Ventilator-Associated Pneumonia (VAP)
Conditions
Interventions
In the Gram stain group, the results of Gram staining of endotracheal aspirate are used to guide the selection of antibiotics. The results of the Gram stains are categorised as Gram-positive cocci (GP
s judgement.
In the standard group, patients are administered the combination of an anti-pseudomonal agent and anti-MRSA agent according to IDSA/ATS guidelines. Specific antibiotic agents are select
Sponsors
Division of Trauma and Surgical Critical Care, Osaka General Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients undergoing mechanical ventilation in the ICU will be enroled in this study if they meet all the inclusion and none of the exclusion criteria. Patients will be included if they (1) are aged equal or more than 15 years; (2) have undergone mechanical ventilation for at least 48 hours; (3) are diagnosed as having VAP, which is defined by a modified clinical pulmonary infection score of 5 or more; and (4) or their representatives provide written, informed consent
Exclusion criteria
Exclusion criteria: Patients will be excluded if they (1) have an allergy to study medications; (2) are pregnant; (3) have already been discharged from the ICU; (4) are diagnosed as having heart failure or atelectasis; (5) have been administered antibiotics for more than 24 hours when they meet the inclusion criteria; (6) are declined to provide full life support; or (7) are judged as inappropriate at the discretion of the study physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical cure of VAP Cure is defined as completion of antibiotic therapy within 14 days, improvement or lack of progression of baseline radiographic findings at the end of therapy (EOT), and resolution of signs and symptoms of pneumonia at the follow-up/test of cure visit (FU/TOC). Failure is defined as administration of study medication for 15 days or more, progression of radiological signs of pneumonia at EOT, or relapsed pneumonia at FU/TOC. | — |
Secondary
| Measure | Time frame |
|---|---|
| Select of anti-pseudomonal agents as initial antibiotic therapies Select of anti-MRSA agents as initial antibiotic therapies Coverage of initial antibiotic therapies 28-day mortality 28-day ICU-free days 28-day ventilator-free days Need of continuous renal replacement therapy Duration of antibiotic therapy De-escalation or escalation Renal impairment Thrombocytopenia Clostridium difficile infection The other adverse events related to antibiotics Inflammation marker (CRP, PCT) Organ failure control (SOFA) | — |
Countries
Japan
Contacts
Public ContactJumpei Yoshimura
Osaka General Medical Center Division of Trauma and Surgical Critical Care
Outcome results
None listed