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Completed

NCT Number: NCT03224026

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

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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Key information

Conditions

Infectious Disease Body Temperature Changes Communicable Diseases Disease Attributes Fever Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Signs and Symptoms Systemic Inflammatory Response Syndrome Viremia Virus Diseases

Age range

1 day–3 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Geneva University Hospitals

Geneva, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Diagnostic accuracy compared to expert panel for bacterial versus viral.

    Time frame: 0-7 days after initiation of symptoms

    Sensitivity, specificity, NPV and PPV were measured for ImmunoXpert and Labscore.

    The proteomic signature is a combination of different markers including: tumor necrosis factor-related apoptosis-inducing ligand (TRAIL) (pg/mL), interferon γ-induced protein-10 (IP-10) (pg/mL) and C-reactive protein (CRP) (mg/L). The proteomic signature is expressed as a score (no units. ranges 0-100).

    The Labscore is a combination of procalcitonin (ng/mL), C-reactive protein (CRP) (mg/L) and urinary dipstix (positive if presence of leucocyturia or nitrites). The Lab-score is expressed as a score (no units. ranges 0-9)

Secondary outcomes

  1. Diagnostic accuracy compared to microbiology gold standard for ruling out invasive bacterial infection.

    Time frame: 0-7 days after initiation of symptoms

    Case by case comparison between microbiology gold standard and ImmunoXpert and Labscore.

    The proteomic signature is a combination of different markers including: tumor necrosis factor-related apoptosis-inducing ligand (TRAIL) (pg/mL), interferon γ-induced protein-10 (IP-10) (pg/mL) and C-reactive protein (CRP) (mg/L). The proteomic signature is expressed as a score (no units, ranges 0-100).

    The Labscore is a combination of procalcitonin (ng/mL), C-reactive protein (CRP) (mg/L) and urinary dipstix (positive if presence of leucocyturia or nitrites). The Lab-score is expressed as a score (no units, ranges 0-9).

  2. Comparison of biomarker levels in patients with different etiologies as classified by the expert panel or healthy.

    Time frame: 0-7 days after initiation of symptoms in cases with infection.

    An expert panel classified a patient as experiencing a bacterial versus viral infection. In addition healthy patients were requited.

    The following biomarkers were examined across the healthy versus bacterial versus viral patients:

    • The proteomic signature is a combination of different markers including: tumor necrosis factor-related apoptosis-inducing ligand (TRAIL) (pg/mL), interferon γ-induced protein-10 (IP-10) (pg/mL) and C-reactive protein (CRP) (mg/L). The proteomic signature is expressed as a score (no units, ranges 0-100).
    • The Labscore is a combination of procalcitonin (ng/mL), C-reactive protein (CRP) (mg/L) and urinary dipstix (positive if presence of leucocyturia or nitrites). The Lab-score is expressed as a score (no units, ranges 0-9).
    • Tumor necrosis factor-related apoptosis-inducing ligand (TRAIL) (pg/mL).
    • interferon γ-induced protein-10 (IP-10) (pg/mL).
    • C-reactive protein (CRP) (mg/L).

  3. Prevalence of viruses in children with fever without source.

    Time frame: 0-7 days after the initiation of symptoms

    Prevalence of Human Enteroviruses, Human Parechoviruses, Adenovirus and Human Herpesvirus type 6 viremia and viremia from other microorganism identified by Next-Generation Sequencing (NGS) (no units) or other techniques, as well as K. kingae bacteremia in children under three years old presenting with fever without source.

Sponsors and collaborators

Lead sponsor

MeMed Diagnostics Ltd.

Industry

Collaborators

  • University Hospital, Geneva

Registry information

Official study title

Which Virus Leads to Viremia in Children With Fever Without Source and do New Biomarkers Correlate With Viral and Bacterial Infections?

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jul 21, 2017
Registry last updated
Jan 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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