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NCT03394976

Prospective Evaluation of an RDT to Screen for Gambiense HAT and Diagnose P. Falciparum Malaria

Withdrawn Last updated 9 January 2024
What this trial tests

trial testing No intervention in Human African Trypanosomiasis. Withdrawn.

Timeline
31 January 2022
Primary endpoint
31 December 2022
31 December 2022

Quick facts

Lead sponsorFoundation for Innovative New Diagnostics, Switzerland
StatusWithdrawn
Study typeOBSERVATIONAL
Start date31 January 2022
Primary completion31 December 2022
Estimated completion31 December 2022

Drugs / interventions tested

Conditions studied

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.

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Other trials of No intervention

Trials testing the same drug.

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Data sources for this page

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.

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