Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05952648

HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Array

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

S. Orsola Research Hospital, Bologna, Italy

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lower tract respiratory samples

Procedure

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 culture

Diagnostic 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 culture

Diagnostic Test

When HAP or VAP are suspected, blood samples from peripheral vein will be collected and analyzed with conventional microbiological methods

Primary outcomes

  1. 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

Secondary outcomes

  1. Rate of antibiotic de-escalation as a consequence of microbiological results

    Time frame: 4 days

    Proportion of patients in which antibiotic therapy has been modified from broad-spectrum empirical to targeted, due to microbiological results

  2. Time to antibiotic de-escalation and optimal therapy

    Time frame: 4 days

    Period of time from empirical antibiotic therapy initiation to modification due to microbiological results

  3. Mechanical Ventilation free-days

    Time frame: 14 and 28 days

    Number of days from enrollment in which the patients is not mechanically ventilated

  4. Rate of MDR infection

    Time frame: 28 days

    Proportion of patients who suffered from infection caused by multidrug resistant germ

  5. Lenght of intensive care unit stay

    Time frame: 60 days

    Period of time from enrollment in which the patient is admitted to the intensive care unit

  6. Lenght of hospital stay

    Time frame: 60 days

    Period of time from enrollment in which the patient is admitted to the hospital

  7. In-Intensive care unit mortality

    Time frame: 28 days and 60 days

    All-cause mortality, assessed during ICU stay

  8. 28 days and 60 days mortality

    Time frame: 28 days and 60 days

    All-cause mortality

  9. SOFA score

    Time frame: 14 days

    Measured SOFA score after 2,3,7 and 14 days from enrollment

  10. Diagnostic concordance

    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

  11. Adverse event

    Time frame: 28 days

    Proportion of patients in which any adverse event is registered

  12. In-Hospital mortality

    Time frame: 28 days and 60 days

    All-cause mortality, assessed during Hospital stay

Study contacts

Contact information is provided by the study sponsor or research team.

Gennaro De Pascale, MD

CONTACT

[email protected]

+393208998173

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Collaborators

  • Catholic University of the Sacred Heart

Registry information

Official study title

HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Assay: A Multicenter Randomized Open-Label Trial. THE LIGHTNING STUDY

Acronym: LIGHTNING

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 19, 2023
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.