Tuberculosis Clinical Trial
— PEE-TBOfficial title:
Urine Colorimetry for Tuberculosis Pharmacokinetics Evaluation in Children and Adults
NCT number | NCT05283967 |
Other study ID # | 20944 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2019 |
Est. completion date | December 1, 2023 |
Verified date | May 2024 |
Source | University of Virginia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 | Completed |
Enrollment | 150 |
Est. completion date | December 1, 2023 |
Est. primary completion date | December 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years and older |
Eligibility | Inclusion Criteria: 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. Exclusion Criteria: - Anuric (i.e. not capable of producing urine due to chronic renal disease); - Pregnancy or breastfeeding; - Prisoners |
Country | Name | City | State |
---|---|---|---|
United States | University of Virginia | Charlottesville | Virginia |
United States | Rutgers, The State University of New Jersey | Newark | New Jersey |
Lead Sponsor | Collaborator |
---|---|
University of Virginia | Rutgers, The State University of New Jersey, University of Florida |
United States,
Szipszky C, Van Aartsen D, Criddle S, Rao P, Zentner I, Justine M, Mduma E, Mpagama S, Al-Shaer MH, Peloquin C, Thomas TA, Vinnard C, Heysell SK. Determination of Rifampin Concentrations by Urine Colorimetry and Mobile Phone Readout for Personalized Dosing in Tuberculosis Treatment. J Pediatric Infect Dis Soc. 2021 Mar 26;10(2):104-111. doi: 10.1093/jpids/piaa024. — View Citation
Zentner I, Modongo C, Zetola NM, Pasipanodya JG, Srivastava S, Heysell SK, Mpagama S, Schlect HP, Gumbo T, Bisson GP, Vinnard C. Urine colorimetry for therapeutic drug monitoring of pyrazinamide during tuberculosis treatment. Int J Infect Dis. 2018 Mar;68:18-23. doi: 10.1016/j.ijid.2017.12.017. Epub 2017 Dec 15. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Urine Cmax | Urine peak concentration (Cmax) of rifampin as determined by urine colorimetry | Day 1 | |
Primary | Urine rifampin AUC | Urine total rifampin area under the concentration time curve (AUC) as determined by urine colorimetry | Day 1 | |
Primary | Urine isoniazid Cmax | Urine peak concentration (Cmax) of isoniazid as determined by urine colorimetry | Day 1 | |
Primary | Urine isoniazid AUC | Urine total isoniazid area under the concentration time curve as determined by urine colorimetry | Day 1 | |
Primary | Urine pyrazinamide Cmax | Urine peak concentration (Cmax) of pyrazinamide as determined by urine colorimetry | Day 1 | |
Primary | Urine pyrazinamide AUC | Urine total pyrazinamide area under the concentration time curve as determined by urine colorimetry | Day 1 |
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