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

March 24, 2026 updated by: Stefano Gaiarsa, Fondazione IRCCS Policlinico San Matteo di Pavia
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 Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Pavia
      • Pavia, Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo di Pavia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients tested for Lower Respiratory tract infections using bronchoalveolar lavage samples

Description

Inclusion Criteria:

  1. Willingness and ability to provide written informed consent prior to performing the study procedures
  2. Patients older than 18 years of age
  3. Suspected bacterial Lower Respiratory Infection (LRI)
  4. 500µL of lower respiratory tract sample (e.g. Bronchoalveolar lavage) are available after the routine diagnostic procedures are over

Exclusion Criteria:

  1. Low amount of leftover specimen
  2. Complex diagnosis: clinicians could require further analysis after the first diagnosis is produced
  3. A sample of the same patient has been already included in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2025

Primary Completion (Actual)

December 31, 2025

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

December 2, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Actual)

December 24, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • ASAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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