Procalcitonin-guided Antibiotic Therapy During Severe Exacerbation of COPD

Acute Exacerbation Copd Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03440060
• Other study ID #: 301401
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2019
• Source: University Hospital, Mahdia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Exacerbation Copd

Intervention

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

Locations

Country	Name	City	State
Tunisia	Tilouche Nejla	Mahdia

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Mahdia

Country where clinical trial is conducted

Tunisia, 

References & Publications (3)

Christ-Crain M, Jaccard-Stolz D, Bingisser R, Gencay MM, Huber PR, Tamm M, Müller B. Effect of procalcitonin-guided treatment on antibiotic use and outcome in lower respiratory tract infections: cluster-randomised, single-blinded intervention trial. Lance — View 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). pii: 160073. doi: 10.1183/16000617.0073-2016. Print 2017 Jan. Review. — View 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 procalci — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	NIV failure	clinical deterioration requiring invasive ventilation or death	28 days
Secondary	ICU length of say (days)	number of days spent in the ICU during the index exacerbation	90 days
Secondary	Hospital length of stay (days)	number of days spent in hospital during the index exacerbation	90 days
Secondary	ICU mortality		28 days