Status:

WITHDRAWN

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

Lead Sponsor:

Foundation for Innovative New Diagnostics, Switzerland

Collaborating Sponsors:

Makerere University

Ministry of Public Health, Democratic Republic of the Congo

Conditions:

Human African Trypanosomiasis

Eligibility:

All Genders

6+ years

Brief 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 develo...

Eligibility Criteria

Inclusion

  • Age greater than or equal to 6 years
  • Provision of signed informed consent. For children (under the age of 18) provision of signed informed consent by a parent or legal guardian and an age appropriate assent.

Exclusion

  • Severe anaemia preventing collection of a sample of venous blood
  • Severe medical condition preventing informed consent and trial participation (e.g. coma, cognitive impairment, etc.)
  • For HAT true negatives only: history of previous HAT infection

Key Trial Info

Start Date :

January 31 2022

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 31 2022

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT03394976

Start Date

January 31 2022

End Date

December 31 2022

Last Update

January 9 2024

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