HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Array
NCT ID: NCT05952648
Last Updated: 2025-08-14
Study Results
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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RECRUITING
NA
126 participants
INTERVENTIONAL
2024-04-03
2026-04-01
Brief Summary
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Detailed Description
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In patients with sepsis and septic shock, early and appropriate antibiotics are essential for improving clinical outcome, often requiring the use of broad-spectrum combinations.
The optimal use of antimicrobials is part of current implementation programs aimed to reduce the administration of not-necessary antibiotics, the bio-ecologic pressure and the possible side effects .
In this context the application of rapid, molecular microbiological tests on respiratory samples is of overwhelming interest, due to the potential of reducing the time to inappropriate antibiotic therapy and of prompting de-escalation.
During last years a new Multiplex PCR Assay for pneumonia diagnosis (Film-Array Pneumonia Panel Plus, BioFire, Salt Lake City, UT, USA) has been implementing in the clinical practice, showing very high rates of negative and positive predictive values.
The hypothesis is that molecular test on lower respiratory tract samples may reduce the time to microbiological diagnosis, thus allowing early antibiotic de-escalation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Film-array Pneumonia Panel Plus group
Patients with suspected HAP or VAP in which lower tract respiratory samples are analyzed with new multiplex PCR assay (Film-array Pneumonia Panel Plus)
Lower tract respiratory samples
Within 1 hour from HAP or VAP suspicion, quantitative tracheal aspirate or bronchoalveolar lavage will be performed to confirm the diagnosis. Clinicians will be encouraged to perform BAL whenever possible
Multiplex PCR assay (Film-array Pneumonia Panel Plus)
The lower tract respiratory samples will be analyzed with Multiplex PCR assay (Film-array Pneumonia Plus).
Lower respiratory tract standard culture
The lower tract respiratory samples will be analyzed using convention microbiological methods (including conventional Gram stain and semiquantitative culture on both selective/differential and screening agar media)
Blood sample standard culture
When HAP or VAP are suspected, blood samples from peripheral vein will be collected and analyzed with conventional microbiological methods
Standard culture group (control group)
Patients with suspected HAP or VAP in which lower tract respiratory samples are analyzed with standard culture
Lower tract respiratory samples
Within 1 hour from HAP or VAP suspicion, quantitative tracheal aspirate or bronchoalveolar lavage will be performed to confirm the diagnosis. Clinicians will be encouraged to perform BAL whenever possible
Lower respiratory tract standard culture
The lower tract respiratory samples will be analyzed using convention microbiological methods (including conventional Gram stain and semiquantitative culture on both selective/differential and screening agar media)
Blood sample standard culture
When HAP or VAP are suspected, blood samples from peripheral vein will be collected and analyzed with conventional microbiological methods
Interventions
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Lower tract respiratory samples
Within 1 hour from HAP or VAP suspicion, quantitative tracheal aspirate or bronchoalveolar lavage will be performed to confirm the diagnosis. Clinicians will be encouraged to perform BAL whenever possible
Multiplex PCR assay (Film-array Pneumonia Panel Plus)
The lower tract respiratory samples will be analyzed with Multiplex PCR assay (Film-array Pneumonia Plus).
Lower respiratory tract standard culture
The lower tract respiratory samples will be analyzed using convention microbiological methods (including conventional Gram stain and semiquantitative culture on both selective/differential and screening agar media)
Blood sample standard culture
When HAP or VAP are suspected, blood samples from peripheral vein will be collected and analyzed with conventional microbiological methods
Eligibility Criteria
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Inclusion Criteria
* Availability to perform tracheal aspirates or broncoalveolar lavage within 1 hour from clinical suspicion
* Life expectancy ≥ 48 hours
* Signed written informed consent.
Exclusion Criteria
* Concomitant participating in other interventional trial
* Refusal to sign informed consent
18 Years
ALL
No
Sponsors
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Catholic University of the Sacred Heart
OTHER
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Principal Investigators
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Gennaro De Pascale, MD
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico A. Gemelli IRCCS
Massimo Antonelli, MD
Role: STUDY_CHAIR
Fondazione Policlinico A. Gemelli IRCCS
Locations
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S. Orsola Research Hospital
Bologna, , Italy
Ospedale Careggi
Florence, , Italy
Modena Policlinico
Modena, , Italy
Fondazione Policlinico Universitario "A. GEMELLI" IRCCS
Roma, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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5768
Identifier Type: -
Identifier Source: org_study_id
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