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

MeMed

Status: Completed

Conditions: Fever; Viremia; Infectious Disease

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03224026

MM-15082-Vir

Details and patient eligibility

About

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.

Enrollment: 206 patients

Sex: All

Ages: 1 day to 3 years old

Volunteers: Accepts Healthy Volunteers

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

Exclusion criteria

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

Inclusion Criteria for healthy controls:

• 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.

Trial design

206 participants in 2 patient groups

Fever Without Source

Description:

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

Healthy control

Description:

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