Lower tract respiratory samples
ProcedureWithin 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
NCT Number: NCT05952648
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
S. Orsola Research Hospital, Bologna, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
The lower tract respiratory samples will be analyzed with Multiplex PCR assay (Film-array Pneumonia Plus).
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)
When HAP or VAP are suspected, blood samples from peripheral vein will be collected and analyzed with conventional microbiological methods
Time frame: 24 hours
Proportion of patients where a microbiological diagnosis of HAP/VAP is not avaiable within the first 24 hours
Time frame: 4 days
Proportion of patients in which antibiotic therapy has been modified from broad-spectrum empirical to targeted, due to microbiological results
Time frame: 4 days
Period of time from empirical antibiotic therapy initiation to modification due to microbiological results
Time frame: 14 and 28 days
Number of days from enrollment in which the patients is not mechanically ventilated
Time frame: 28 days
Proportion of patients who suffered from infection caused by multidrug resistant germ
Time frame: 60 days
Period of time from enrollment in which the patient is admitted to the intensive care unit
Time frame: 60 days
Period of time from enrollment in which the patient is admitted to the hospital
Time frame: 28 days and 60 days
All-cause mortality, assessed during ICU stay
Time frame: 28 days and 60 days
All-cause mortality
Time frame: 14 days
Measured SOFA score after 2,3,7 and 14 days from enrollment
Time frame: 4 days
Proportion of patients in the interventional group, in which microbiological diagnosis is concordant when assessed with PCR array and standard culture
Time frame: 28 days
Proportion of patients in which any adverse event is registered
Time frame: 28 days and 60 days
All-cause mortality, assessed during Hospital stay
Contact information is provided by the study sponsor or research team.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Other
HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Assay: A Multicenter Randomized Open-Label Trial. THE LIGHTNING STUDY
Acronym: LIGHTNING
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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