Last reviewed · How we verify

NCT03559582

Diagnostics and Pharmacotherapy for Severe Forms of TB (DMID 15-0100)

Completed Last updated 9 March 2022
What this trial tests

trial in Tuberculosis in 478 participants. Completed in 31 January 2021.

Timeline
28 April 2016
Primary endpoint
31 July 2020
31 January 2021

Quick facts

Lead sponsorUniversity of Virginia
StatusCompleted
Study typeOBSERVATIONAL
Enrollment478
Start date28 April 2016
Primary completion31 July 2020
Estimated completion31 January 2021

Conditions studied

Sponsor

University of Virginia

Who can join

Eligibility, any sex, with Tuberculosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Major Research Aim: To study novel molecular diagnostics and the pharmacokinetic variability among a spectrum of TB disease states, including severe forms of TB like disseminated TB, TB meningitis and drug resistant TB, among adults and children from multiple international sites.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. A systematic review and meta-analysis of first-line tuberculosis drug concentrations and treatment outcomes.
    Perumal R, Naidoo K, Naidoo A, Ramachandran G, et al · · 2020 · cited 23× · PMID 32005307 · DOI 10.5588/ijtld.19.0025
  2. Fluoroquinolones in Drug-Resistant Tuberculosis: Culture Conversion and Pharmacokinetic/Pharmacodynamic Target Attainment To Guide Dose Selection.
    Al-Shaer MH, Alghamdi WA, Alsultan A, An G, et al · · 2019 · cited 19× · PMID 31061152 · DOI 10.1128/aac.00279-19
  3. Levofloxacin pharmacokinetics in saliva as measured by a mobile microvolume UV spectrophotometer among people treated for rifampicin-resistant TB in Tanzania.
    Mohamed S, Mvungi HC, Sariko M, Rao P, et al · · 2021 · cited 17× · PMID 33675664 · DOI 10.1093/jac/dkab057
  4. Determination of Rifampin Concentrations by Urine Colorimetry and Mobile Phone Readout for Personalized Dosing in Tuberculosis Treatment.
    Szipszky C, Van Aartsen D, Criddle S, Rao P, et al · · 2021 · cited 16× · PMID 32170944 · DOI 10.1093/jpids/piaa024
  5. Population Pharmacokinetics and Significant Under-Dosing of Anti-Tuberculosis Medications in People with HIV and Critical Illness.
    Rao PS, Moore CC, Mbonde AA, Nuwagira E, et al · · 2021 · cited 15× · PMID 34207312 · DOI 10.3390/antibiotics10060739
  6. Pharmacokinetic-Pharmacodynamic Determinants of Clinical Outcomes for Rifampin-Resistant Tuberculosis: A Multisite Prospective Cohort Study.
    Heysell SK, Mpagama SG, Ogarkov OB, Conaway M, et al · · 2023 · cited 11× · PMID 35731948 · DOI 10.1093/cid/ciac511
  7. Pharmacogenetic testing for NAT2 genotypes in a Tanzanian population across the lifespan to guide future personalized isoniazid dosing.
    Masiphephethu MV, Sariko M, Walongo T, Maro A, et al · · 2022 · cited 10× · PMID 35961094 · DOI 10.1016/j.tube.2022.102246
  8. Enteropathogen spectrum and effect on antimycobacterial pharmacokinetics among children with tuberculosis in rural Tanzania: a prospective cohort study.
    Van Aartsen D, Justine M, Mduma E, Mpagama SG, et al · · 2022 · cited 7× · PMID 35659902 · DOI 10.1016/s2666-5247(21)00308-6

Verify or expand the search:

Other recruiting trials for Tuberculosis

Currently open trials in the same condition.

Other University of Virginia trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT03559582.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing