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Procalcitonin for discontinuation of antibiotic therapy in clinically diagnosed Ventilator Associated Pneumonia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN61015974
Enrollment
100
Registered
2006-09-01
Start date
2006-07-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Ventilator associated pneumonia Respiratory Ventilator associated pneumonia

Interventions

In this study, all patients, irrespective of the randomisation group, will be treated with antibiotics for 72 hours. 1. In patients randomly assigned to the standard therapy group, antibiotics will b

Sponsors

University Hospital Basel (Switzerland)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

MeasureTime frame
Number of antibiotic free-days (for VAP) alive within 28 days of clinically suspicion of VAP.

Secondary

MeasureTime frame
1. Clinical deterioration (defined as an increase in Clinical Pulmonary Infection Score [CPIS] of more than two points) 2. Microbiologically documented pulmonary infection recurrence 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) 4. Number of mechanical ventilation-free days at 28 days 5. The length of stay in the ICU within 30 days 6. In-hospital mortality up to 30 days 7. Mortality at 30 days 8. Percentage of patients in the ProCT group for whom treatment recommendations are followed 9. Correlation of other biomarkers and clinical course

Countries

Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 28, 2026