Procalcitonin-guided Antibiotic Therapy During Severe Exacerbation of COPD

Last updated: May 10, 2019
Sponsor: University Hospital, Mahdia
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03440060
301401
  • Ages > 40
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients > 40 years old who consent to the study protocol

  • COPD diagnosis based on GOLD guidelines

Exclusion

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

Total Participants: 100
Study Start date:
October 05, 2017
Estimated Completion Date:
December 31, 2020

Study 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.

Connect with a study center

  • Tilouche Nejla

    Mahdia, 5100
    Tunisia

    Active - Recruiting

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