NCT03355885

Brief Summary

Early-onset pneumonia after out-of-hospital cardiac arrest is frequent. An association between early-onset pneumonia and an increase in morbidity has been reported in this population. The diagnosis of early-onset pneumonia inpatients with out-of-hospital cardiac arrest may be challenging as diagnosis criteria are unspecific in this setting. On the other hand some studies have reported an association between early antibiotics and better prognosis in patients with out-of-hospital cardiac arrest suggesting that early diagnosis and treatment of pneumonia would benefit to patients. Nonetheless, adminitration of antibiotics to any patients with out-of-hospital cardiac arrest would expose to antibiotic patients without infection and woould participate to increase in antibiotic resistance. Therefore, the PP-ACR study aims to evaluate the impact of a diagnosis algorithm including blinded sampling protected brushes on early-onset pneumonia treatment and patient prognosis after out-of-hospital cardiac arrest.

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
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

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 3, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 28, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

November 29, 2017

Status Verified

October 1, 2017

Enrollment Period

1.7 years

First QC Date

November 23, 2017

Last Update Submit

November 28, 2017

Conditions

Keywords

early onset pneumoniaout-of-hospital cardiac arrestprognosisantibiotic

Outcome Measures

Primary Outcomes (2)

  • delay between intensive care admission and antibiotic initiation

    first 5 days

  • delta respiratory SOFA score between Day 1 and day 3

    first 3 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients admitted for out-of-hospital cardiac arrest in intensive care who and treated with hypothermia

You may qualify if:

  • patients admitted for out-of-hospital cardiac arrest and treated with hypothermia

You may not qualify if:

  • age less than 18
  • consent withdrawal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

RECRUITING

Related Publications (1)

  • Lemee P, Chapalain X, Bailly P, Sparrow RL, Jean-Michel V, Prat G, Renault A, Tonnelier JM, Aubron C. PROACTIVE SCREENING ALGORITHM FOR EARLY-ONSET PNEUMONIA IN PATIENTS WITH OUT-OF-HOSPITAL CARDIAC ARREST: A BEFORE-AFTER IMPLEMENTATION STUDY. Shock. 2024 Jul 1;62(1):13-19. doi: 10.1097/SHK.0000000000002347. Epub 2024 Mar 25.

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular Diseases

Central Study Contacts

Cecile Aubron, MD,PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2017

First Posted

November 28, 2017

Study Start

October 3, 2016

Primary Completion

May 31, 2018

Study Completion

July 1, 2018

Last Updated

November 29, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations