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

NCT07303400 | Active Not Recruiting

• 1 other identifier: ASAP
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Lower Resp Tract Infection

Outcome Measures

Primary Outcomes (2)

• 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 (1)

• anticipation time

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients tested for Lower Respiratory tract infections using bronchoalveolar lavage samples

You may qualify if:

• 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)
• µL of lower respiratory tract sample (e.g. Bronchoalveolar lavage) are available after the routine diagnostic procedures are over

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, Pavia, 27100, Italy

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 24, 2025
• Study Start: June 9, 2025
• Primary Completion: December 31, 2025
• Study Completion: May 1, 2026
• Last Updated: March 25, 2026

Record last verified: 2025-08

Locations

IT (1)