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A Controlled, Blinded Study to Validate the Diagnostic Accuracy and Assess the Clinical Utility of a Host-response Based Diagnostic Tool for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients Presenting to the ED With Suspicion of Acute Infection (ROSETTA)

M

MeMed

Status

Unknown

Conditions

Antibiotic Misuse
Viral Infection
Host Response Diagnostics
Bacterial Infections

Treatments

Diagnostic Test: ImmunoXpert™

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT04254991
0666-15-RMC

Details and patient eligibility

About

To externally validate the diagnostic accuracy and assess the clinical utility of a host-response based diagnostic tool called ImmunoXpert™, for differentiating between bacterial and viral etiologies in pediatric patients >3 months old with suspicion of Respiratory tract infection (RTI) or Fever without Source (FWS)

Enrollment

525 patients

Sex

All

Ages

3 months to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Documented peak temperature ≥ 38°C (100.4°F) (AND)
  • Symptom duration ≤ 7 days (AND)
  • Clinical suspicion of RTI (OR)
  • Fever without a clear source (OR)
  • Acute gastroenteritis (OR)
  • Urinary tract infection

Exclusion criteria

  • Antibiotic treatment of over 48 hours' duration at time of presentation

  • Another episode of febrile infection within the past 2 weeks

  • A proven or suspected HIV1, HBV, or HCV infection

  • Congenital immune deficiency (CID)

  • Active malignancy

  • Current treatment with immune-suppressive or immune-modulating therapies, including without limitations:

    • Use of high dose steroids >1 mg/kg/day prednisone or equivalent in the past two weeks Monoclonal antibodies, anti-TNF agents
    • Intravenous immunoglobulin (IVIG)
    • Cyclosporine, Cyclophosphamide, Tacrolimus
    • G/GM-CSF, Interferons
  • Other severe illnesses that affect life expectancy and quality of life such as:

    • Moderate to severe psychomotor retardation
    • Post-transplant patients
    • Moderate to severe congenital metabolic disorder

Trial design

525 participants in 2 patient groups

Infectious disease group
Treatment:
Diagnostic Test: ImmunoXpert™
Non-infectious disease group
Treatment:
Diagnostic Test: ImmunoXpert™

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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