Combined Use of a Respiratory Multiplex PCR and Algorithm-based Therapy to Improve Early Optimization of Antibiotic Therapy in Critically Ill Patients With Ventilator-associated Pneumonia

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nīmes

About this trial

Assess the impact of a strategy combining respiratory mPCR and algorithm-based therapy developed using local epidemiology on the early optimization of initial antibiotic therapy for ventilator-associated pneumonia (VAP) (intervention), compared to a conventional strategy (control).

A bicentric, parallel-group, randomized controlled trial. The primary assessment criterion is the proportion of early optimized antibiotic therapy within 24 hours of respiratory sampling.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults (≥18 years) with VAP (mechanical ventilation and hospitalization ≥ 48 hours) and deep respiratory sample by mini BAL < 12 hours. The diagnosis of pneumonia includes two clinical criteria among fever (≥38.3°C), purulent sputum or aspiration, hyperleukocytosis (>12,000 WBC/mm³) or leukopenia (<4,000 WBC/mm³), hypoxemia, auscultatory signs in the affected area, and a newly-appeared parenchymal infiltrate

Patient receiving initial probabilistic antibiotic therapy for VAP suspicion

Informed consent or emergency procedure

Patient affiliated with or beneficiary of a health insurance plan.

Disqualifiers

mPCR non available

Trial design

Design model

Parallel

Treatments tested in this trial

  • strategy combining respiratory mPCR and algorithm-based therapy developed using local epidemiology

    Procedure/Surgery

    strategy combining respiratory mPCR carried out either by mini bronchoalveolar lavage (BAL) via bronchoscopy or by blind mini BAL, and algorithm-based therapy developed using local epidemiology for the early optimization of initial antibiotic therapy

Treatment groups

124 Participants
are divided into 2 treatment groups
Group A: combined use of mPCR and algorithm-based therapyExperimental treatment 1 intervention
Group B: Conventional strategy for antibiotic therapy at discretion of ICU physiciansNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

The effectiveness of a combined use a broad panel respiratory mPCR and an algorithm-based therapy developed using local epidemiology on the early optimization of initial antibiotic therapy for VAP, as compared to a conventional strategy

Proportion of patients receiving optimized antibiotic therapy defined as effective antibiotic therapy and for which antibiotic de-escalation, when recommended, was performed early, within 24 hours after deep respiratory sampling.

Time frame
Day 1

Secondary outcomes

1

Duration of exposure to broad-spectrum antibiotic therapy.

Average number of days of broad-spectrum antibiotic administration per patient at day 28

Time frame
Day 28
2

Compare expected and actual time frames for optimizing antibiotic therapy in the two arms.

Time in hours between deep respiratory sampling and optimization of antibiotic therapy.

Time frame
day 28
3

Quantify early antibiotic de-escalation in the two groups under study

Early and broad-spectrum antibiotic sparing according to the modified Antibiotic Spectrum Index (ASIm) de-escalation score (from No antibiotics (0) to very broad (≥8))

Time frame
day 1 and day 7
4

Rate of Clinical Cure at Day

use test of cure at day 7

Time frame
day 7

Other outcomes

Sponsors and contacts

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