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

NCT05399615 | Withdrawn

• 1 other identifier: ID-PMC-2021
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Infectious Disease

Outcome Measures

Primary Outcomes (1)

• Discovery of exhaled breath biomarkers

  To evaluate the sensitivity, specificity, positive and negative predictive value of metabolomic biomarkers in exhaled breath samples as compared with pathogens biomarkers found in participants' blood and sputum samples.

  Through the study completion, up to 3 months.

Secondary Outcomes (1)

• The association of exhaled biomarkers with inflammatory known biomarkers.

  Through the study completion, up to 3 months.

Study Arms (2)

Hospitalized Patients

EXPERIMENTAL

Patients hospitalized in internal ward at "Poriya" Medical Center

Diagnostic Test: VOX

Controls

EXPERIMENTAL

Healthy volunteers

Diagnostic Test: VOX

Interventions

VOX DIAGNOSTIC_TEST

Breath biopsy

Controls; Hospitalized Patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Scentech Medical Technologies Ltd: lead

Study Sites (1)

Poriya Medical Center

Poria – Neve Oved, 1528001, Israel

Location

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Avi Peretz, PhD

  Poriya Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: parallel assignment

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: June 1, 2022
• Study Start: December 30, 2022
• Primary Completion: May 31, 2023
• Study Completion: July 31, 2023
• Last Updated: May 16, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)