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

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).

Study Overview

• Status: Recruiting
• Conditions: Respiratory Tract Infections; Fever
• Intervention / Treatment: Diagnostic test: BV

• Study Type: Observational
• Enrollment (Estimated): 770

Contacts and Locations

• Study Contact: Name: Cihan Papan, MD; Phone Number: +4968411623900; Email: cihan.papan@uni-saarland.de
• Study Contact Backup: Name: Soeren Becker, MD, PhD; Phone Number: +4968411623901; Email: soeren.becker@uks.eu

Study Locations

• Germany
  • Berlin, Germany
    • Not yet recruiting
    • Sana Kliniken
    • Contact: Tobias Tenenbaum, MD; Phone Number: 00493055185131; Email: Tobias.Tenenbaum@Sana.de
  • Bonn, Germany
    • Not yet recruiting
    • Universitätsklinikum Bonn
    • Contact: Cihan Papan, MD; Phone Number: 004922828714639; Email: cihan.papan@ukbonn.de
  • Homburg, Germany, 66421
    • Recruiting
    • Saarland University
    • Contact: Cihan Papan, MD; Phone Number: 004968411623900; Email: cihan.papan@uni-saarland.de
    • Contact: Soeren Becker, MD, PhD; Phone Number: 004968411623900; Email: soeren.becker@uks.eu
  • Würzburg, Germany
    • Not yet recruiting
    • Universitatsklinikum Wurzburg
    • Contact: Johannes Liese, MD; Phone Number: 004993120127725; Email: Liese_J@ukw.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients for whom the treating physicians request the determination of the BV score from the patient's serum due to a suspected infection can be included in this study, provided that they meet the above inclusion criteria, are capable of giving consent and agree to participate in the study (or, in the case of incapacitated patients, written consent is obtained from their legal guardian, health care proxy or custodian).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
BV use cases; cases in whom BV was ordered	Diagnostic test: BV; The use of the BV test, ordered at the discretion of the treating physician
BV non-use cases; cases in whom BV was not ordered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibiotics	Number of participants treated with antibiotics	up to 30 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universität des Saarlandes
• Investigators: Principal Investigator: Cihan Papan, MD, Universität des Saarlandes

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: July 24, 2023
• First Submitted That Met QC Criteria: August 1, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: 233/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No