MedPath

Serum procalcitonin for ventilator-associated pneumonia

Phase 2
Completed
Conditions
Ventilator Associated Pneumonia
ventilator&#45
associated pneumonia&#44
pneumonia&#44
clinical pulmonary infection score&#44
procalcitonin&#44
antibiotic discontinuation&#44
nonfermentative gram&#45
negative bacilli
Registration Number
TCTR20160726002
Lead Sponsor
-
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
50
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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
umber of antibiotic&#45;free days alive assessed 28 days after enrollment From the day of enrollment (the day of diagnosis of VAP) to day 28 after enrollment 28 &#45; Total antibiotic exposure days,Number of antibiotic&#45;free days alive assessed 28 days after enrollment From the day of enrollment (the day of diagnosis of VAP) to day 28 after enrollment count,Number of antibiotic&#45;free days alive assessed 28 days after enrollment From the day of enrollment (the day of diagnosis of VAP) to day 28 after enrollment count,Number of antibiotic&#45;free days alive assessed 28 days after enrollment From the day of enrollment (the day of diagnosis of VAP) to day 28 after enrollment count
Secondary Outcome Measures
NameTimeMethod
relapse or superinfection rate&#44; From the day of enrollment (the day of diagnosis of VAP) to day 28 after enrollment Patients were considered to have recurrent pneumonia when at least 1 bacterial species was reported ,number of mechanical ventilation&#45;free days From the day of enrollment (the day of diagnosis of VAP) to day 28 after enrollment 28 &#45; number of days without mechanical ventilation
© Copyright 2025. All Rights Reserved by MedPath