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

NCT03763799 | Completed

• 2 other identifiers: 2018_402018-A02219-46
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 2

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.

Conditions

Aspiration Pneumonia

Keywords

Aspiration pneumonia; Invasive ventilation; PCR; Antibiotics; Tracheal aspirate

Outcome Measures

Primary Outcomes (1)

• The percentage of patients who will benefit from an early stop of the probabilist antibiotic treatment

  48 hours after antibiotic treatment initiation

Secondary Outcomes (7)

• 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

Study Arms (2)

multiplex PCR strategy

EXPERIMENTAL

FilmArray® Pneumonia Panel plus

Procedure: PCR-based microbiological diagnosis strategy

standard strategy

ACTIVE COMPARATOR

Procedure: Standard microbiological diagnosis strategy

Interventions

PCR-based microbiological diagnosis strategy PROCEDURE

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

multiplex PCR strategy

Standard microbiological diagnosis strategy PROCEDURE

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

standard strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (2)

Chu Amiens Picardie

Amiens, France

Location

Hôpital Roger Salengro, CHU

Lille, France

Location

MeSH Terms

Conditions

Pneumonia, Aspiration

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Saadalla NSEIR, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 4, 2018
• Study Start: September 20, 2019
• Primary Completion: February 22, 2024
• Study Completion: February 22, 2024
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

FR (2)