Lower Resp Tract InfectionNCT07303400
Assessment of the Effectiveness of a Prototype Diagnostic System of Bacterial Respiratory Infections Based on Real-time Sequencing
An observational study of Lower Resp Tract Infection, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
The objective of this project is to test the efficiency of a novel developed protocol for direct real-time metagenomic sequencing of Lower Respiratory Infection samples. The investigators aim to assess the anticipation time, compared to the traditional culturing methods and the accuracy, compared to gold standards Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Resp Tract Infection
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 9 Jun 2025to May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients tested for Lower Respiratory tract infections using bronchoalveolar lavage samples
Who may be able to join
- Willingness and ability to provide written informed consent prior to performing the study procedures
- Patients older than 18 years of age
- Suspected bacterial Lower Respiratory Infection (LRI)
- 500µL of lower respiratory tract sample (e.g. Bronchoalveolar lavage) are available after the routine diagnostic procedures are over
Who cannot join
- Low amount of leftover specimen
- Complex diagnosis: clinicians could require further analysis after the first diagnosis is produced
- A sample of the same patient has been already included in the study
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Pavia, 27100
About this study
The objective of this project is to test the efficiency of a novel developed protocol for direct real-time metagenomic sequencing of Lower Respiratory Infection samples. The investigators aim to assess the anticipation time, compared to the traditional culturing methods and the accuracy, compared to gold standards
- Conditions
- Lower Resp Tract Infection
What is being measured
The primary outcome is the main question the study is designed to answer.
test positivity
assess the effectiveness in detection of positive (Gram+ vs Gram- vs mixed culture samples) vs negative samples
Measured: Baseline
species identification
Assess the effectiveness in recognizing the correct bacterial species
Measured: Baseline
Secondary outcomes (1)
anticipation time
Measure the anticipation time of the novel protocol vs gold standard (culturing)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start9 Jun 2025
- Primary completion31 Dec 2025
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Resp Tract InfectionStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Gaiarsa, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303400
- Sponsor's protocol ID
- ASAP
- Status last verified
- Aug 2025
- First submitted
- 2 Dec 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effectiveness of a Prototype Diagnostic System of Bacterial Respiratory Infections Based on Real-time Sequencing
- ClinicalTrials.gov ID
- NCT07303400
- Acronym / sponsor ID
- ASAP
- Conditions
- Lower Resp Tract Infection
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 9 Jun 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- May 2026 (estimated)
- First posted
- 24 Dec 2025 (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.
The objective of this project is to test the efficiency of a novel developed protocol for direct real-time metagenomic sequencing of Lower Respiratory Infection samples. The investigators aim to assess the anticipation time, compared to the traditional culturing methods and the accuracy, compared to gold standards
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients tested for Lower Respiratory tract infections using bronchoalveolar lavage samples
Key inclusion criteria (4 listed)
- Willingness and ability to provide written informed consent prior to performing the study procedures
- Patients older than 18 years of age
- Suspected bacterial Lower Respiratory Infection (LRI)
- 500µL of lower respiratory tract sample (e.g. Bronchoalveolar lavage) are available after the routine diagnostic procedures are over
Key exclusion criteria (3 listed)
- Low amount of leftover specimen
- Complex diagnosis: clinicians could require further analysis after the first diagnosis is produced
- A sample of the same patient has been already included in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
test positivity
Time frame: Baseline
assess the effectiveness in detection of positive (Gram+ vs Gram- vs mixed culture samples) vs negative samples
species identification
Time frame: Baseline
Assess the effectiveness in recognizing the correct bacterial species
1 secondary outcome
anticipation time
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Resp Tract Infection, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 25 Mar 2026. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
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?
test positivity (time frame: Baseline). The study lists 2 primary outcomes in all. 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 25 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.