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NCT05971901 Clinical Trial

A Combinatorial Biomarker for Infection Diagnosis in Children

Fever Clinical Trial

— CROCODILE-I  

Official title:
A Combinatorial Biomarker for Infection Diagnosis in Children

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05971901
Other study ID # 233/22
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 24, 2023
Est. completion date November 2024

Study information
Verified date August 2023
Source Universität des Saarlandes
Contact Cihan Papan, MD
Phone +4968411623900
Email cihan.papan@uni-saarland.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Recruiting
Enrollment 770
Est. completion date November 2024
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 5 Months and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• BV
The use of the BV test, ordered at the discretion of the treating physician

Locations
Country Name City State
Germany Sana Kliniken Berlin
Germany Universitätsklinikum Bonn Bonn
Germany Saarland University Homburg
Germany Universitätsklinikum Würzburg Würzburg

Sponsors (1)
Lead Sponsor Collaborator
Universität des Saarlandes

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Antibiotics Number of participants treated with antibiotics up to 30 days
Secondary Antibiotic duration Length of antibiotic treatment per participant up to 30 days
Secondary Hospitalization Number of participants admitted to the hospital up to 30 days
Secondary Complications Rate of complications per participant up to 30 days
Secondary Tests Rate of ancillary tests per participant up to 30 days
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