Trials / Withdrawn
WithdrawnNCT03394976
Prospective Evaluation of an RDT to Screen for Gambiense HAT and Diagnose P. Falciparum Malaria
Prospective Evaluation of a Rapid Diagnostic Test to Screen for Gambiense Human African Trypanosomiasis and Diagnose Plasmodium Falciparum Malaria
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland · Academic / Other
- Sex
- All
- Age
- 6 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | No intervention | No intervention |
Timeline
- Start date
- 2022-01-31
- Primary completion
- 2022-12-31
- Completion
- 2022-12-31
- First posted
- 2018-01-09
- Last updated
- 2024-01-09
Source: ClinicalTrials.gov record NCT03394976. Inclusion in this directory is not an endorsement.