Clinical trial NCT01911143: A Retrospective, Blinded Validation of a Host-response Based Diagnostics
Official title: A Retrospective, Blinded Validation Study to Assess the Accuracy of a Host-response Based Diagnostics for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients With an Acute Febrile Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fever
Respiratory Tract Infections
Urinary Tract Infections
Gastroenteritis
Arthritis, Infectious
Lead sponsor: MeMed Diagnostics Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Bnai Zion Medical Center
name: University Hospital, Geneva
First posted: 2013-07-30
Enrollment: 600
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will include patients aged 1 month to 18 years of age that were sampled both during emergency department (ED) visit or during hospitalization stay and were diagnosed with an acute infectious disease or a non-infectious disease. All samples are expected to fall 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 a non-infectious disease (control group)

Brief summary: This is a retrospective, blinded, external validation study of a novel in-vitro diagnostic (IVD) assay that will include samples that were previously collected from febrile pediatric patients. The investigated assay measures the levels of a few host-related, blood-based, bio-markers that will be integrated into a single score. Based on this score, each patient will be classified into one of three categories: (i) bacterial immune response, (ii) viral immune response, and (iii) marginal immune response. The assay prediction and the patient diagnosis will than be unveiled and compared to determine their level of concordance.


Eligibility criteria: Inclusion Criteria:

The infectious disease samples should also fulfill the following criteria:

* The patient had a peak temperature ≥38°C (AND)
* Symptoms initiated ≤ 7 days before sampling

The non-infectious disease control group will include:

* Patients with a non-infectious disease

Exclusion Criteria:

* Another infection episode during the last 3 weeks before sampling
* Congenital immune deficiency (CID)
* A proven or suspected HIV-1, HBV, HCV infection
* Active hematological malignancy
* Current treatment with immune-suppressive or immune-modulating
* Other illnesses that affect life expectancy and/or quality of life

Primary outcomes:
measure: The sensitivity and specificity of the assay in differentiating between bacterial and viral etiology of patients with an acute febrile disease
timeFrame: 0-7 days after the initiation of symptoms
Secondary outcomes:
measure: The sensitivity and specificity of the assay in differentiating between infectious and non-infectious disease etiology.
timeFrame: 0-7 days after the initiation of symptoms
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
Study officials:
affiliation: MeMed Diagnostics Ltd.
name: Kfir Oved, Dr.
role: STUDY_DIRECTOR
References: