Diagnostic Accuracy of a Host-response Based Diagnostic Tool for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 18 October 2021
• Main ID: NCT03052088
• Date of registration: 10/02/2017
• Prospective Registration: No
• Primary sponsor: MeMed Diagnostics Ltd.
• Public title: Diagnostic Accuracy of a Host-response Based Diagnostic Tool for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients AutoPilot
• Scientific title: A Multi-center, Prospective, Pilot Study to Validate the Diagnostic Accuracy and Assess the Potential Clinical Utility of a Host-response Based Diagnostic Tool for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients Presenting to the Emergency Department With Respiratory Tract Infection (RTI) or Fever Without Source (FWS)
• Date of first enrolment: February 6, 2017
• Target sample size: 1140
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03052088
• Study type: Observational

Countries of recruitment

Germany, Italy

Contacts

• Name: Tobias Tenenbaum, MD
• Affiliation: Kinderklinik Universitatsmedizine mannheim

Key inclusion & exclusion criteria

Inclusion Criteria:

- Legal guardian signs an informed consent

- Documented peak temperature = 38°C (100.4°F)

- Symptom duration = 7 days

- Clinical suspicion of RTI (OR) fever without a clear source after clinical examination

Exclusion Criteria:

- Another episode of febrile infection within the past 2 weeks

- Antibiotic treatment of over 48 hours

- Congenital immune deficiency (CID)

- A proven or suspected HIV, HBV, HCV infection

- 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/or quality of life such as:

- Severe psychomotor retardation

- Post-transplant patients

- Severe congential metabolic disorder



Age minimum: 3 Months
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Respiratory Tract Infections

Fever

Primary Outcome(s)

To validate the diagnostic accuracy and assess the clinical utility of a host-response based diagnostic tool, for differentiating between bacterial and viral etiologies in pediatric patients >90 days old with suspicion of RTI or FWS [Time Frame: 0-7 days after the initiation of symptoms]

Secondary Outcome(s)

To compare ImmunoXpert™ results with the physician suspected diagnosis at time of patient recruitment and compared to the reference standard diagnosis [Time Frame: 0-7 days after the initiation of symptoms]

To compare the diagnostic accuracy of a host-response based diagnostic to currently available lab measures (WBC, ANC, CRP and PCT), using sensitivity and specificity measures and predetermined cutoffs [Time Frame: 0-7 days after the initiation of symptoms]

Secondary ID(s)

MM-1006-AP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

European Commission

Heidelberg University

University of Parma