Clinical trial NCT03440060: Procalcitonin-guided Antibiotic Therapy During Severe Exacerbation of COPD
Official title: Procalcitonin-guided Antibiotic Therapy During Severe Exacerbation of COPD Requiring Mechanical Ventilation: a Controlled Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Exacerbation Copd
Keywords: procalcitonin
mechanical ventilation
COPD exacerbation
Lead sponsor: University Hospital, Mahdia
Sponsor class: OTHER
First posted: 2018-02-20
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: time to recovery
timeFrame: 28 days
Secondary outcomes:
measure: Antibiotic exposure at day 90
timeFrame: 90 days
measure: Hospital readmission for another exacerbation at day 90
timeFrame: 90 days
measure: NIV failure
timeFrame: 28 days
measure: ICU length of say (days)
timeFrame: 90 days
measure: Hospital length of stay (days)
timeFrame: 90 days
measure: ICU mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: Mahdia
country: Tunisia
facility: Tilouche Nejla
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.