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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05952648
Other study ID # 5768
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 3, 2024
Est. completion date April 1, 2025

Study information

Verified date May 2024
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Gennaro De Pascale, MD
Phone +393208998173
Email gennaro.depascale@policlinicogemelli.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Multicenter, randomized, controlled, open-label trial to assess if semiquantitative multiplex PCR assay, as compared to conventional microbiology, can reduce the percentage of patients without microbiological diagnosis in the first 24 hours from HAP/VAP suspicion, thus allowing early de-escalation.


Description:

Hospital-acquired pneumonia and ventilator-associated pneumonia are leading cause of morbidity and mortality in Intensive Care Unit due to the underlining clinical conditions of critically ill patients and the high rate of multidrug resistance among causative agents. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 126
Est. completion date April 1, 2025
Est. primary completion date April 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Suspicion of HAP/VAP (clinical/radiological/laboratory 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: - Pregnancy, - Concomitant participating in other interventional trial - Refusal to sign informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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
Diagnostic Test:
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

Locations

Country Name City State
Italy S. Orsola Research Hospital Bologna
Italy Ospedale Careggi Firenze
Italy Modena Policlinico Modena
Italy Fondazione Policlinico Universitario "A. GEMELLI" IRCCS Roma

Sponsors (2)

Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients without microbiological diagnosis of HAP/VAP within the first 24 hours Proportion of patients where a microbiological diagnosis of HAP/VAP is not avaiable within the first 24 hours 24 hours
Secondary Rate of antibiotic de-escalation as a consequence of microbiological results Proportion of patients in which antibiotic therapy has been modified from broad-spectrum empirical to targeted, due to microbiological results 4 days
Secondary Time to antibiotic de-escalation and optimal therapy Period of time from empirical antibiotic therapy initiation to modification due to microbiological results 4 days
Secondary Mechanical Ventilation free-days Number of days from enrollment in which the patients is not mechanically ventilated 14 and 28 days
Secondary Rate of MDR infection Proportion of patients who suffered from infection caused by multidrug resistant germ 28 days
Secondary Lenght of intensive care unit stay Period of time from enrollment in which the patient is admitted to the intensive care unit 60 days
Secondary Lenght of hospital stay Period of time from enrollment in which the patient is admitted to the hospital 60 days
Secondary In-Intensive care unit mortality All-cause mortality, assessed during ICU stay 28 days and 60 days
Secondary 28 days and 60 days mortality All-cause mortality 28 days and 60 days
Secondary SOFA score Measured SOFA score after 2,3,7 and 14 days from enrollment 14 days
Secondary Diagnostic concordance Proportion of patients in the interventional group, in which microbiological diagnosis is concordant when assessed with PCR array and standard culture 4 days
Secondary Adverse event Proportion of patients in which any adverse event is registered 28 days
Secondary In-Hospital mortality All-cause mortality, assessed during Hospital stay 28 days and 60 days
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