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NCT03394976
Prospective Evaluation of an RDT to Screen for Gambiense HAT and Diagnose P. Falciparum Malaria
trial testing No intervention in Human African Trypanosomiasis. Withdrawn.
31 December 2022
Quick facts
| Lead sponsor | Foundation for Innovative New Diagnostics, Switzerland |
|---|---|
| Status | Withdrawn |
| Study type | OBSERVATIONAL |
| Start date | 31 January 2022 |
| Primary completion | 31 December 2022 |
| Estimated completion | 31 December 2022 |
Drugs / interventions tested
- No intervention
Conditions studied
- Human African Trypanosomiasis — all drugs for Human African Trypanosomiasis →
Sponsor
Foundation for Innovative New Diagnostics, Switzerland
Who can join
6 and older, any sex, with Human African Trypanosomiasis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A prototype rapid diagnostic test (RDT) to simultaneously screen for gambiense human African trypanosomiasis (HAT) and diagnose P. falciparum malaria (the "HAT/malaria combo") has recently been developed. The performance of this prototype has been evaluated in a retrospective study that showed that its diagnostic performance for HAT and malaria was equivalent to the performance of the SD BIOLINE HAT 2.0 and the SD BIOLINE Malaria Ag P.f tests, respectively. The purpose of this study is to prospectively evaluate the performance of the test in settings where P. falciparum malaria is endemic, and which are either endemic or non-endemic for HAT. This will enable the assessment of the suitability of the HAT/malaria combo RDT as a diagnostic test for malaria, and a screening test for HAT in pre-elimination and post-elimination contexts, respectively.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03394976
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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 NCT03394976 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Foundation for Innovative New Diagnostics, Switzerland
- Last refreshed: 9 January 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/NCT03394976.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing