Detection of Bacterial and Viral Pathogens Infection Among Hospitalized Patients Feasibility Study (Infection)
Primary Purpose
Infectious Disease
Status
Withdrawn
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
VOX
Sponsored by
About this trial
This is an interventional diagnostic trial for Infectious Disease
Eligibility Criteria
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
Sites / Locations
- Poriya Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Hospitalized Patients
Controls
Arm Description
Patients hospitalized in internal ward at "Poriya" Medical Center
Healthy volunteers
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
The association of exhaled biomarkers with inflammatory known biomarkers.
To measure the association between exhaled biomarkers and inflammatory known biomarkers that are found in participants' blood and sputum samples.
Full Information
NCT ID
NCT05399615
First Posted
May 24, 2022
Last Updated
May 14, 2023
Sponsor
Scentech Medical Technologies Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05399615
Brief Title
Detection of Bacterial and Viral Pathogens Infection Among Hospitalized Patients Feasibility Study
Acronym
Infection
Official Title
Detection of Bacterial and Viral Pathogens Infection Among Hospitalized Patients Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Withdrawn
Why Stopped
the company decision
Study Start Date
December 30, 2022 (Anticipated)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Scentech Medical Technologies Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Detection of bacterial and viral pathogens infection among hospitalized patients using breath analysis - feasibility study.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infectious Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
parallel assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hospitalized Patients
Arm Type
Experimental
Arm Description
Patients hospitalized in internal ward at "Poriya" Medical Center
Arm Title
Controls
Arm Type
Experimental
Arm Description
Healthy volunteers
Intervention Type
Diagnostic Test
Intervention Name(s)
VOX
Intervention Description
Breath biopsy
Primary Outcome Measure Information:
Title
Discovery of exhaled breath biomarkers
Description
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.
Time Frame
Through the study completion, up to 3 months.
Secondary Outcome Measure Information:
Title
The association of exhaled biomarkers with inflammatory known biomarkers.
Description
To measure the association between exhaled biomarkers and inflammatory known biomarkers that are found in participants' blood and sputum samples.
Time Frame
Through the study completion, up to 3 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avi Peretz, PhD
Organizational Affiliation
Poriya Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Poriya Medical Center
City
Poriyya
ZIP/Postal Code
1528001
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No IPD
Learn more about this trial
Detection of Bacterial and Viral Pathogens Infection Among Hospitalized Patients Feasibility Study
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