A Combinatorial Biomarker for Infection Diagnosis in Children

NCT05971901 | Unknown

• 1 other identifier: 233/22
• Study Type: observational
• Target: 770
• Locations: 1 country
• Sites: 4

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).

Conditions

Respiratory Tract Infections; Fever

Outcome Measures

Primary Outcomes (1)

• Antibiotics

  Number of participants treated with antibiotics

  up to 30 days

Secondary Outcomes (4)

• Antibiotic duration

  up to 30 days

• Hospitalization

  up to 30 days

• Complications

  up to 30 days

• Tests

  up to 30 days

Study Arms (2)

BV use cases

cases in whom BV was ordered

Diagnostic Test: BV

BV non-use cases

cases in whom BV was not ordered

Interventions

BV DIAGNOSTIC_TEST

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

BV use cases

Eligibility Criteria

• Age: 5 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Suspicion of acute bacterial or viral infection
• Requirement of at least one BV test during medical presentation

You may not qualify if:

• lack of informed consent

Sponsors & Collaborators

• Universität des Saarlandes: lead

Study Sites (4)

Sana Kliniken

Berlin, Germany

NOT YET RECRUITING

Universitätsklinikum Bonn

Bonn, Germany

NOT YET RECRUITING

Saarland University

Homburg, 66421, Germany

RECRUITING

Universitätsklinikum Würzburg

Würzburg, Germany

NOT YET RECRUITING

MeSH Terms

Conditions

Respiratory Tract Infections; Fever

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cihan Papan, MD

  Universität des Saarlandes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cihan Papan, MD

CONTACT

+4968411623900; cihan.papan@uni-saarland.de

Soeren Becker, MD, PhD

CONTACT

+4968411623901; soeren.becker@uks.eu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principial Investigator

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 2, 2023
• Study Start: February 24, 2023
• Primary Completion: October 1, 2024
• Study Completion: November 1, 2024
• Last Updated: August 2, 2023

Record last verified: 2023-08

Locations

DE (4)