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Ventilator Associated Pneumonia Multiplex PCR for Anti-Infective Regimens

ConditionVentilator Associated Pneumonia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCHU de Reims

About this trial

Ventilator-associated pneumonia (VAP) remains one of the main nosocomial infections acquired in the intensive care unit (ICU). VAP is pneumonia occurring 48 hours after intubation. Today, bronchoalveolar lavage (BAL) is used for microbiological diagnosis, with bacterial culture and antibiotic susceptibility results within 48 to 72 hours. Multiplex PCR can detect DNA of a number of bacteriae, as well as the presence of resistance genes. However, its clinical value in the ICU remains to be demonstrated. We think that the use of multiplex PCR with a panel adapted to the microbiology of VAP, could be an interesting method for clinicians in ICU.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients, hospitalized in intensive care unit

on mechanical ventilation for at least 48 hours

Suspected VAP

With an indication for bronchoalveolar lavage (BAL)

Disqualifiers

Patients under legal protection or without social security coverage

Pregnant women

Previous episode of VAP during the same hospitalization

Trial design

Design model

Parallel

Treatments tested in this trial

  • Multiplex PCR

    Device

    In the intervention group (Multiplex PCR performed and results communicated to the clinician), bronchoalveolar lavage will be examined directly after Gram staining by the laboratory, followed by quantitative culture. A multiplex PCR will be performed.

Treatment groups

265 Participants
are divided into 2 treatment groups
Group A: intervention groupExperimental treatment 1 intervention
Group B: control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The percentage of appropriate empirical antibiotic therapy in cases of culture-confirmed VAP, according to the diagnostic method used (multiplex PCR or not).

The appropriate antibiotic is one that is effective against the diagnosed pathogen and has the narrowest possible antibiotic spectrum.

Time frame
Day 14

Secondary outcomes

1

The percentage of effective antibiotic treatment for the identified germ in each group.

The effective antibiotic is one that is effective against the diagnosed pathogen.

Time frame
Day 14
2

Duration of inappropriate antibiotic therapy (in hours) in each group

An inappropriate antibiotic is one that is not active according to the in vitro antibiogram of the identified pathogen, or whose spectrum is too broad for the resistance profile of the identified pathogen.

Time frame
Day 14

Other outcomes

Sponsors and contacts

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CHU de Reims

Lead sponsor

Source ClinicalTrials.gov
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