HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Array
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lower tract respiratory samples, Multiplex PCR assay (Film-array Pneumonia Panel Plus), Lower respiratory tract standard culture, Blood sample standard culture.
- Who it may be relevant to
- Registry conditions: HAP - Hospital Acquired Pneumonia, VAP - Ventilator Associated Pneumonia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Assay: A Multicenter Randomized Open-Label Trial. THE LIGHTNING STUDY
Overview
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.
Interventions
- 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). - Diagnostic test 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) - Diagnostic test Blood sample standard culture
When HAP or VAP are suspected, blood samples from peripheral vein will be collected and analyzed with conventional microbiological methods
Primary outcome measures
- Proportion of patients without microbiological diagnosis of HAP/VAP within the first 24 hours [Time frame: 24 hours]
Secondary outcome measures (12)
- Rate of antibiotic de-escalation as a consequence of microbiological results [Time frame: 4 days]
- Time to antibiotic de-escalation and optimal therapy [Time frame: 4 days]
- Mechanical Ventilation free-days [Time frame: 14 and 28 days]
- Rate of MDR infection [Time frame: 28 days]
- Lenght of intensive care unit stay [Time frame: 60 days]
- Lenght of hospital stay [Time frame: 60 days]
- In-Intensive care unit mortality [Time frame: 28 days and 60 days]
- 28 days and 60 days mortality [Time frame: 28 days and 60 days]
- SOFA score [Time frame: 14 days]
- Diagnostic concordance [Time frame: 4 days]
- Adverse event [Time frame: 28 days]
- In-Hospital mortality [Time frame: 28 days and 60 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Italy · 4 centers
- S. Orsola Research Hospital — Bologna
- Ospedale Careggi — Florence
- Modena Policlinico — Modena
- Fondazione Policlinico Universitario "A. GEMELLI" IRCCS — Roma
Identifiers
NCT: NCT05952648 · 5768