APAPI: Early Stop(Ruling) of the Antibiotic Treatment During Pneumopathies d' Inhalation

Sponsor

University Hospital, Lille (Other)

Overall Status

Recruiting

CT.gov ID

NCT03763799

Collaborator

(none)

266

Enrollment

Locations

Arms

23.4

Anticipated Duration (Months)

133

Patients Per Site

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The two most common consequences resulting from aspiration are chemical pneumonitis and bacterial aspiration pneumonia. Both entities present with comparable clinical signs and symptoms. In the absence of a reliable clinical or biological marker to differentiate between these two conditions, most patients with suspected aspiration are treated empirically with antibiotics. De-escalation of initial antibiotic treatment is encouraged based on the results of microbiological results, usually performed before starting antimicrobial treatment. However, in most hospitals, 48-72h are required to obtain the results of microbiological cultures, and to de-escalate empirical large spectrum antibiotic treatment.

The use of the Unyvero®, a multiplex PCR-based testing system, for detection of respiratory bacterial pathogens would allow decreasing the percentage of patients with aspiration syndrome who will receive unappropriated antibiotic treatment at Day 3.

Condition or Disease	Intervention/Treatment	Phase
Aspiration Pneumonia	Procedure: PCR-based microbiological diagnosis strategy Procedure: Standard microbiological diagnosis strategy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

266 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Impact of a Strategy Based on the Unyvero® Testing System on Appropriate Antimicrobial Treatment in Patients With Suspected Aspiration Pneumonia Requiring Mechanical Ventilation : a Randomized Controlled Unblinded Trial

Actual Study Start Date :

Sep 20, 2019

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: multiplex PCR strategy FilmArray® Pneumonia Panel plus	Procedure: PCR-based microbiological diagnosis strategy A multiplex PCR-based testing, will be used in addition to standard microbiological culture of the tracheal aspirate to diagnose bacterial pneumonia after inhalation
Active Comparator: standard strategy	Procedure: Standard microbiological diagnosis strategy Standard strategy will be based on with standard microbiological culture of the tracheal aspirate to diagnose bacterial pneumonia after inhalation

Arm

Intervention/Treatment

Experimental: multiplex PCR strategy

FilmArray® Pneumonia Panel plus

Procedure: PCR-based microbiological diagnosis strategy

A multiplex PCR-based testing, will be used in addition to standard microbiological culture of the tracheal aspirate to diagnose bacterial pneumonia after inhalation

Active Comparator: standard strategy

Procedure: Standard microbiological diagnosis strategy

Standard strategy will be based on with standard microbiological culture of the tracheal aspirate to diagnose bacterial pneumonia after inhalation

Outcome Measures

Primary Outcome Measures

The percentage of patients who will benefit from an early stop of the probabilist antibiotic treatment [48 hours after antibiotic treatment initiation]

Secondary Outcome Measures

the percentage of patients who will receive appropriate antibiotic treatment. [at Day 28 and Day 90 after antibiotic treatment initiation]
the percentage of patients who will receive targeted antibiotic treatment. [at Day 28 and Day 90 after antibiotic treatment initiation]
mechanical ventilation free days. [at Day 28 and Day 90 after antibiotic treatment initiation]
length of ICU stay. [up to Day 90]
ICU mortality. [up to Day 90]
antibiotic free days. [up to Day 90]
percentage of patients with colonization or infection related to multidrug-resistant bacteria (MDR) [at Day 28 and Day 90 after antibiotic treatment initiation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

presence of risk factors for aspiration :
known or likely swallowing dysfunction,
altered consciousness,
cardiac arrest,
difficult intubation
witnessed aspiration
symptoms and signs suggestive of lower respiratory tract pathology
temperature ≥38.5°C or <36°C
leukocyte count ≥10 000/µL or <1500/µL
purulent sputum or tracheal aspirate.
new radiographic infiltrate on chest X-ray
tracheal intubation and mechanical ventilation since less than 48 hours

Exclusion Criteria:

pregnant women
refuse to participate to the study
no informed consent
documented bacteremia
septic shock
severe immunosuppression: leukocytes<1000/L or neutrophils<500/L, chemotherapy during the last 3 months, organ transplant with chronic immunosuppressors use, HIV (CD4<50), and chronic corticosteroid use (>0.5 mg/kg day for at least one month during the last three months).
moribund patients (SAPS II >90).