Pre-emptive targeted and optimized treatment of critical airway colonization to prevent Ventilator Associated Pneumonia: a randomized controlled study

• Conditions: Ventilator Associated Pneumonia; MedDRA version: 15.0Level: LLTClassification code 10047263Term: Ventilation pneumonitisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2012-002774-31-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-03
• Last Update Posted: 24 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Age =18 years
•Admission to hospital >48 hours prior to ICU admission or expected IVM >48 hours
•SAPS score <66 (i.e. high chance of survival)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

• pregnancy
•VAT or VAP at the time of enrolment (Annex 1)
•Participation in other VAT/VAP trials
•SDD ongoing

Study & Design

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