HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Array
- Conditions
- VAP - Ventilator Associated PneumoniaHAP - Hospital Acquired Pneumonia
- Interventions
- Procedure: Lower tract respiratory samplesDiagnostic Test: Multiplex PCR assay (Film-array Pneumonia Panel Plus)Diagnostic Test: Lower respiratory tract standard cultureDiagnostic Test: Blood sample standard culture
- Registration Number
- NCT05952648
- Brief 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.
- Detailed 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 & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 126
- 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.
- Pregnancy,
- Concomitant participating in other interventional trial
- Refusal to sign informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Film-array Pneumonia Panel Plus group Blood sample standard culture Patients with suspected HAP or VAP in which lower tract respiratory samples are analyzed with new multiplex PCR assay (Film-array Pneumonia Panel Plus) Standard culture group (control group) Blood sample standard culture Patients with suspected HAP or VAP in which lower tract respiratory samples are analyzed with standard culture Film-array Pneumonia Panel Plus group Multiplex PCR assay (Film-array Pneumonia Panel Plus) Patients with suspected HAP or VAP in which lower tract respiratory samples are analyzed with new multiplex PCR assay (Film-array Pneumonia Panel Plus) Film-array Pneumonia Panel Plus group Lower respiratory tract standard culture Patients with suspected HAP or VAP in which lower tract respiratory samples are analyzed with new multiplex PCR assay (Film-array Pneumonia Panel Plus) Standard culture group (control group) Lower tract respiratory samples Patients with suspected HAP or VAP in which lower tract respiratory samples are analyzed with standard culture Film-array Pneumonia Panel Plus group Lower tract respiratory samples Patients with suspected HAP or VAP in which lower tract respiratory samples are analyzed with new multiplex PCR assay (Film-array Pneumonia Panel Plus) Standard culture group (control group) Lower respiratory tract standard culture Patients with suspected HAP or VAP in which lower tract respiratory samples are analyzed with standard culture
- Primary Outcome Measures
Name Time Method Proportion of patients without microbiological diagnosis of HAP/VAP within the first 24 hours 24 hours Proportion of patients where a microbiological diagnosis of HAP/VAP is not avaiable within the first 24 hours
- Secondary Outcome Measures
Name Time Method Adverse event 28 days Proportion of patients in which any adverse event is registered
In-Hospital mortality 28 days and 60 days All-cause mortality, assessed during Hospital stay
Lenght of intensive care unit stay 60 days Period of time from enrollment in which the patient is admitted to the intensive care unit
In-Intensive care unit mortality 28 days and 60 days All-cause mortality, assessed during ICU stay
28 days and 60 days mortality 28 days and 60 days All-cause mortality
Rate of antibiotic de-escalation as a consequence of microbiological results 4 days Proportion of patients in which antibiotic therapy has been modified from broad-spectrum empirical to targeted, due to microbiological results
Mechanical Ventilation free-days 14 and 28 days Number of days from enrollment in which the patients is not mechanically ventilated
Diagnostic concordance 4 days Proportion of patients in the interventional group, in which microbiological diagnosis is concordant when assessed with PCR array and standard culture
SOFA score 14 days Measured SOFA score after 2,3,7 and 14 days from enrollment
Time to antibiotic de-escalation and optimal therapy 4 days Period of time from empirical antibiotic therapy initiation to modification due to microbiological results
Rate of MDR infection 28 days Proportion of patients who suffered from infection caused by multidrug resistant germ
Lenght of hospital stay 60 days Period of time from enrollment in which the patient is admitted to the hospital
Trial Locations
- Locations (4)
Modena Policlinico
🇮🇹Modena, Italy
Ospedale Careggi
🇮🇹Firenze, Italy
S. Orsola Research Hospital
🇮🇹Bologna, Italy
Fondazione Policlinico Universitario "A. GEMELLI" IRCCS
🇮🇹Roma, Italy