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

May 14, 2023 updated by: Scentech Medical Technologies Ltd
Detection of bacterial and viral pathogens infection among hospitalized patients using breath analysis - feasibility study.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Poriyya, Israel, 1528001
        • Poriya Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hospitalized Patients
Patients hospitalized in internal ward at "Poriya" Medical Center
Diagnostic test: VOX
Breath biopsy
Experimental: Controls
Healthy volunteers
Diagnostic test: VOX
Breath biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discovery of exhaled breath biomarkers
Time Frame: Through the study completion, up to 3 months.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The association of exhaled biomarkers with inflammatory known biomarkers.
Time Frame: Through the study completion, up to 3 months.
To measure the association between exhaled biomarkers and inflammatory known biomarkers that are found in participants' blood and sputum samples.
Through the study completion, up to 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scentech Medical Technologies Ltd

Investigators

  • Principal Investigator: Avi Peretz, PhD, Poriya Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 30, 2022

Primary Completion (Anticipated)

May 31, 2023

Study Completion (Anticipated)

July 31, 2023

Study Registration Dates

First Submitted

May 24, 2022

First Submitted That Met QC Criteria

May 26, 2022

First Posted (Actual)

June 1, 2022

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 14, 2023

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID-PMC-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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