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

Sponsor

Foundation for Innovative New Diagnostics, Switzerland (Other)

Overall Status

Unknown status

CT.gov ID

NCT03394976

Collaborator

Makerere University (Other), Ministry of Public Health, Democratic Republic of the Congo (Other)

2,500

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Human African Trypanosomiasis	Diagnostic Test: No intervention

Study Design

Study Type:

Observational

Anticipated Enrollment :

2500 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2020

Anticipated Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Study population Participants will be enrolled passively at health centres. Passive enrolment will include patients referred to or presenting directly at the health facilities.	Diagnostic Test: No intervention No intervention

Arm

Intervention/Treatment

Study population

Participants will be enrolled passively at health centres. Passive enrolment will include patients referred to or presenting directly at the health facilities.

Diagnostic Test: No intervention

No intervention

Outcome Measures

Primary Outcome Measures

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 HAT/malaria combo test for P. falciparum malaria in passive screening [Enrolment]
sensitivity 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 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]

Secondary Outcome Measures

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 is endemic [Enrolment]
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 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Foundation for Innovative New Diagnostics, Switzerland

ClinicalTrials.gov Identifier:

NCT03394976

Other Study ID Numbers:

HAT-malaria RDT evaluation

First Posted:

Jan 9, 2018

Last Update Posted:

Feb 15, 2019

Last Verified:

Feb 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Malaria

Malaria, Falciparum

Trypanosomiasis

Trypanosomiasis, African

Study Results

No Results Posted as of Feb 15, 2019