NCT04271397 (OPTI-4TB) is a NA clinical trial of Multiple blood samples in Tuberculosis, sponsored by Hospices Civils de Lyon.

Who is sponsoring NCT04271397?

NCT04271397 is sponsored by Hospices Civils de Lyon.

What drugs are being tested in NCT04271397?

Interventions in NCT04271397: Multiple blood samples, Single blood sample.

What condition does NCT04271397 study?

NCT04271397 studies Tuberculosis, Tuberculosis Infection.

Is NCT04271397 still recruiting?

NCT04271397 is currently recruiting now. Last updated 12 August 2024.

Last reviewed 2024-08-12 · How we verify

NCT04271397: OPTI-4TB

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Immunological Biomarkers in Tuberculosis Management

Recruiting now NA Last updated 12 August 2024

What this trial tests

NA trial testing Multiple blood samples in Tuberculosis in 60 participants. Currently enrolling.

Timeline

30 September 2019

Primary endpoint
10 September 2026

10 October 2026

Quick facts

Lead sponsor	Hospices Civils de Lyon
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	60
Start date	30 September 2019
Primary completion	10 September 2026
Estimated completion	10 October 2026
Sites	1 location across France

Drugs / interventions tested

Multiple blood samples
Single blood sample

Conditions studied

Tuberculosis — all drugs for Tuberculosis →
Tuberculosis Infection — all drugs for Tuberculosis Infection →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

18 and older, any sex, with Tuberculosis or Tuberculosis Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Tuberculosis (TB) is the leading cause of death by infectious disease in the world, responsible for 1.6 million deaths in 2017. The treatment of active TB requires at least a 6-month combined antibiotic regimen and can cause heavy side effects. As a consequence, treatment adherence is not optimal, particularly in primary care settings. Rapid and reliable monitoring of anti-TB treatment adherence and efficacy is critical to provide adequate patient care and curb relapse episodes and acquired drug resistance. Investigators propose to evaluate the performance in terms of diagnosis accuracy and outcome prediction of four new biomarkers of active TB: 1) a double IGRA (Interferon Gamma Release Assay) including QuantiFERON-Gold Plus® and HBHA; 2) a whole blood transcriptomic analysis of mRNA (messenger Ribonucleic acid) expression of a panel of 150 genes; 3) a whole blood proteomic analysis; 4) an ex vivo immunophenotyping using flow and mass cytometry to characterize the lymphocyte populations.

Publications & conference data

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

Opti-4TB: A protocol for a prospective cohort study evaluating the performance of new biomarkers for active tuberculosis outcome prediction.
Bahuaud O, Genestet C, Hoffmann J, Dumitrescu O, et al · · 2022 · cited 3× · PMID 36186786 · DOI 10.3389/fmed.2022.998972
Exposure to Rifampicin and its Metabolite 25-Deacetylrifampicin Rapidly Decreases During Tuberculosis Therapy.
Goutelle S, Bahuaud O, Genestet C, Millet A, et al · · 2025 · cited 1× · PMID 39871048 · DOI 10.1007/s40262-025-01479-3

Verify or expand the search:

Other recruiting trials for Tuberculosis

Currently open trials in the same condition.

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NCT06318416 — Precision Rifampin Trial for Personalized Dosing · Phase 1 · recruiting
NCT07170800 — A Phase 2b Clinical Study of JDB0131 Benzenesulfonate Tablets · Phase 2 · recruiting

Other Hospices Civils de Lyon trials

Trials by the same sponsor.

NCT07569536 — Efficacy of the Alpha 2 Agonist Dexmedetomidine for Sympathetic Deactivation in REfractory Septic Shock · Phase 3 · not yet recruiting
NCT07529314 — Evaluating Interventional Radiology for Cancer Pain Management · NA · not yet recruiting
NCT07273929 — Comparative Study of the Effectiveness of Three Access Routes for Implanting an Electronic Intracardiac Device · Phase 3 · not yet recruiting
NCT07474532 — Attitudes and Beliefs Related to Benzodiazepine Deprescribing · not yet recruiting
NCT07313007 — Assessment of Gut Microbiota-Derived Amino Acid Metabolite Production in Patients With MASLD · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04271397 (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 Hospices Civils de Lyon
Last refreshed: 12 August 2024

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/NCT04271397.

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