Procalcitonin-guided Antibiotic Therapy During Severe Exacerbation of COPD

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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Exacerbation Copd
• Intervention / Treatment: Diagnostic test: procalcitonin

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tunisia
  • Mahdia, Tunisia, 5100
    • Recruiting
    • Tilouche Nejla
    • Contact: Nejla Tilouche, MD; Phone Number: 0021623277911; Email: tilouche.nejla@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: standard group; participants receive systematically empiric antibiotic therapy on admission with amoxicillin- acid clavulanic or levofloxacin in case of allergy
ACTIVE_COMPARATOR: Procalcitonin group; participants receive antibiotics only if the procalcitonin value is at or greater than 0.25 ng/ml	Diagnostic test: procalcitonin; 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

What is the study measuring?

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
ICU mortality		28 days
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

Collaborators and Investigators

• Sponsor: University Hospital, Mahdia

Publications and helpful links

General Publications

• Mathioudakis AG, Chatzimavridou-Grigoriadou V, Corlateanu A, Vestbo J. Procalcitonin to guide antibiotic administration in COPD exacerbations: a meta-analysis. Eur Respir Rev. 2017 Jan 31;26(143):160073. doi: 10.1183/16000617.0073-2016. Print 2017 Jan.
• Christ-Crain M, Jaccard-Stolz D, Bingisser R, Gencay MM, Huber PR, Tamm M, Muller B. Effect of procalcitonin-guided treatment on antibiotic use and outcome in lower respiratory tract infections: cluster-randomised, single-blinded intervention trial. Lancet. 2004 Feb 21;363(9409):600-7. doi: 10.1016/S0140-6736(04)15591-8.
• Schuetz P, Christ-Crain M, Thomann R, Falconnier C, Wolbers M, Widmer I, Neidert S, Fricker T, Blum C, Schild U, Regez K, Schoenenberger R, Henzen C, Bregenzer T, Hoess C, Krause M, Bucher HC, Zimmerli W, Mueller B; ProHOSP Study Group. Effect of procalcitonin-based guidelines vs standard guidelines on antibiotic use in lower respiratory tract infections: the ProHOSP randomized controlled trial. JAMA. 2009 Sep 9;302(10):1059-66. doi: 10.1001/jama.2009.1297.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 5, 2017
• Primary Completion (ANTICIPATED): October 1, 2020
• Study Completion (ANTICIPATED): December 31, 2020

Study Registration Dates

• First Submitted: February 6, 2018
• First Submitted That Met QC Criteria: February 13, 2018
• First Posted (ACTUAL): February 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 13, 2019
• Last Update Submitted That Met QC Criteria: May 10, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: mechanical ventilation; procalcitonin; COPD exacerbation
• Other Study ID Numbers: 301401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No