NCT03440060

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 20, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

May 13, 2019

Status Verified

May 1, 2019

Enrollment Period

3 years

First QC Date

February 6, 2018

Last Update Submit

May 10, 2019

Conditions

Acute Exacerbation Copd

Keywords

procalcitoninmechanical ventilationCOPD exacerbation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Antibiotic exposure at day 90

    90 days

  • Hospital readmission for another exacerbation at day 90

    90 days

  • NIV failure

    28 days

  • ICU length of say (days)

    90 days

  • Hospital length of stay (days)

    90 days

  • +1 more secondary outcomes

Study Arms (2)

standard group

NO INTERVENTION

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

Procalcitonin group

ACTIVE COMPARATOR

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

Diagnostic Test: procalcitonin

Interventions

procalcitoninDIAGNOSTIC_TEST

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

Procalcitonin group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients \> 40 years old who consent to the study protocol
  • COPD diagnosis based on GOLD guidelines

You may not qualify if:

  • Patients who did not consent
  • Asthma
  • Malignancy
  • Immunocompromised
  • Survival for at least 1 year is unlikely
  • Patients already enrolled in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tilouche Nejla

Mahdia, 5100, Tunisia

RECRUITING

Related Publications (3)

  • 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.

    PMID: 28143877BACKGROUND

  • 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.

    PMID: 14987884RESULT

  • 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.

    PMID: 19738090RESULT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 6, 2018

First Posted

February 20, 2018

Study Start

October 5, 2017

Primary Completion

October 1, 2020

Study Completion

December 31, 2020

Last Updated

May 13, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)