Who is sponsoring NCT04121026?

NCT04121026 is sponsored by Institut National de la Santé Et de la Recherche Médicale, France.

What drugs are being tested in NCT04121026?

Interventions in NCT04121026: External validation of the PAANTHER TB treatment decision algorithm.

What condition does NCT04121026 study?

NCT04121026 studies Tuberculosis, HIV.

Is NCT04121026 still recruiting?

NCT04121026 is currently completed. Last updated 28 March 2025.

Last reviewed 2025-03-28 · How we verify

NCT04121026

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

Validation of a Tuberculosis Treatment Decision Algorithm in HIV-infected Children (TB-Speed HIV)

Completed NA Last updated 28 March 2025

What this trial tests

NA trial testing External validation of the PAANTHER TB treatment decision algorithm in Tuberculosis in 278 participants. Completed in 20 June 2022.

Timeline

2 October 2019

Primary endpoint
20 June 2022

20 June 2022

Quick facts

Lead sponsor	Institut National de la Santé Et de la Recherche Médicale, France
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	278
Start date	2 October 2019
Primary completion	20 June 2022
Estimated completion	20 June 2022
Sites	7 locations across Zambia, Mozambique, Côte d’Ivoire, Uganda

Drugs / interventions tested

External validation of the PAANTHER TB treatment decision algorithm

Conditions studied

Tuberculosis — all drugs for Tuberculosis →
HIV — all drugs for HIV →

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France — full company profile →

Who can join

Adults 1 Month to 14, any sex, with Tuberculosis or HIV. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

TB-Speed HIV is a prospective multicentre management study evaluating the safety and feasibility of the recently proposed PAANTHER TB treatment decision algorithm for HIV-infected children with presumptive TB. It will be conducted in four countries with high and very high TB (Tuberculosis) incidence (Côte d'Ivoire, Uganda, Mozambique, and Zambia) which have not participated in the study that developed the PAANTHER algorithm.

Publications & conference data

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

Xpert MTB/RIF Ultra assay for tuberculosis disease and rifampicin resistance in children.
Kay AW, Ness T, Verkuijl SE, Viney K, et al · · 2022 · cited 53× · PMID 36065889 · DOI 10.1002/14651858.cd013359.pub3
The diagnostic yield of nasopharyngeal aspirate for pediatric pulmonary tuberculosis: a systematic review and meta-analysis.
Khambati N, Song R, MacLean EL, Kohli M, et al · · 2023 · cited 2× · PMID 38628460 · DOI 10.1186/s44263-023-00018-1

Verify or expand the search:

Other recruiting trials for Tuberculosis

Currently open trials in the same condition.

NCT05917210 — Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda · NA · recruiting
NCT07170735 — Quantitative Measurement of Plasma and Urine MTB Cell-free DNA Level · recruiting
NCT07484490 — Effects of the Active Cycle of Breathing Technique With and Without Balloon Blowing Therapy in Tuberculosis · NA · recruiting
NCT06318416 — Precision Rifampin Trial for Personalized Dosing · Phase 1 · recruiting
NCT07170800 — A Phase 2b Clinical Study of JDB0131 Benzenesulfonate Tablets · Phase 2 · recruiting

Other Institut National de la Santé Et de la Recherche Médicale, France trials

Trials by the same sponsor.

NCT07311213 — GENES AND AUTISM - IPSC · NA · not yet recruiting
NCT07063719 — Identification of Cellular Biomarkers of Rare Eye Diseases in Adults · NA · not yet recruiting
NCT06906042 — Multimodal Cardiovascular and Hepatic Population Imaging · recruiting
NCT06951035 — Impact of rTMS on BCI Control in Upper Limb Motor Rehabilitation of Patients With Chronic Stroke · NA · not yet recruiting
NCT06660108 — MOLECULAR BASIS OF LANGUAGE DEVELOPMENT AND ASSOCIATED DISORDERS · NA · 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 NCT04121026 (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 Institut National de la Santé Et de la Recherche Médicale, France
Last refreshed: 28 March 2025

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/NCT04121026.

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