Trials / Completed
CompletedNCT03047642
Validation of Promising Biomarker Assays to Assess Their Diagnostic Performance Characteristics
Validation of Promising Biomarker Assays to Assess Their Diagnostic Performance Characteristics in Africa and Latin America
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,000 (actual)
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland · Academic / Other
- Sex
- All
- Age
- 2 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This project aims to evaluate the performance characteristics of rapid tests to differentiate bacterial from non-bacterial infection in febrile adults and children presenting at OPDs (outpatient departments) i.e.("fever triage assays") in three LMICs. The evaluation will include a different commercial biomarker combinations as well as individual biomarkers to assess their individual or combined value in the target population. Markers will be evaluated onsite in ELISA or RDT format, as appropriate. Further, this study aims to contribute to a centralized biobank of well-characterized specimens for use by IVD companies and academic institutions for the development and evaluation of emerging assays.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Biomarker assay | There is no intervention on the patients but biomarker assays are being evaluated for their performance to distinguish bacterial infection from non-bacterial infections in febrile patients |
Timeline
- Start date
- 2017-04-27
- Primary completion
- 2018-10-27
- Completion
- 2019-11-27
- First posted
- 2017-02-09
- Last updated
- 2021-02-16
Locations
3 sites across 3 countries: Brazil, Gabon, Malawi
Source: ClinicalTrials.gov record NCT03047642. Inclusion in this directory is not an endorsement.