Impact of a Strategy Based on Bacterial DNA Detection to Optimize Antibiotics in Immunocompromised Patients With Hospital-acquired Pneumonia Requiring Mechanical Ventilation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Lille

About this trial

RESPIRE is a randomized, unblinded, controlled study to measure the impact of a strategy based on a PCR test on the adjustment of antimicrobial therapy in immunocompromised patients suspected with ventilator-associated or hospital-acquired pneumonia (VAP/HAP) requiring mechanical ventilation (MV) in Intensive Care Unit (ICU). The gold-standard microbiological diagnostic method for pneumonia in the ICU is based on culture identification and antimicrobial susceptibility testing. Results are obtained in several days after the initiation of empiric antimicrobial therapy, exposing patients to a potential inappropriate broad-spectrum antimicrobial treatment. We aim to measure the impact of a PCR-based strategy to improve the percentage of patients with VAP or HAP receiving targeted antimicrobial therapy 24 hours after diagnosis compared to standard care

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult immunocompromised patients hospitalized in ICU with suspected VAP or HAP requiring MV

Disqualifiers

No immunodeficiency Moribund patients (SAPS II > 90) Pregnant women Refuse to participate to the study

Trial design

Design model

Parallel

Treatments tested in this trial

  • PCR based strategy

    Other intervention

    Early adjustment of antimicrobial therapy according to the results of a multiplex PCR-based testing, used in addition to standard microbiological culture of the tracheal aspirate, in immunocompromised patients with suspected VAP or HAP requiring MV

  • Standard care

    Other intervention

    Broad-spectrum antimicrobial therapy adjustment after results of standard microbiological culture of the tracheal aspirate in immunocompromised patients with suspected VAP or HAP requiring MV

Treatment groups

31 Participants
are divided into 2 treatment groups
Group A: PCR groupExperimental treatment 1 intervention
Group B: Control groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Increase in percentage of patients with targeted antibiotics

To determine the impact of a PCR-based strategy on the increase in percentage of patients with targeted antibiotics regimen 24 hours after starting empiric antimicrobial therapy in the experimental group compared to standard care

Time frame
24 hours after the initiation of empiric antimicrobial therapy

Secondary outcomes

1

Percentage of patients receiving appropriate anticrobial treatment

To determine the impact of a PCR-based strategy on the percentage of patients receiving approriate antimicrobial treatment 24 hours after starting empiric antimicrobial therapy in the experimental group compared to standard care

Time frame
24 hours after the initiation of empiric antimicrobial therapy
2

Mechanical ventilation free days

To determine the impact of a PCR-based strategy on the amount of days alive and free from mechanical ventilation at day 28 after the initiation of empiric antimicrobial therapy in the experimental group compared to standard care

Time frame
28 days after the initiation of empiric antimicrobial therapy
3

ICU Length of stay

To determine the impact of a PCR-based strategy on the length of stay in the Intensive Care Unit in the experimental group compared to standard care

Time frame
Until 28 days after the initiation of empiric antimicrobial therapy
4

28 days mortality

To determine the impact of a PCR-based strategy on the mortality at Day 28 after the initiation of empiric antimicrobial therapy in the experimental group compared to standard care

Time frame
28 days after the initiation of empiric antimicrobial therapy

Other outcomes

Sponsors and contacts

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