CROCODILE-I: A Combinatorial Biomarker for Infection Diagnosis in Children

Sponsor

Universität des Saarlandes (Other)

Overall Status

Recruiting

CT.gov ID

NCT05971901

Collaborator

(none)

770

Enrollment

Locations

20.2

Anticipated Duration (Months)

192.5

Patients Per Site

9.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Respiratory Tract Infections Fever	Diagnostic Test: BV

Study Design

Study Type:

Observational

Anticipated Enrollment :

770 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Combinatorial Biomarker for Infection Diagnosis in Children

Actual Study Start Date :

Feb 24, 2023

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Antibiotics [up to 30 days]
Number of participants treated with antibiotics

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Months and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Sana Kliniken	Berlin	Germany
2	Universitätsklinikum Bonn	Bonn	Germany
3	Saarland University	Homburg	Germany	66421
4	Universitätsklinikum Würzburg	Würzburg	Germany

Sponsors and Collaborators

Universität des Saarlandes

Investigators

Principal Investigator: Cihan Papan, MD, Universität des Saarlandes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cihan Papan, Principial Investigator, Universität des Saarlandes

ClinicalTrials.gov Identifier:

NCT05971901

Other Study ID Numbers:

233/22

First Posted:

Aug 2, 2023

Last Update Posted:

Aug 2, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infections

Communicable Diseases

Respiratory Tract Infections

Study Results

No Results Posted as of Aug 2, 2023