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NCT03559582
Diagnostics and Pharmacotherapy for Severe Forms of TB (DMID 15-0100)
trial in Tuberculosis in 478 participants. Completed in 31 January 2021.
31 July 2020
Quick facts
| Lead sponsor | University of Virginia |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 478 |
| Start date | 28 April 2016 |
| Primary completion | 31 July 2020 |
| Estimated completion | 31 January 2021 |
Conditions studied
- Tuberculosis — all drugs for Tuberculosis →
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):
-
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT03559582
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03559582 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Virginia
- Last refreshed: 9 March 2022
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