A Combinatorial Biomarker for Infection Diagnosis in Children

NCT ID: NCT05971901

Last Updated: 2023-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

770 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-24

Study Completion Date

2024-11-30

Brief Summary

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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).

Detailed Description

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Conditions

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Respiratory Tract Infections Fever

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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BV use cases

cases in whom BV was ordered

BV

Intervention Type DIAGNOSTIC_TEST

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

No interventions assigned to this group

Interventions

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BV

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

5 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universität des Saarlandes

OTHER

Sponsor Role lead

Responsible Party

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Cihan Papan

Principial Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cihan Papan, MD

Role: PRINCIPAL_INVESTIGATOR

Universität des Saarlandes

Locations

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Sana Kliniken

Berlin, , Germany

Site Status NOT_YET_RECRUITING

Universitätsklinikum Bonn

Bonn, , Germany

Site Status NOT_YET_RECRUITING

Saarland University

Homburg, , Germany

Site Status RECRUITING

Universitätsklinikum Würzburg

Würzburg, , Germany

Site Status NOT_YET_RECRUITING

Countries

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Germany

Central Contacts

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Cihan Papan, MD

Role: CONTACT

+4968411623900

Soeren Becker, MD, PhD

Role: CONTACT

+4968411623901

Facility Contacts

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Tobias Tenenbaum, MD

Role: primary

00493055185131

Cihan Papan, MD

Role: primary

004922828714639

Cihan Papan, MD

Role: primary

004968411623900

Soeren Becker, MD, PhD

Role: backup

004968411623900

Johannes Liese, MD

Role: primary

004993120127725

Other Identifiers

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233/22

Identifier Type: -

Identifier Source: org_study_id

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