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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05399615

Acronym

Infection

Enrollment

Registered

2022-06-01

Start date

2022-12-30

Completion date

2023-07-31

Last updated

2023-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infectious Disease

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.

Interventions

DIAGNOSTIC_TESTVOX

Breath biopsy

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

parallel assignment

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026