Procalcitonin-guided Antibiotic Therapy During Severe Exacerbation of COPD

Not Applicable

• Conditions: Acute Exacerbation Copd
• Interventions: Diagnostic Test: procalcitonin

• Registration Number: NCT03440060
• Lead Sponsor: University Hospital, Mahdia

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.

Study Timeline

• Study Start: 2017-10-05
• Study First Submitted: 2018-02-06
• Study First Submitted QC: 2018-02-13
• Study First Posted: 2018-02-20
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-10
• Last Update Posted: 2019-05-13
• Primary Completion: 2020-10-01
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Procalcitonin group	procalcitonin	participants receive antibiotics only if the procalcitonin value is at or greater than 0.25 ng/ml

Primary Outcome Measures

Name	Time	Method
time to recovery	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 Outcome Measures

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

Trial Locations

Locations (1)

Tilouche Nejla; 🇹🇳 Mahdia, Tunisia