A Retrospective, Blinded Validation of a Host-response Based Diagnostics (PATHFINDER)

MeMed

Status: Completed

Conditions: Fever; Urinary Tract Infections; Gastroenteritis; Arthritis, Infectious; Respiratory Tract Infections

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01911143

MM-1002-BV

Details and patient eligibility

About

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.

Enrollment: 600 patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

The infectious disease samples should also fulfill the following criteria:

• The patient had a peak temperature ≥38°C (AND)
• Symptoms initiated ≤ 7 days before sampling

The non-infectious disease control group will include:

• Patients with a non-infectious disease

Exclusion criteria

• Another infection episode during the last 3 weeks before sampling
• Congenital immune deficiency (CID)
• A proven or suspected HIV-1, HBV, HCV infection
• Active hematological malignancy
• Current treatment with immune-suppressive or immune-modulating
• Other illnesses that affect life expectancy and/or quality of life