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

Primary Purpose

Aspiration Pneumonia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PCR-based microbiological diagnosis strategy
Standard microbiological diagnosis strategy
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aspiration Pneumonia focused on measuring Aspiration pneumonia, Invasive ventilation, PCR, Antibiotics, Tracheal aspirate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Chu Amiens PicardieRecruiting
  • Hôpital Roger Salengro, CHURecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

multiplex PCR strategy

standard strategy

Arm Description

FilmArray® Pneumonia Panel plus

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

the percentage of patients who will receive appropriate antibiotic treatment.
the percentage of patients who will receive targeted antibiotic treatment.
mechanical ventilation free days.
length of ICU stay.
ICU mortality.
antibiotic free days.
percentage of patients with colonization or infection related to multidrug-resistant bacteria (MDR)

Full Information

First Posted
December 3, 2018
Last Updated
December 15, 2022
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT03763799
Brief Title
Early Stop(Ruling) of the Antibiotic Treatment During Pneumopathies d' Inhalation
Acronym
APAPI
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2019 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aspiration Pneumonia
Keywords
Aspiration pneumonia, Invasive ventilation, PCR, Antibiotics, Tracheal aspirate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
266 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
multiplex PCR strategy
Arm Type
Experimental
Arm Description
FilmArray® Pneumonia Panel plus
Arm Title
standard strategy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
PCR-based microbiological diagnosis strategy
Intervention Description
A multiplex PCR-based testing, will be used in addition to standard microbiological culture of the tracheal aspirate to diagnose bacterial pneumonia after inhalation
Intervention Type
Procedure
Intervention Name(s)
Standard microbiological diagnosis strategy
Intervention Description
Standard strategy will be based on with standard microbiological culture of the tracheal aspirate to diagnose bacterial pneumonia after inhalation
Primary Outcome Measure Information:
Title
The percentage of patients who will benefit from an early stop of the probabilist antibiotic treatment
Time Frame
48 hours after antibiotic treatment initiation
Secondary Outcome Measure Information:
Title
the percentage of patients who will receive appropriate antibiotic treatment.
Time Frame
at Day 28 and Day 90 after antibiotic treatment initiation
Title
the percentage of patients who will receive targeted antibiotic treatment.
Time Frame
at Day 28 and Day 90 after antibiotic treatment initiation
Title
mechanical ventilation free days.
Time Frame
at Day 28 and Day 90 after antibiotic treatment initiation
Title
length of ICU stay.
Time Frame
up to Day 90
Title
ICU mortality.
Time Frame
up to Day 90
Title
antibiotic free days.
Time Frame
up to Day 90
Title
percentage of patients with colonization or infection related to multidrug-resistant bacteria (MDR)
Time Frame
at Day 28 and Day 90 after antibiotic treatment initiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Saadalla NSEIR, MD,PhD
Phone
03 20 44 44 95
Ext
+33
Email
Saadalla.NSEIR@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saadalla NSEIR, MD,PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Amiens Picardie
City
Amiens
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Roger Salengro, CHU
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saad Nseir
Phone
33320444495
Email
s-nseir@chru-lille.fr
First Name & Middle Initial & Last Name & Degree
Saad Nseir, MD,PhD

12. IPD Sharing Statement

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

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