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NCT05399615 Clinical Trial

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

Infectious Disease Clinical Trial

— Infection  

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT05399615
Other study ID # ID-PMC-2021
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date December 30, 2022
Est. completion date July 31, 2023

Study information
Verified date May 2022
Source Scentech Medical Technologies Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date July 31, 2023
Est. primary completion date May 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• VOX
Breath biopsy

Locations
Country Name City State
Israel Poriya Medical Center Poriyya

Sponsors (1)
Lead Sponsor Collaborator
Scentech Medical Technologies Ltd

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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. Through the study completion, up to 3 months.
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