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

• Sponsor: Scentech Medical Technologies Ltd (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05399615
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 7
• Patients Per Site Per Month: 17.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Infectious Disease	Diagnostic Test: VOX	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: parallel assignmentparallel assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Detection of Bacterial and Viral Pathogens Infection Among Hospitalized Patients Feasibility Study
• Anticipated Study Start Date: Dec 30, 2022
• Anticipated Primary Completion Date: May 31, 2023
• Anticipated Study Completion Date: Jul 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Discovery of exhaled breath biomarkers [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.

Secondary Outcome Measures

1. The association of exhaled biomarkers with inflammatory known biomarkers. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Poriya Medical Center	Poriyya		Israel	1528001

Sponsors and Collaborators

• Scentech Medical Technologies Ltd

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Scentech Medical Technologies Ltd
• ClinicalTrials.gov Identifier: NCT05399615
• Other Study ID Numbers: ID-PMC-2021
• First Posted: Jun 1, 2022
• Last Update Posted: Aug 9, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases

Study Results

No Results Posted as of Aug 9, 2022