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

NCT03394976 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2024-01-09

No results posted yet for this study

Summary

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.

Conditions

  • Human African Trypanosomiasis

Interventions

DIAGNOSTIC_TEST

No intervention

No intervention

Sponsors & Collaborators

  • Makerere University

    collaborator OTHER

  • Ministry of Public Health, Democratic Republic of the Congo

    collaborator OTHER_GOV

  • Foundation for Innovative New Diagnostics, Switzerland

    lead OTHER

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-31
Primary Completion
2022-12-31
Completion
2022-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03394976 on ClinicalTrials.gov