TCTR20160726002
Completed
Phase 2
Procalcitonin-guided Discontinuation of Antibiotic in Ventilator-Associated Pneumonia
-0 sites50 target enrollmentJuly 26, 2016
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Ventilator Associated Pneumonia
- Sponsor
- -
- Enrollment
- 50
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Patients who were intubated and had received mechanical ventilation for at least 48 hours.
- •\-age \> 18 years
- •\- clinical suspicion of VAP as defined by the ATS guidelines (new or progress pulmonary infiltration on CXR with two or more of the following: new or progress of fever; purulent sputum; WBC \< 4,000 or \> 12,000 cell/mm3\); and simplified version of clinical pulmonary infection score \> 6\.
Exclusion Criteria
- •\- pregnant
- •\- enrolled in another trial
- •\- had little chance of survival
- •\- had neutropenia (leukocyte counts \<1000/µL or neutrophils \<500/µL)
- •\- had received immunosuppressants or long term corticosteroid therapy (≥ 0\.5 mg/kg/day of prednisolone or equivalent dose for \>1 month)
- •\- had concomitant acquired immunodeficiency syndrome
- •\- had a concomitant extrapulmonary infection diagnosed between days 1 and 3 that required prolonged (\>8 days) antibiotic treatment or infection caused by confirmed non\-bacterial pathogens such as fungus or virus.
- •\- not received appropriate antibiotic within 3 days after enrollment
- •\- had unfavorable clinical response after 7 days of appropriate antibiotic treatment as defined by one of the following: body temperature \>37\.8°C; shock or use of inotropes or vasopressors; clinical pulmonary infection score \>6\.
Outcomes
Primary Outcomes
Not specified
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