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

• ClinicalTrials.gov Identifier: NCT03763799
• Recruitment Status: Recruiting
• First Posted: December 4, 2018
• Last Update Posted: November 20, 2020
• Sponsor: University Hospital, Lille
• Information provided by (Responsible Party): University Hospital, Lille

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.

Condition or disease	Intervention/treatment	Phase
Aspiration Pneumonia	Procedure: PCR-based microbiological diagnosis strategy; Procedure: Standard microbiological diagnosis strategy	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 266 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: September 20, 2019
• Estimated Primary Completion Date: September 2021
• Estimated Study Completion Date: September 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: multiplex PCR strategy; FilmArray® Pneumonia Panel plus	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
Active Comparator: standard strategy	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

Outcome Measures

Primary Outcome Measures :

1. 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 Measures :

1. the percentage of patients who will receive appropriate antibiotic treatment. [ Time Frame: at Day 28 and Day 90 after antibiotic treatment initiation ]
2. the percentage of patients who will receive targeted antibiotic treatment. [ Time Frame: at Day 28 and Day 90 after antibiotic treatment initiation ]
3. mechanical ventilation free days. [ Time Frame: at Day 28 and Day 90 after antibiotic treatment initiation ]
4. length of ICU stay. [ Time Frame: up to Day 90 ]
5. ICU mortality. [ Time Frame: up to Day 90 ]
6. antibiotic free days. [ Time Frame: up to Day 90 ]
7. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Contacts

Contact: Saadalla NSEIR, MD,PhD; 03 20 44 44 95 ext +33; Saadalla.NSEIR@chru-lille.fr

Locations

France

Chu Amiens Picardie; Recruiting

Amiens, France

Hôpital Roger Salengro, CHU; Recruiting

Lille, France

Contact: Saad Nseir 33320444495 s-nseir@chru-lille.fr

Principal Investigator: Saad Nseir, MD,PhD

Sponsors and Collaborators

University Hospital, Lille

Investigators

• Principal Investigator: Saadalla NSEIR, MD,PhD; University Hospital, Lille

More Information

• Responsible Party: University Hospital, Lille
• ClinicalTrials.gov Identifier: NCT03763799
• Other Study ID Numbers: 2018_40; 2018-A02219-46 ( Other Identifier: ID-RCB number, ANSM )
• First Posted: December 4, 2018
• Last Update Posted: November 20, 2020
• Last Verified: November 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Lille:

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

Additional relevant MeSH terms:

Pneumonia; Pneumonia, Aspiration; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases