Last reviewed · How we verify
NCT05047315: Stool4TB
Evaluating a New Stool Based qPCR for Diagnosis of Tuberculosis in Children and People Living With HIV
trial in Tuberculosis in 1,967 participants. Completed in 30 June 2025.
17 December 2024
Quick facts
| Lead sponsor | Barcelona Institute for Global Health |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,967 |
| Start date | 1 December 2021 |
| Primary completion | 17 December 2024 |
| Estimated completion | 30 June 2025 |
| Sites | 3 locations across Mozambique, Eswatini, Uganda |
Conditions studied
- Tuberculosis — all drugs for Tuberculosis →
- Diagnoses Disease — all drugs for Diagnoses Disease →
Sponsor
Barcelona Institute for Global Health
Who can join
Adults 0 to 8, any sex, with Tuberculosis or Diagnoses Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Stool4TB aims to evaluate an innovative stool-based qPCR diagnostic platform (with the capacity to become a POC diagnostic tool) in the high TB and HIV burden settings of Mozambique, Eswatini and Uganda, under the hypothesis that it will narrow the extremely large TB case detection gap by improving TB confirmation rates in children and people living with HIV (PLHIV).
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
A stool based qPCR for the diagnosis of TB in children and people living with HIV in Uganda, Eswatini and Mozambique (Stool4TB): a protocol for a multicenter diagnostic evaluation.
Carratala-Castro L, Ssengooba W, Kay A, Acácio S, et al · · 2024 · cited 9× · PMID 38383310 · DOI 10.1186/s12879-023-08708-9 -
Performance of stool Xpert MTB/RIF Ultra for detection of Mycobacterium tuberculosis among adults living with HIV: a multicentre, prospective diagnostic study.
Kasule GW, Hermans S, Acacio S, Kay A, et al · · 2025 · cited 5× · PMID 40194533 · DOI 10.1016/j.lanmic.2025.101085 -
Perceived Feasibility of stool-based Tuberculosis diagnostics in children and adults with HIV in Uganda and Eswatini: Healthcare workers’ perspectives
Kikoyo JN, Nkala B, Shabalala F, Dlamini FD, et al · · 2026 · DOI 10.21203/rs.3.rs-9609814/v1 -
Stool based qPCR for the diagnosis of TB in children and people living with HIV in Uganda, Eswatini and Mozambique (Stoo4TB): a protocol for a multicenter diagnostic evaluation
Carratala-Castro L, Ssengooba W, Kay A, Acacio S, et al · · 2023 · DOI 10.21203/rs.3.rs-3398598/v1
Verify or expand the search:
- PubMed search for NCT05047315
- 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 NCT05047315 (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 Barcelona Institute for Global Health
- Last refreshed: 6 March 2026
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/NCT05047315.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing