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

NCT ID: NCT07303400

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-09

Study Completion Date

2025-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Lower Resp Tract Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role lead

Responsible Party

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Stefano Gaiarsa

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, Pavia, Italy

Site Status

Countries

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Italy

Other Identifiers

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ASAP

Identifier Type: -

Identifier Source: org_study_id