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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Active, not recruiting

Conditions: Lower Resp Tract Infection

Study type: Observational

Funder types: Other

Identifiers

NCT07303400

ASAP

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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