Study type: Observational
- Participants enrolled: 150
- From 1 Jan 2019 to the primary completion date, 30 Dec 2022
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Anuric (i.e. not capable of producing urine due to chronic renal disease);
Other
- Pregnancy or breastfeeding;
- Prisoners
Who the study is looking for
- 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.
Age in the registry: 4 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Rutgers, The State University of New Jersey Coordinator of this site? Confirm its status | Newark | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.