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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Lower Resp Tract Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, 27100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Secondary outcomes

anticipation time

Time frame: Baseline

Measure the anticipation time of the novel protocol vs gold standard (culturing)

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2026
First posted: Dec 24, 2025
Registry last updated: Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting