A Combinatorial Biomarker for Infection Diagnosis in Children

Recruiting

• Conditions: Respiratory Tract Infections; Fever
• Interventions: Diagnostic Test: BV

• Registration Number: NCT05971901
• Lead Sponsor: Universität des Saarlandes

Brief Summary

To describe the epidemiology, clinical presentation, diagnosis, therapy, and treatment outcomes of patients in whom the combination biomarker BV (combination of TRAIL, IP-10, and CRP) is used, and to compare them with control patients without BV measurement.

Secondary objectives:

* Qualitative evaluation of indication as well as adherence to the test result.

* Comparison of antimicrobial therapy, performed diagnostics, hospitalization, and outcomes between patients with high BV score (bacterial) and patients with low BV score (viral).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-24
• Study First Submitted: 2023-07-24
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-01
• Last Update Submitted: 2023-08-01
• Study First Posted: 2023-08-02
• Last Update Posted: 2023-08-02
• Primary Completion: 2024-10
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 770

Inclusion Criteria

• Suspicion of acute bacterial or viral infection
• Requirement of at least one BV test during medical presentation

Exclusion Criteria

• lack of informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BV use cases	BV	cases in whom BV was ordered

Primary Outcome Measures

Name	Time	Method
Antibiotics	up to 30 days	Number of participants treated with antibiotics

Secondary Outcome Measures

Name	Time	Method
Hospitalization	up to 30 days	Number of participants admitted to the hospital
Antibiotic duration	up to 30 days	Length of antibiotic treatment per participant
Complications	up to 30 days	Rate of complications per participant
Tests	up to 30 days	Rate of ancillary tests per participant

Trial Locations

Locations (4)

Saarland University; 🇩🇪 Homburg, Germany

Universitätsklinikum Bonn; 🇩🇪 Bonn, Germany

Sana Kliniken; 🇩🇪 Berlin, Germany

Universitätsklinikum Würzburg; 🇩🇪 Würzburg, Germany