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

Not Applicable

Withdrawn

• Conditions: Infectious Disease
• Interventions: Diagnostic Test: VOX

• Registration Number: NCT05399615
• Lead Sponsor: Scentech Medical Technologies Ltd

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.

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-24
• Study First Submitted QC: 2022-05-26
• Study First Posted: 2022-06-01
• Study Start: 2022-12-30
• Last Update Submitted: 2023-05-14
• Last Update Posted: 2023-05-16
• Primary Completion: 2023-05-31
• Study Completion: 2023-07-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Controls	VOX	Healthy volunteers
Hospitalized Patients	VOX	Patients hospitalized in internal ward at "Poriya" Medical Center

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Poriya Medical Center; 🇮🇱 Poriyya, Israel