Clinical trial NCT03763799: Early Stop(Ruling) of the Antibiotic Treatment During Pneumopathies d' Inhalation
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aspiration Pneumonia
Keywords: Aspiration pneumonia
Invasive ventilation
PCR
Antibiotics
Tracheal aspirate
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2018-12-04
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: The percentage of patients who will benefit from an early stop of the probabilist antibiotic treatment
timeFrame: 48 hours after antibiotic treatment initiation
Secondary outcomes:
measure: the percentage of patients who will receive appropriate antibiotic treatment.
timeFrame: at Day 28 and Day 90 after antibiotic treatment initiation
measure: the percentage of patients who will receive targeted antibiotic treatment.
timeFrame: at Day 28 and Day 90 after antibiotic treatment initiation
measure: mechanical ventilation free days.
timeFrame: at Day 28 and Day 90 after antibiotic treatment initiation
measure: length of ICU stay.
timeFrame: up to Day 90
measure: ICU mortality.
timeFrame: up to Day 90
measure: antibiotic free days.
timeFrame: up to Day 90
measure: percentage of patients with colonization or infection related to multidrug-resistant bacteria (MDR)
timeFrame: at Day 28 and Day 90 after antibiotic treatment initiation
Other outcomes:
Locations:
city: Amiens
country: France
facility: Chu Amiens Picardie
city: Lille
country: France
facility: Hôpital Roger Salengro, CHU
Study officials:
affiliation: University Hospital, Lille
name: Saadalla NSEIR, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: