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

NCT05952648 | Recruiting

• 1 other identifier: 5768
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

HAP - Hospital Acquired Pneumonia; VAP - Ventilator Associated Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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

  24 hours

Secondary Outcomes (12)

• Rate of antibiotic de-escalation as a consequence of microbiological results

  4 days

• Time to antibiotic de-escalation and optimal therapy

  4 days

• Mechanical Ventilation free-days

  14 and 28 days

• Rate of MDR infection

  28 days

• Lenght of intensive care unit stay

  60 days

Study Arms (2)

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)

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

Procedure: Lower tract respiratory samples; Diagnostic Test: Lower respiratory tract standard culture; Diagnostic Test: Blood sample standard culture

Interventions

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

Film-array Pneumonia Panel Plus group; Standard culture group (control group)

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).

Film-array Pneumonia Panel Plus group

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)

Film-array Pneumonia Panel Plus group; Standard culture group (control group)

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

Film-array Pneumonia Panel Plus group; Standard culture group (control group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy,
• Concomitant participating in other interventional trial
• Refusal to sign informed consent

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead
• Catholic University of the Sacred Heart: collaborator

Study Sites (4)

S. Orsola Research Hospital

Bologna, Italy

NOT YET RECRUITING

Ospedale Careggi

Florence, Italy

NOT YET RECRUITING

Modena Policlinico

Modena, Italy

NOT YET RECRUITING

Fondazione Policlinico Universitario "A. GEMELLI" IRCCS

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Healthcare-Associated Pneumonia; Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gennaro De Pascale, MD

  Fondazione Policlinico A. Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

• Massimo Antonelli, MD

  Fondazione Policlinico A. Gemelli IRCCS

  STUDY CHAIR

Central Study Contacts

Gennaro De Pascale, MD

CONTACT

+393208998173; gennaro.depascale@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled, multicenter, open-label trial

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: July 19, 2023
• Study Start: April 3, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

IT (4)