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

Aspiration Pneumonia Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03763799
• Other study ID #: 2018_40
• Secondary ID: 2018-A02219-46
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2019
• Est. completion date: March 2025

Study information

• Verified date: December 2022
• Source: University Hospital, Lille
• Contact: Saadalla NSEIR, MD,PhD
• Phone: 03 20 44 44 95
• Email: Saadalla.NSEIR[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 266
• Est. completion date: March 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Aspiration Pneumonia
• Pneumonia
• Pneumonia, Aspiration

Intervention

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

Locations

Country	Name	City	State
France	Chu Amiens Picardie	Amiens
France	Hôpital Roger Salengro, CHU	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of patients who will benefit from an early stop of the probabilist antibiotic treatment		48 hours after antibiotic treatment initiation
Secondary	the percentage of patients who will receive appropriate antibiotic treatment.		at Day 28 and Day 90 after antibiotic treatment initiation
Secondary	the percentage of patients who will receive targeted antibiotic treatment.		at Day 28 and Day 90 after antibiotic treatment initiation
Secondary	mechanical ventilation free days.		at Day 28 and Day 90 after antibiotic treatment initiation
Secondary	length of ICU stay.		up to Day 90
Secondary	ICU mortality.		up to Day 90
Secondary	antibiotic free days.		up to Day 90
Secondary	percentage of patients with colonization or infection related to multidrug-resistant bacteria (MDR)		at Day 28 and Day 90 after antibiotic treatment initiation