Clinical trial NCT04254991: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Viral Infection
Bacterial Infections
Antibiotic Misuse
Host Response Diagnostics
Lead sponsor: MeMed Diagnostics Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Schneider Children's Medical Center, Israel
First posted: 2020-02-05
Enrollment: 525
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include eligible subjects from both genders that present to the ED due to suspected RTI, FWS, GE, UTI or non-febrile non-infectious disease (Control). Each of these subjects falls into one of the following categories:

1. Patients with an acute bacterial infection
2. Patients with an acute viral infection
3. Patients with an acute mixed co-infection (bacterial and viral)
4. Patients with an undetermined disease etiology
5. Patients with a non-infectious disease (control group)

Brief summary: 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)


Eligibility criteria: 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

Primary outcomes:
measure: ImmunoXpert™ Diagnostic Performance
timeFrame: Through study completion, an average of 3 years
Secondary outcomes:
measure: ImmunoXpert™ Diagnostic Performance in Pediatric Patients with Gastroenteritis
timeFrame: Through study completion, an average of 3 years
measure: ImmunoXpert™ Diagnostic Performance in Pediatric Patients with Urinary Tract Infection
timeFrame: Through study completion, an average of 3 years
Other outcomes:
Locations:
Study officials:
References: