A Combinatorial Biomarker for Infection Diagnosis in Chil... | NCT05971901

Studies
A Combinatorial Biomarker for Infection Diagnosis in Children

NCT05971901

Sponsor

Universität des Saarlandes

Status

Unknown status

Last Update Posted

Aug 2, 2023Actual

Enrollment

770Estimated

Phase

Not provided

Conditions

Respiratory Tract Infections
Fever

Interventions

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 24, 2023Actual

Primary Completion Date

Oct 2024Estimated

Completion Date

Nov 2024Estimated

First Submitted Date

Jul 24, 2023

First Submission Date that Met QC Criteria

Aug 1, 2023

First Posted Date

Aug 2, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2023

Last Update Posted Date

Aug 2, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Cihan Papan, Principial Investigator, Universität des SaarlandesPrincipal Investigator

Lead Sponsor

Universität des SaarlandesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

770Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BV use cases		cases in whom BV was ordered	Diagnostic Test: BV
BV non-use cases		cases in whom BV was not ordered

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BV	Diagnostic Test	The use of the BV test, ordered at the discretion of the treating physician	BV use cases

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Antibiotic duration	Length of antibiotic treatment per participant	up to 30 days
Hospitalization	Number of participants admitted to the hospital

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Months

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Cihan Papan, MD	Contact	+4968411623900		cihan.papan@uni-saarland.de
Soeren Becker, MD, PhD	Contact	+4968411623901		soeren.becker@uks.eu

Overall Officials

Name	Affiliation	Role
Cihan Papan, MD	Universität des Saarlandes	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sana Kliniken	Not yet recruiting	Berlin			Germany

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012141	Respiratory Tract Infections
D005334	Fever

Ancestor Terms

ID	Term
D007239	Infections
D012140	Respiratory Tract Diseases
D001832	Body Temperature Changes
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided