Urine Colorimetry for Tuberculosis Pharmacokinetics Evaluation in Children and Adults

NCT05283967 | Completed FDA Drug

• 1 other identifier: 20944
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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

Tuberculosis

Outcome Measures

Primary Outcomes (6)

• Urine Cmax

  Urine peak concentration (Cmax) of rifampin as determined by urine colorimetry

  Day 1

• Urine rifampin AUC

  Urine total rifampin area under the concentration time curve (AUC) as determined by urine colorimetry

  Day 1

• Urine isoniazid Cmax

  Urine peak concentration (Cmax) of isoniazid as determined by urine colorimetry

  Day 1

• Urine isoniazid AUC

  Urine total isoniazid area under the concentration time curve as determined by urine colorimetry

  Day 1

• Urine pyrazinamide Cmax

  Urine peak concentration (Cmax) of pyrazinamide as determined by urine colorimetry

  Day 1

• Urine pyrazinamide AUC

  Urine total pyrazinamide area under the concentration time curve as determined by urine colorimetry

  Day 1

Study Arms (2)

Adults and children, U.S.

A prospective, observational study of the pharmacokinetics of first-line anti-TB drugs (isoniazid, rifampin, and pyrazinamide) among TB patients (i.e. patients with active TB disease) will be conducted.

Diagnostic Test: urine colorimetric assay

Tanzanian children

A prospective, observational study of the pharmacokinetics of first-line anti-TB drugs (isoniazid, rifampin, and pyrazinamide) among TB patients (i.e. patients with active TB disease) will be conducted.

Diagnostic Test: urine colorimetric assay

Interventions

urine colorimetric assay DIAGNOSTIC_TEST

Colorimetric assays will be performed for urine drug concentrations of rifampin, isoniazid and pyrazinamide from urine collected throughout one dosing interval. Assay results will experimental only and not used to change patient care.

Adults and children, U.S.; Tanzanian children

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study personnel will review the daily clinic rosters at each enrollment site to identify patients with TB who have initiated or are planning to initiate first-line anti-TB therapy with a regimen that includes isoniazid, rifampin, and pyrazinamide.

You may qualify if:

• 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.

You may not qualify if:

• Anuric (i.e. not capable of producing urine due to chronic renal disease);
• Pregnancy or breastfeeding;
• Prisoners

Sponsors & Collaborators

• University of Virginia: lead
• Rutgers, The State University of New Jersey: collaborator
• University of Florida: collaborator

Study Sites (2)

Rutgers, The State University of New Jersey

Newark, New Jersey, 07103, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (3)

• 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.

  PMID: 32170944 BACKGROUND

• 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.

  PMID: 29253711 BACKGROUND

• Petros de Guex K, Augustino D, Mejan P, Gadiye R, Massong C, Lukumay S, Msoka P, Sariko M, Kimathi D, Vinnard C, Xie Y, Mmbaga B, Pfaeffle H, Geba M, Heysell SK, Mduma E, Thomas TA. Roadblocks and resilience: A qualitative study of the impact of pediatric tuberculosis on Tanzanian households and solutions from caregivers. Glob Public Health. 2023 Jan;18(1):2196569. doi: 10.1080/17441692.2023.2196569.

  PMID: 37021699 DERIVED

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine, Infectious Diseases and International Health

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 17, 2022
• Study Start: January 1, 2019
• Primary Completion: December 30, 2022
• Study Completion: December 1, 2023
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

US (2)