RecruitingNot ApplicableNCT05952648

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

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

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

126 participants

Start Date

Apr 3, 2024

Study Type

INTERVENTIONAL

Conditions

VAP - Ventilator Associated Pneumonia HAP - Hospital Acquired Pneumonia

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Blood sample standard culture, Lower respiratory tract standard culture, and others for people with hap - hospital acquired pneumonia and vap - ventilator associated pneumonia. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURELower 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_TESTMultiplex PCR assay (Film-array Pneumonia Panel Plus)

The lower tract respiratory samples will be analyzed with Multiplex PCR assay (Film-array Pneumonia Plus).

DIAGNOSTIC_TESTLower 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_TESTBlood sample standard culture

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