Procalcitonin-guided Antibiotic Therapy During Severe Exacerbation of COPD

Sponsor

University Hospital, Mahdia (Other)

Overall Status

Unknown status

CT.gov ID

NCT03440060

Collaborator

(none)

100

Enrollment

Location

Arms

38.9

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Exacerbation Copd	Diagnostic Test: procalcitonin	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 5, 2017

Anticipated Primary Completion Date :

Oct 1, 2020

Anticipated Study Completion Date :

Dec 31, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

time to recovery [28 days]
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

Secondary Outcome Measures

Antibiotic exposure at day 90 [90 days]
number of days the patient received antibiotics for any infection within 90 days from the day of admission
Hospital readmission for another exacerbation at day 90 [90 days]
another readmission for another episode of COPD exacerbation within 90 days after a first discharge
NIV failure [28 days]
clinical deterioration requiring invasive ventilation or death
ICU length of say (days) [90 days]
number of days spent in the ICU during the index exacerbation
Hospital length of stay (days) [90 days]
number of days spent in hospital during the index exacerbation
ICU mortality [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tilouche Nejla	Mahdia		Tunisia	5100

Sponsors and Collaborators

University Hospital, Mahdia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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). pii: 160073. doi: 10.1183/16000617.0073-2016. Print 2017 Jan. Review.

Responsible Party:

Nejla Tilouche, principal investigator, University Hospital, Mahdia

ClinicalTrials.gov Identifier:

NCT03440060

Other Study ID Numbers:

301401

First Posted:

Feb 20, 2018

Last Update Posted:

May 13, 2019

Last Verified:

May 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nejla Tilouche, principal investigator, University Hospital, Mahdia

procalcitonin

mechanical ventilation

COPD exacerbation

Study Results

No Results Posted as of May 13, 2019