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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002774-31-IT

Enrollment

300

Registered

2012-09-03

Start date

2012-08-22

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator Associated Pneumonia MedDRA version: 15.0 Level: LLT Classification code 10047263 Term: Ventilation pneumonitis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: ZYVOXID*1SACCA INF 2MG/ML Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: LINEZOLID Concentration unit: mg milligram(s) Concentration type: equal Concentration n

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age =18 years • Admission to hospital >48 hours prior to ICU admission or expected IVM >48 hours • SAPS score =65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: to assess whether targeted pre-emptive therapy (based on isolates obtained from quantitative screening for colonization of lower respiratory airways) reduces VAP (see Annex 1) occurrence when compared to standard management;Secondary Objective: •Incidence of VAP (in terms of n episodes/patient-IMV days) •Association between colonization and VAT and VAP (and between VAT and VAP) •Cut-off of quantitative colonization as predictor of VAT and VAP •Time-to-colonization •Time from colonization to VAT and VAP;Primary end point(s): Primary outcome measure will be development of VAP. Definition of VAT and VAP to the study purpose are reported in Annex 1. Diagnostic procedures will follow current clinical guidelines. At study exit, each patient (i.e. both VAP and lack of VAP) will be reviewed and confirmed by a panel of experts (infectious diseases consultant, intensivist, microbiologist, radiologist). For a random 20% of cases a second panel will review the diagnosis and concordance will be assessed.;Timepoint(s) of evaluation of this end point: 72 hours of treatment, 60 days of follow-up.	—

Measure

Time frame

Main Objective: to assess whether targeted pre-emptive therapy (based on isolates obtained from quantitative screening for colonization of lower respiratory airways) reduces VAP (see Annex 1) occurrence when compared to standard management;Secondary Objective: •Incidence of VAP (in terms of n episodes/patient-IMV days) •Association between colonization and VAT and VAP (and between VAT and VAP) •Cut-off of quantitative colonization as predictor of VAT and VAP •Time-to-colonization •Time from colonization to VAT and VAP;Primary end point(s): Primary outcome measure will be development of VAP. Definition of VAT and VAP to the study purpose are reported in Annex 1. Diagnostic procedures will follow current clinical guidelines. At study exit, each patient (i.e. both VAP and lack of VAP) will be reviewed and confirmed by a panel of experts (infectious diseases consultant, intensivist, microbiologist, radiologist). For a random 20% of cases a second panel will review the diagnosis and concordance will be assessed.;Timepoint(s) of evaluation of this end point: 72 hours of treatment, 60 days of follow-up.

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Secondary

Measure	Time frame
Secondary end point(s): Incidence of VAP (in terms of n episodes/patient-IMV days) • Association between colonization and VAT and VAP (and between VAT and VAP) • Cut-off of quantitative colonization as predictor of VAT and VAP • Time-to-colonization • Time from colonization to VAT and VAP;Timepoint(s) of evaluation of this end point: 72 hours of treatment, 60 days of follow-up.	—

Countries

Italy

Contacts

Public ContactU.O. Malattie Infettive, Prof.Viale

AOU di Bologna, Policlinico S.Orsola-Malpighi

pierluigi.viale@unibo.it051/6363353

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026