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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Fever Respiratory Tract Infections Urinary Tract Infections Gastroenteritis Arthritis, Infectious

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No