Antimicrobial Stewardship For Ventilator Associated Pneumonia in Intensive Care

Phase 1

• Conditions: ventilator associated neumonia in intensive care; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2021-002197-78-FR
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-18
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 590

Inclusion Criteria

Adult patient is =18 and
- Patient under MV
- Diagnosis of microbiologically confirmed of first episode of VAP
- Initial adequate empiric antibiotic therapy
-Written informed consent from the patient or a legal representative if appropriate. If absence of a legal representative the patient may be included in emergency procedure
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 590
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 590

Exclusion Criteria

Patient under selective decontamination of the digestive tract
- Concomitant extra-respiratory infection requiring antibiotic therapy at the moment of inclusion
- Inclusion in another interventional study concerning antimicrobial strategies
- Moribund (IGS II>80)
- Thoracic trauma with Abbreviated Injury Scale (AIS) thorax ? 3
- Severely immunocompromised patients (such as congenital immunodeficiency , neutropenia (<1leucocyte/ml or <0.5 neutrophil/ml) or acute hematologic malignancy or stem cell transplant, HIV infection with CD4 count below 200/mm3
- VAP due to: Pseudomonas aeruginosa, Carbapenem-resistant Acinetobacter spp, Carbapenem-resistant Enterobacteriaceae
- Bacterial VAP in a context of COVID-19 or other confirmed viral pneumonia
- No health insurance coverage

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified