Procalcitonin-guided Antibiotic Therapy During Severe Exacerbation of COPD

Study Overview
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Brief Summary
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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
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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.

Official Title
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Procalcitonin-guided Antibiotic Therapy During Severe Exacerbation of COPD Requiring Mechanical Ventilation: a Controlled Randomized Trial

Conditions
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Acute Exacerbation Copd

Intervention / Treatment
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* Diagnostic Test: procalcitonin


Participation Criteria
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Eligibility Criteria
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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 Asthma Malignancy Immunocompromised Survival for at least 1 year is unlikely Patients already enrolled in this study

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: standard group<br>participants receive systematically empiric antibiotic therapy on admission with amoxicillin- acid clavulanic or levofloxacin in case of allergy | |
| Active Comparator: Procalcitonin group<br>participants receive antibiotics only if the procalcitonin value is at or greater than 0.25 ng/ml | Diagnostic Test: procalcitonin<br>* procalcitonin value will be obtained within 24 hours after ICU admission in both groups and will be taken into account in the procalcitonin group only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to recovery | 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 | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibiotic exposure at day 90 | number of days the patient received antibiotics for any infection within 90 days from the day of admission | 90 days | 
| Hospital readmission for another exacerbation at day 90 | another readmission for another episode of COPD exacerbation within 90 days after a first discharge | 90 days | 
| NIV failure | clinical deterioration requiring invasive ventilation or death | 28 days | 
| ICU length of say (days) | number of days spent in the ICU during the index exacerbation | 90 days | 
| Hospital length of stay (days) | number of days spent in hospital during the index exacerbation | 90 days | 
| ICU mortality |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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procalcitonin, mechanical ventilation, COPD exacerbation