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Clinical Trials in Italy / NCT07303400
Active, not recruiting Observational

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

NCT07303400 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Phase
Observational
Started
2025-06-09
Last updated
2026-03-25

Condition(s) studied

Lower Resp Tract Infection

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
Fondazione IRCCS Policlinico San Matteo di Pavia Pavia Pavia

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07303400 on ClinicalTrials.gov ↗ ← All trials in Italy