Validation of a Proteomic Signature and Assessment of Viremia in Children With Fever Without Source

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

206 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2018-08-31

Brief Summary

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The study is an observational blinded Validation study in pediatric patients below 3 years old with a diagnosis of Fever Without Source (FWS). In this study the investigators aim to validate the performance of a proteomic signature aiding the physicians to discriminate between viral and bacterial infections in febrile children. The study will also assess the prevalence of Human Enteroviruses (HEV), Human Parechoviruses (HPeV), Adenovirus (AdV) and Human Herpesvirus type 6 (HHV-6) viremia, as well as Kingella Kingae bacteremia in the study cohort.

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Detailed Description

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Conditions

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Infectious Disease Fever Viremia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Fever Without Source

Clinical diagnosis of FWS (fever of less than 7 days with no cause determined by the history and the physical exam).

No interventions assigned to this group

Healthy control

Children visiting the hospital due to a non-infectious, non inflammatory etiology

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of FWS (fever of less than 7 days with no cause determined by the history or the physical exam)
* Age \< 3 years old
* Informed consent (IC) given by parent or legal guardian

* Age \< 3 years old
* Informed consent (IC) given by parent or legal guardian
* No suspicion of infectious or inflammatory disease at presentation and during the two weeks before.

Exclusion Criteria

* Unavailable blood
* Comorbidities predisposing to infections such as cancer, primary or secondary immunodeficiency, and iatrogenic immunosuppression

Minimum Eligible Age

1 Day

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes