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

Human African Trypanosomiasis Clinical Trial

Official title:

Prospective Evaluation of a Rapid Diagnostic Test to Screen for Gambiense Human African Trypanosomiasis and Diagnose Plasmodium Falciparum Malaria

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03394976
• Other study ID #: HAT-malaria RDT evaluation
• Status: Withdrawn
• Start date: January 31, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2024
• Source: Foundation for Innovative New Diagnostics, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Human African Trypanosomiasis
• Malaria
• Malaria, Falciparum
• Trypanosomiasis
• Trypanosomiasis, African

Intervention

Diagnostic Test:
• No intervention
No intervention

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Foundation for Innovative New Diagnostics, Switzerland	Makerere University, Ministry of Public Health, Democratic Republic of the Congo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	specificity of the HAT/malaria combo test for gambiense HAT in passive screening		Enrolment
Primary	specificity of the SD BIOLINE HAT 2.0 test for gambiense HAT in passive screening		Enrolment
Primary	sensitivity of the HAT/malaria combo test for P. falciparum malaria in passive screening		Enrolment
Primary	sensitivity of the SD BIOLINE Malaria Ag P.f test for P. falciparum malaria in passive screening		Enrolment
Primary	specificity of the HAT/malaria combo test for P. falciparum malaria in passive screening		Enrolment
Primary	specificity of the SD BIOLINE Malaria Ag P.f test for P. falciparum malaria in passive screening		Enrolment
Secondary	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
Secondary	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
Secondary	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
Secondary	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