Clinical trial NCT03224026: Validation of a Proteomic Signature and Assessment of Viremia in Children With Fever Without Source
Official title: Which Virus Leads to Viremia in Children With Fever Without Source and do New Biomarkers Correlate With Viral and Bacterial Infections?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infectious Disease
Fever
Viremia
Lead sponsor: MeMed Diagnostics Ltd.
Sponsor class: INDUSTRY
Collaborators: name: University Hospital, Geneva
First posted: 2017-07-21
Enrollment: 206
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients below three years old which were presented with a diagnosis of fever without source to the emergency room in the Children's Hospital, Geneva University Hospitals

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic accuracy compared to expert panel for bacterial versus viral.
timeFrame: 0-7 days after initiation of symptoms
Secondary outcomes:
measure: Diagnostic accuracy compared to microbiology gold standard for ruling out invasive bacterial infection.
timeFrame: 0-7 days after initiation of symptoms
measure: Comparison of biomarker levels in patients with different etiologies as classified by the expert panel or healthy.
timeFrame: 0-7 days after initiation of symptoms in cases with infection.
measure: Prevalence of viruses in children with fever without source.
timeFrame: 0-7 days after the initiation of symptoms
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
Study officials:
References:
citation: Oved K, Cohen A, Boico O, Navon R, Friedman T, Etshtein L, Kriger O, Bamberger E, Fonar Y, Yacobov R, Wolchinsky R, Denkberg G, Dotan Y, Hochberg A, Reiter Y, Grupper M, Srugo I, Feigin P, Gorfine M, Chistyakov I, Dagan R, Klein A, Potasman I, Eden E. A novel host-proteome signature for distinguishing between acute bacterial and viral infections. PLoS One. 2015 Mar 18;10(3):e0120012. doi: 10.1371/journal.pone.0120012. eCollection 2015.
citation: Colvin JM, Muenzer JT, Jaffe DM, Smason A, Deych E, Shannon WD, Arens MQ, Buller RS, Lee WM, Weinstock EJ, Weinstock GM, Storch GA. Detection of viruses in young children with fever without an apparent source. Pediatrics. 2012 Dec;130(6):e1455-62. doi: 10.1542/peds.2012-1391. Epub 2012 Nov 5.
citation: Ambrosioni J, Bridevaux PO, Wagner G, Mamin A, Kaiser L. Epidemiology of viral respiratory infections in a tertiary care centre in the era of molecular diagnosis, Geneva, Switzerland, 2011-2012. Clin Microbiol Infect. 2014 Sep;20(9):O578-84. doi: 10.1111/1469-0691.12525. Epub 2014 Jan 24.
citation: L'Huillier AG, Mardegan C, Cordey S, Luterbacher F, Papis S, Hugon F, Kaiser L, Gervaix A, Posfay-Barbe K, Galetto-Lacour A. Enterovirus, parechovirus, adenovirus and herpes virus type 6 viraemia in fever without source. Arch Dis Child. 2020 Feb;105(2):180-186. doi: 10.1136/archdischild-2019-317382. Epub 2019 Aug 28.