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

University Hospital, Lille

Status: Completed

Conditions: Aspiration Pneumonia

Treatments: Procedure: Standard microbiological diagnosis strategy; Procedure: PCR-based microbiological diagnosis strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT03763799

2018_40

2018-A02219-46 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 266 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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266 participants in 2 patient groups

multiplex PCR strategy

Experimental group

Description:

FilmArray® Pneumonia Panel plus

Treatment:

Procedure: PCR-based microbiological diagnosis strategy

standard strategy

Active Comparator group

Treatment:

Procedure: Standard microbiological diagnosis strategy