Procalcitonin-guided Antibiotic Therapy During Severe Exacerbation of COPD

University Hospital, Mahdia

Status: Unknown

Conditions: Acute Exacerbation Copd

Treatments: Diagnostic Test: procalcitonin

Study type: Interventional

Funder types: Other

Identifiers

NCT03440060

301401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

standard group

No Intervention group

Description:

participants receive systematically empiric antibiotic therapy on admission with amoxicillin- acid clavulanic or levofloxacin in case of allergy

Procalcitonin group

Active Comparator group

Description:

participants receive antibiotics only if the procalcitonin value is at or greater than 0.25 ng/ml

Treatment:

Diagnostic Test: procalcitonin