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

NCT ID: NCT03763799

Last Updated: 2022-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

266 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-20

Study Completion Date

2025-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Aspiration Pneumonia

Keywords

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Aspiration pneumonia Invasive ventilation PCR Antibiotics Tracheal aspirate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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multiplex PCR strategy

FilmArray® Pneumonia Panel plus

Group Type EXPERIMENTAL

PCR-based microbiological diagnosis strategy

Intervention Type 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

standard strategy

Group Type ACTIVE_COMPARATOR

Standard microbiological diagnosis strategy

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Saadalla NSEIR, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Chu Amiens Picardie

Amiens, , France

Site Status RECRUITING

Hôpital Roger Salengro, CHU

Lille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Saadalla NSEIR, MD,PhD

Role: CONTACT

Phone: 03 20 44 44 95

Email: [email protected]

Facility Contacts

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Saad Nseir

Role: primary

Other Identifiers

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2018-A02219-46

Identifier Type: OTHER

Identifier Source: secondary_id

2018_40

Identifier Type: -

Identifier Source: org_study_id