Procalcitonin-guided Antibiotic Therapy During Severe Exacerbation of COPD Requiring Mechanical Ventilation: a Controlled Randomized Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Exacerbation Copd
- Sponsor
- University Hospital, Mahdia
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- time to recovery
- Last Updated
- 6 years ago
Overview
Brief Summary
This study assess whether a procalcitonin guided antibiotic therapy can reduce significantly unnecessary antibiotic prescription during severe exacerbation of COPD requiring mechanical ventilation without compromising patients' outcome. The first group of patients will receive systematically empiric antibiotic therapy and the second group will receive antibiotics only if procalcitonin value is at or greater than 0.25 ng/ml.
Detailed Description
Recently, procalcitonin gained interest as the most reliable biomarker in predicting bacterial origin in low respiratory tract infections and sepsis. Procalcitonin was shown to be non-inferior to standard guidelines in guiding antibiotic therapy during COPD exacerbation, without worsening patients' outcomes, and with a significant reduction in antibiotic exposure. Its use to guide antibiotic treatment during COPD exacerbation may be more challenging because of the frequent colonization of the airways in patients with COPD, and thus it needs further evaluation. Additionally, until today, no interventional studies evaluating procalcitonin protocol have been conducted in ventilated COPD patients.
Investigators
Nejla Tilouche
principal investigator
University Hospital, Mahdia
Eligibility Criteria
Inclusion Criteria
- •Patients \> 40 years old who consent to the study protocol
- •COPD diagnosis based on GOLD guidelines
Exclusion Criteria
- •Patients who did not consent
- •Malignancy
- •Immunocompromised
- •Survival for at least 1 year is unlikely
- •Patients already enrolled in this study
Outcomes
Primary Outcomes
time to recovery
Time Frame: 28 days
defined by resolution of symptoms ( cough, sputum purulence and respiratory rate less than 25 breath per minute) and NIV withdrawal (normal pH for 24 consecutive hours after stopping NIV), for patients with home NIV investigators retain stabilization after returning to the same number of hours of NIV before current exacerbation and pH normalization for 24 consecutive hours
Secondary Outcomes
- NIV failure(28 days)
- ICU length of say (days)(90 days)
- ICU mortality(28 days)
- Antibiotic exposure at day 90(90 days)
- Hospital readmission for another exacerbation at day 90(90 days)
- Hospital length of stay (days)(90 days)