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Clinical Trials/NCT05399615
NCT05399615WithdrawnNot Applicable

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

Scentech Medical Technologies Ltd2 sites in 1 countryStarted: December 30, 2022Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Sponsor
Locations
2
Primary Endpoint
Discovery of exhaled breath biomarkers
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

Discovery of exhaled breath biomarkers

Time Frame: 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 Outcomes

  • The association of exhaled biomarkers with inflammatory known biomarkers.(Through the study completion, up to 3 months.)

Investigators

Sponsor
Scentech Medical Technologies Ltd
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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Detection of Bacterial and Viral Pathogens... | Clinical Trial