Procalcitonin for discontinuation of antibiotic therapy in clinically diagnosed Ventilator Associated Pneumonia
- Conditions
- Ventilator associated pneumoniaRespiratory
- Registration Number
- ISRCTN61015974
- Lead Sponsor
- niversity Hospital Basel (Switzerland)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
1. Intensive Care Unit (ICU) patients who are intubated and have been mechanically ventilated for at least 48 hours
2. 18 years of age and older
3. Clinical suspicion of VAP based on clinical and radiological criteria (new or progressive radiographic infiltrate) plus at least two of three clinical features:
3.1. fever greater than 38°C
3.2. leukocytosis or leucopenia
3.3. purulent tracheal secretions
1. Pregnancy
2. Patients with coexisting, documented extrapulmonary infection diagnosed between days one and three that requires antibiotic therapy longer than three days
3. Previous long-term corticosteroid therapy (more than or equal to 0.5 mg/kg per day of prednisolone or equivalent for more than one month)
4. Severe immunosuppression (solid organ transplantation or stem cell transplant recipients, known Human Immunodeficiency Virus [HIV] infection, neutropenic patients and patients after chemotherapy)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of antibiotic free-days (for VAP) alive within 28 days of clinically suspicion of VAP.
- Secondary Outcome Measures
Name Time Method 1. Clinical deterioration (defined as an increase in Clinical Pulmonary Infection Score [CPIS] of more than two points)<br>2. Microbiologically documented pulmonary infection recurrence<br>3. The evolution of signs and symptoms potentially linked to pulmonary infection (fever, leukocyte counts, partial pressure of oxygen in arterial blood [PaO2]/fraction of inspired oxygen [FiO2], and radiological infiltrates)<br>4. Number of mechanical ventilation-free days at 28 days<br>5. The length of stay in the ICU within 30 days<br>6. In-hospital mortality up to 30 days<br>7. Mortality at 30 days<br>8. Percentage of patients in the ProCT group for whom treatment recommendations are followed<br>9. Correlation of other biomarkers and clinical course