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

Withdrawn

• Conditions: Human African Trypanosomiasis
• Interventions: Diagnostic Test: No intervention

• Registration Number: NCT03394976
• Lead Sponsor: Foundation for Innovative New Diagnostics, Switzerland

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-11
• Study First Submitted QC: 2018-01-03
• Study First Posted: 2018-01-09
• Study Start: 2022-01-31
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-05
• Last Update Posted: 2024-01-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study population	No intervention	Participants will be enrolled passively at health centres. Passive enrolment will include patients referred to or presenting directly at the health facilities.

Primary Outcome Measures

Name	Time	Method
sensitivity of the HAT/malaria combo test for P. falciparum malaria in passive screening	Enrolment
specificity of the HAT/malaria combo test for P. falciparum malaria in passive screening	Enrolment
specificity of the SD BIOLINE Malaria Ag P.f test for P. falciparum malaria in passive screening	Enrolment
specificity of the HAT/malaria combo test for gambiense HAT in passive screening	Enrolment
specificity of the SD BIOLINE HAT 2.0 test for gambiense HAT in passive screening	Enrolment
sensitivity of the SD BIOLINE Malaria Ag P.f test for P. falciparum malaria in passive screening	Enrolment

Secondary Outcome Measures

Name	Time	Method
specificity of the HAT/malaria combo test for gambiense HAT in passive screening in a population living in a setting where HAT and animal trypanosomiasis are not endemic	Enrolment
specificity of the HAT/malaria combo test for gambiense HAT in passive screening in a population living in a setting where HAT is endemic	Enrolment
specificity of the SD BIOLINE HAT 2.0 test for gambiense HAT in passive screening in a population living in a setting where HAT and animal trypanosomiasis are not endemic	Enrolment
specificity of the SD BIOLINE HAT 2.0 test for gambiense HAT in passive screening in a population living in a setting where HAT is endemic	Enrolment