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A Combinatorial Biomarker for Infection Diagnosis in Children

A Combinatorial Biomarker for Infection Diagnosis in Children

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05971901
Acronym
CROCODILE-I
Enrollment
770
Registered
2023-08-02
Start date
2023-02-24
Completion date
2024-11-30
Last updated
2023-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fever, Respiratory Tract Infections

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).

Interventions

DIAGNOSTIC_TESTBV

The use of the BV test, ordered at the discretion of the treating physician

Sponsors

Universität des Saarlandes
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Months to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Antibioticsup to 30 daysNumber of participants treated with antibiotics

Secondary

MeasureTime frameDescription
Antibiotic durationup to 30 daysLength of antibiotic treatment per participant
Hospitalizationup to 30 daysNumber of participants admitted to the hospital
Complicationsup to 30 daysRate of complications per participant
Testsup to 30 daysRate of ancillary tests per participant

Countries

Germany

Contacts

Primary ContactCihan Papan, MD
cihan.papan@uni-saarland.de+4968411623900
Backup ContactSoeren Becker, MD, PhD
soeren.becker@uks.eu+4968411623901

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026