HAP - Hospital Acquired PneumoniaLIGHTNINGNCT05952648
HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Array
A study testing Lower tract respiratory samples, Multiplex PCR assay (Film-array Pneumonia Panel Plus) and Lower respiratory tract standard culture in people with HAP - Hospital Acquired Pneumonia and VAP - Ventilator Associated Pneumonia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 4 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HAP - Hospital Acquired Pneumonia, VAP - Ventilator Associated Pneumonia
- What is being tested?
- Lower tract respiratory samples, Multiplex PCR assay (Film-array Pneumonia Panel Plus) and Lower respiratory tract standard culture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 4 sitesItaly
- Study dates
- 3 Apr 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnancy,
- Concomitant participating in other interventional trial
- Refusal to sign informed consent
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
S. Orsola Research Hospital
Bologna
Ospedale Careggi
Florence
Modena Policlinico
Modena
Fondazione Policlinico Universitario "A. GEMELLI" IRCCS
Roma, 00168
About this study
Official title: HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Assay: A Multicenter Randomized Open-Label Trial. THE LIGHTNING STUDY
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.
Read the 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.
- Being tested
- Lower tract respiratory samples, Multiplex PCR assay (Film-array Pneumonia Panel Plus), Lower respiratory tract standard culture, Blood sample standard culture
- Medical subject headings
- Healthcare-Associated Pneumonia, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower tract respiratory samplesProcedure or surgery
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)Diagnostic test
The lower tract respiratory samples will be analyzed with Multiplex PCR assay (Film-array Pneumonia Plus).
Lower respiratory tract standard cultureDiagnostic test
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 cultureDiagnostic test
When HAP or VAP are suspected, blood samples from peripheral vein will be collected and analyzed with conventional microbiological methods
| Study group | Role | What they receive |
|---|---|---|
| Film-array Pneumonia Panel Plus group | Experimental | Patients with suspected HAP or VAP in which lower tract respiratory samples are analyzed with new multiplex PCR assay (Film-array Pneumonia Panel Plus) Receives: Procedure: Lower tract respiratory samples; Diagnostic Test: Multiplex PCR assay (Film-array Pneumonia Panel Plus); Diagnostic Test: Lower respiratory tract standard culture; Diagnostic Test: Blood sample standard culture |
| Standard culture group (control group) | Active comparator | Patients with suspected HAP or VAP in which lower tract respiratory samples are analyzed with standard culture Receives: Procedure: Lower tract respiratory samples; Diagnostic Test: Lower respiratory tract standard culture; Diagnostic Test: Blood sample standard culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
Secondary outcomes (12)
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
Measured: 4 days
Time to antibiotic de-escalation and optimal therapy
Period of time from empirical antibiotic therapy initiation to modification due to microbiological results
Measured: 4 days
Mechanical Ventilation free-days
Number of days from enrollment in which the patients is not mechanically ventilated
Measured: 14 and 28 days
Rate of MDR infection
Proportion of patients who suffered from infection caused by multidrug resistant germ
Measured: 28 days
Lenght of intensive care unit stay
Period of time from enrollment in which the patient is admitted to the intensive care unit
Measured: 60 days
Lenght of hospital stay
Period of time from enrollment in which the patient is admitted to the hospital
Measured: 60 days
In-Intensive care unit mortality
All-cause mortality, assessed during ICU stay
Measured: 28 days and 60 days
28 days and 60 days mortality
All-cause mortality
Measured: 28 days and 60 days
SOFA score
Measured SOFA score after 2,3,7 and 14 days from enrollment
Measured: 14 days
Diagnostic concordance
Proportion of patients in the interventional group, in which microbiological diagnosis is concordant when assessed with PCR array and standard culture
Measured: 4 days
Adverse event
Proportion of patients in which any adverse event is registered
Measured: 28 days
In-Hospital mortality
All-cause mortality, assessed during Hospital stay
Measured: 28 days and 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start3 Apr 2024
- Primary completion5 Sep 2026
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HAP - Hospital Acquired PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled, multicenter, open-label trial
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Collaborators
- Catholic University of the Sacred Heart
- Responsible party
- Sponsor
- Investigators
- Gennaro De Pascale, MD, Principal investigator, Fondazione Policlinico A. Gemelli IRCCSMassimo Antonelli, MD, Study chair, Fondazione Policlinico A. Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05952648
- Sponsor's protocol ID
- 5768
- Acronym
- LIGHTNING
- Status last verified
- Sep 2026
- First submitted
- 5 Jul 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Assay: A Multicenter Randomized Open-Label Trial. THE LIGHTNING STUDY
- ClinicalTrials.gov ID
- NCT05952648
- Acronym / sponsor ID
- LIGHTNING / 5768
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Collaborators
- Catholic University of the Sacred Heart
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 5 Sep 2026 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 19 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled, multicenter, open-label trial
| Arm | Type | Receives |
|---|---|---|
| Film-array Pneumonia Panel Plus group | Experimental | Procedure: Lower tract respiratory samples, Diagnostic Test: Multiplex PCR assay (Film-array Pneumonia Panel Plus), Diagnostic Test: Lower respiratory tract standard culture, Diagnostic Test: Blood sample standard culturePatients 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) | Active comparator | Procedure: Lower tract respiratory samples, Diagnostic Test: Lower respiratory tract standard culture, Diagnostic Test: Blood sample standard culturePatients with suspected HAP or VAP in which lower tract respiratory samples are analyzed with standard culture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Pregnancy,
- Concomitant participating in other interventional trial
- Refusal to sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lower tract respiratory samplesWithin 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 | Procedure or surgery | Film-array Pneumonia Panel Plus group, Standard culture group (control group) |
| 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 | Film-array Pneumonia Panel Plus group |
| Lower respiratory tract standard cultureThe 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 | Film-array Pneumonia Panel Plus group, Standard culture group (control group) |
| Blood sample standard cultureWhen HAP or VAP are suspected, blood samples from peripheral vein will be collected and analyzed with conventional microbiological methods | Diagnostic test | Film-array Pneumonia Panel Plus group, Standard culture group (control group) |
Primary outcome
Proportion of patients without microbiological diagnosis of HAP/VAP within the first 24 hours
Time frame: 24 hours
Proportion of patients where a microbiological diagnosis of HAP/VAP is not avaiable within the first 24 hours
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gennaro De Pascale, MD principal investigator
Fondazione Policlinico A. Gemelli IRCCS
Massimo Antonelli, MD study chair
Fondazione Policlinico A. Gemelli IRCCS
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lower tract respiratory samples, Multiplex PCR assay (Film-array Pneumonia Panel Plus) and Lower respiratory tract standard culture in people with HAP - Hospital Acquired Pneumonia and VAP - Ventilator Associated Pneumonia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients without microbiological diagnosis of HAP/VAP within the first 24 hours (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.