Assessment of the Effectiveness of a Prototype Diagnostic... | NCT07303400

Studies
Assessment of the Effectiveness of a Prototype Diagnostic System of Bacterial Respiratory Infections Based on Real-time Sequencing

NCT07303400

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Status

Active, not recruiting

Last Update Posted

Mar 25, 2026Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Lower Resp Tract Infection

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 9, 2025Actual

Primary Completion Date

Dec 31, 2025Actual

Completion Date

May 2026Estimated

First Submitted Date

Dec 2, 2025

First Submission Date that Met QC Criteria

Dec 18, 2025

First Posted Date

Dec 24, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2026

Last Update Posted Date

Mar 25, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Stefano Gaiarsa, Researcher, Fondazione IRCCS Policlinico San Matteo di PaviaPrincipal Investigator

Lead Sponsor

Fondazione IRCCS Policlinico San Matteo di PaviaOTHER

Collaborators

Not provided

Description Module

Brief 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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
test positivity	assess the effectiveness in detection of positive (Gram+ vs Gram- vs mixed culture samples) vs negative samples	Baseline
species identification	Assess the effectiveness in recognizing the correct bacterial species	Baseline

Secondary Outcomes

Measure	Description	Time Frame
anticipation time	Measure the anticipation time of the novel protocol vs gold standard (culturing)	Baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients tested for Lower Respiratory tract infections using bronchoalveolar lavage samples

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondazione IRCCS Policlinico San Matteo di Pavia		Pavia	Pavia	27100	Italy