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

ConditionsHAP - Hospital Acquired PneumoniaVAP - Ventilator Associated Pneumonia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Pregnancy,

Concomitant participating in other interventional trial

Refusal to sign informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lower tract respiratory samples

    Procedure/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 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

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: Film-array Pneumonia Panel Plus groupExperimental treatment 4 interventions
Group B: Standard culture group (control group)Active comparator 3 interventions

Trial outcomes

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

Time frame
24 hours

Secondary outcomes

1

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

Time frame
4 days
2

Time to antibiotic de-escalation and optimal therapy

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

Time frame
4 days
3

Mechanical Ventilation free-days

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

Time frame
14 and 28 days
4

Rate of MDR infection

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

Time frame
28 days

Other outcomes

Sponsors and contacts

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Lead sponsor

Catholic University of the Sacred Heart

Collaborator

Source ClinicalTrials.gov
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