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

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ClinicalTrials.gov Identifier: NCT03224026
Recruitment Status : Completed
First Posted : July 21, 2017
Last Update Posted : August 15, 2018
Sponsor:
Collaborator:
University Hospital, Geneva
Information provided by (Responsible Party):
MeMed Diagnostics Ltd.

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.

Condition or disease
Infectious Disease Fever Viremia

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Study Type : Observational
Actual Enrollment : 206 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Which Virus Leads to Viremia in Children With Fever Without Source and do New Biomarkers Correlate With Viral and Bacterial Infections?
Actual Study Start Date : November 2015
Actual Primary Completion Date : June 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Fever Without Source
Clinical diagnosis of FWS (fever of less than 7 days with no cause determined by the history and the physical exam).
Healthy control
Children visiting the hospital due to a non-infectious, non inflammatory etiology



Primary Outcome Measures :
  1. Diagnostic performance of a proteomic signature for discriminating between viral and bacterial infections in children aged three months to three years presenting with fever without source [ Time Frame: 0-7 days after the initiation of symptoms ]
    Sensitivity, Specificity, Positive predictive value and negative predictive value of the test for discriminating viral from bacterial infection in the study cohort


Secondary Outcome Measures :
  1. Diagnostic performance of a proteomic signature for discriminating between viral and bacterial infections in children under three months of age [ Time Frame: 0-7 days after the initiation of symptoms ]
    Sensitivity, Specificity, Positive predictive value and negative predictive value of the test for discriminating viral from bacterial infection in the study cohort

  2. Prevalence of Human Enteroviruses, Human Parechoviruses, Adenovirus and Human Herpesvirus type 6 viremia, as well as K. kingae bacteremia in children under three years old presenting with fever without source [ Time Frame: 0-7 days after the initiation of symptoms ]

Biospecimen Retention:   Samples Without DNA
Serum, Plasma, whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03224026


Locations
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Switzerland
Geneva University Hospitals
Geneva, Switzerland
Sponsors and Collaborators
MeMed Diagnostics Ltd.
University Hospital, Geneva
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: MeMed Diagnostics Ltd.
ClinicalTrials.gov Identifier: NCT03224026    
Other Study ID Numbers: MM-15082-Vir
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Communicable Diseases
Infection
Viremia
Fever
Body Temperature Changes
Virus Diseases
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes