Detection of Bacterial and Viral Pathogens Infection Among Hospitalized Patients Feasibility Study

NCT ID: NCT05399615

Last Updated: 2023-05-16

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-30

Study Completion Date

2023-07-31

Brief Summary

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Detection of bacterial and viral pathogens infection among hospitalized patients using breath analysis - feasibility study.

Detailed Description

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A diagnostic prospective single-site study, with no anticipated risks or constraints.

Primary objective: To identify a set of breath Volatile Organic Compound biomarkers that enable the detection of pathogens infection and inflammatory response to pathogens infection among hospitalized patients.

Conditions

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Infectious Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

parallel assignment
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Hospitalized Patients

Patients hospitalized in internal ward at "Poriya" Medical Center

Group Type EXPERIMENTAL

VOX

Intervention Type DIAGNOSTIC_TEST

Breath biopsy

Controls

Healthy volunteers

Group Type EXPERIMENTAL

VOX

Intervention Type DIAGNOSTIC_TEST

Breath biopsy

Interventions

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VOX

Breath biopsy

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age 18 to 80 years at the time of consent
* Capable of understanding written and/or spoken language
* Able to provide informed consent
* Negative results for SARS-CoV-2
* Diagnosed with suspected respiratory infection

Exclusion Criteria

* Under guardianship or deprived of liberty
* Pregnant or lactating woman
* Not able to breathe through mask for 8 minutes
* Intubated patients
* Patients in critical condition
* Diagnosed with hospital-acquired infection
* Medical history of malignancies
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Scentech Medical Technologies Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Avi Peretz, PhD

Role: PRINCIPAL_INVESTIGATOR

Poriya Medical Center

Locations

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Poriya Medical Center

Poria – Neve Oved, , Israel

Site Status

Countries

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Israel

Other Identifiers

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ID-PMC-2021

Identifier Type: -

Identifier Source: org_study_id

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