A multi-center, prospective, blinded validation study to assess the accuracy of a host-response based diagnostics for distinguishing between bacterIal and viral etiology in pediatric patients with lower respiratory tract infections and fever without source

Completed

• Conditions: Lower Respiratory Tract infection (LRTI); 10047438; 10024970

• Registration Number: NL-OMON40268
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 250

Inclusion Criteria

Patients aged 1 to 60 months whose legal guardian agrees to sign an informed consent will be eligible for inclusion. ;The infectious disease group should also fulfill the following criteria:
* Peak fever >=38°C (100.4°F) (AND)
* Symptoms duration <= 6days (AND)
* Clinical suspicion of LRTI (OR)
* Fever without a clear source;The non-infectious disease control group will include:
* Patients with clinical suspicion of a non-infectious disease

Exclusion Criteria

- Another episode of an acute infection during the last 3 weeks
- Congenital immune deficiency (CID)
- A proven or suspected human immunodeficiency virus (HIV)-1, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection
- Active malignancy
- Current treatment with immune-suppressive or immune-modulating therapies including without limitations:
a) High dose steroids >1 mg/kg/day prednisone or equivalent
b) Monoclonal antibody administration
c) Intravenous immunoglobulin (IVIG)
d) Cyclosporine
e) G/GM-CSF
f) Anti-TNF agents
g) Interferon (of all kinds)
-Other severe illnesses that affect life expectancy and quality of life such as:
a) Moderate to severe psychomotor retardation
b) Moderate to severe congenital metabolic disorder

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Endpoint:<br /><br><br /><br>To determine the sensitivity and specificity of a host-response based<br /><br>diagnostics in differentiating between bacterial and viral etiology of<br /><br>pediatric patients aged 2 to 60 months with LRTI or FWS.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Endpoints:<br /><br><br /><br>To determine the sensitivity and specificity of a host-response based<br /><br>diagnostics in differentiating between infectious and non-infectious disease of<br /><br>pediatric patients aged 2 to 60 months.<br /><br>To determine the sensitivity and specificity of a host-response based<br /><br>diagnostics in differentiating between bacterial and viral etiology of<br /><br>pediatric patients aged 1 to 60 months with LRTI or FWS.<br /><br>No data are available for children age 1-2 months. This study aims to determine<br /><br>the sensitivity and specificity of a host-response based diagnostics in<br /><br>differentiating between bacterial and viral etiology of pediatric patients aged<br /><br>1 to 60 months with LRTI or FWS.</p><br>