Active — Not RecruitingNot Applicable

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

Italy100 participantsStarted 2025-06-09

Plain-language 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

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

test positivity

Timeframe: Baseline

species identification

Timeframe: Baseline

Trial details

NCT IDNCT07303400

SponsorFondazione IRCCS Policlinico San Matteo di Pavia

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Lower Resp Tract Infection trials