Trials / Completed
CompletedNCT01911143
A Retrospective, Blinded Validation of a Host-response Based Diagnostics
A Retrospective, Blinded Validation Study to Assess the Accuracy of a Host-response Based Diagnostics for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients With an Acute Febrile Disease
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 600 (actual)
- Sponsor
- MeMed Diagnostics Ltd. · Industry
- Sex
- All
- Age
- 1 Month – 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a retrospective, blinded, external validation study of a novel in-vitro diagnostic (IVD) assay that will include samples that were previously collected from febrile pediatric patients. The investigated assay measures the levels of a few host-related, blood-based, bio-markers that will be integrated into a single score. Based on this score, each patient will be classified into one of three categories: (i) bacterial immune response, (ii) viral immune response, and (iii) marginal immune response. The assay prediction and the patient diagnosis will than be unveiled and compared to determine their level of concordance.
Conditions
Timeline
- Start date
- 2013-09-01
- Primary completion
- 2015-08-01
- Completion
- 2015-08-01
- First posted
- 2013-07-30
- Last updated
- 2016-03-08
Locations
2 sites across 1 country: Israel
Source: ClinicalTrials.gov record NCT01911143. Inclusion in this directory is not an endorsement.