CompletedNot Applicable

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

Switzerland206 participantsStarted 2015-11

Plain-language summary

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.

Who can participate

Age range1 Day – 3 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Diagnostic accuracy compared to expert panel for bacterial versus viral.

Timeframe: 0-7 days after initiation of symptoms

Trial details

NCT IDNCT03224026

SponsorMeMed Diagnostics Ltd.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2018-06

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