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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07303400

Enrollment

100

Registered

2025-12-24

Start date

2025-06-09

Completion date

2026-05-01

Last updated

2026-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Resp Tract Infection

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Secondary

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

Countries

Italy

Outcome results