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Clinical Trial Details — Status: Withdrawn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
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Infectious Disease

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.