A Combinatorial Biomarker for Infection Diagnosis in Children (CROCODILE-I)

Universität des Saarlandes

Status: Enrolling

Conditions: Fever; Respiratory Tract Infections

Treatments: Diagnostic Test: BV

Study type: Observational

Funder types: Other

Identifiers

NCT05971901

233/22

Details and patient eligibility

About

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).

Enrollment: 770 estimated patients

Sex: All

Ages: 5+ months old

Volunteers: No Healthy Volunteers

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

Trial design

770 participants in 2 patient groups

BV use cases

Description:

cases in whom BV was ordered

Treatment:

Diagnostic Test: BV

BV non-use cases

Description:

cases in whom BV was not ordered