Infectious DiseaseInfectionNCT05399615
Detection of Bacterial and Viral Pathogens Infection Among Hospitalized Patients Feasibility Study
A study testing VOX in people with Infectious Disease, run by Scentech Medical Technologies Ltd at 1 site in Israel.
Trial summary
Detection of bacterial and viral pathogens infection among hospitalized patients using breath analysis - feasibility study. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Infectious Disease
- What is being tested?
- VOX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- 30 Dec 2022to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Detection of bacterial and viral pathogens infection among hospitalized patients using breath analysis - feasibility study.
Read the 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.
- Conditions
- Infectious Disease
- Being tested
- VOX
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VOXDiagnostic test
Breath biopsy
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized Patients | Experimental | Patients hospitalized in internal ward at "Poriya" Medical Center Receives: Diagnostic Test: VOX |
| Controls | Experimental | Healthy volunteers Receives: Diagnostic Test: VOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through the study completion, up to 3 months.
Secondary outcomes (1)
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.
Measured: Through the study completion, up to 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start30 Dec 2022 (estimated)
- Primary completion31 May 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Why it stopped: the company decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- parallel assignment
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scentech Medical Technologies Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Avi Peretz, PhD, Principal investigator, Poriya Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399615
- Sponsor's protocol ID
- ID-PMC-2021
- Acronym
- Infection
- Status last verified
- May 2022
- First submitted
- 24 May 2022
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Bacterial and Viral Pathogens Infection Among Hospitalized Patients Feasibility Study
- ClinicalTrials.gov ID
- NCT05399615
- Acronym / sponsor ID
- Infection / ID-PMC-2021
- Conditions
- Infectious Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: the company decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Scentech Medical Technologies LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2022 (estimated)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Hospitalized Patients | Experimental | Diagnostic Test: VOXPatients hospitalized in internal ward at "Poriya" Medical Center |
| Controls | Experimental | Diagnostic Test: VOXHealthy volunteers |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VOXBreath biopsy | Diagnostic test | Controls, Hospitalized Patients |
Primary outcome
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.
1 secondary outcome
The association of exhaled biomarkers with inflammatory known biomarkers.
Time frame: Through the study completion, up to 3 months.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Individual participant dataSharing planned: No. No IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Avi Peretz, PhD principal investigator
Poriya Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VOX in people with Infectious Disease, run by Scentech Medical Technologies Ltd at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discovery of exhaled breath biomarkers (time frame: Through the study completion, up to 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.