NCT03348579

Brief Summary

hospital-acquired pneumonia are a common disease in intensive care unit. The prevention, the diagnosis and the treatment of hospital acquired pneumonia are a frequent challenge. Nevertheless it seems that there are great differences in standard of care between hospitals. The investigators hypothesized that medical education and implementation of evidence-base guidelines can reduce the duration of mechanical ventilation in patients presenting of hospital acquired pneumonia

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,850

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2018

Completed
Last Updated

May 12, 2020

Status Verified

November 1, 2017

Enrollment Period

1.1 years

First QC Date

November 16, 2017

Last Update Submit

May 8, 2020

Conditions

Keywords

Intensive care unitPneumoniaVentilator associatedHospital acquired pneumoniaGuidelines

Outcome Measures

Primary Outcomes (1)

  • Unit length of stay

    Duration of ICU hospitalization Safety Issue: NA

    28 days

Secondary Outcomes (4)

  • Intensive Care Unit free-days at day 28

    28 days

  • Hospital-acquired pneumonia

    28 days

  • Composite measure of compliance to guidelines

    28 days

  • Empirical treatment failure

    28 days

Study Arms (3)

The before period

The before period (control phase) will consist of all consecutive patients admitted to the participating ICUs before the national guidelines publication concerning hospital-acquired pneumonia.

Other: Guidelines publication and application

The second period

Intensive care units are randomized in two groups: Standard training: The centers will receive the text of the recommendation electronically. The principal investigator of each center will then train doctors, interns, nurses and physiotherapists to the use of these recommendations (team leader). A computer presentation common to all the centers will be used and a communication strategy vis-à-vis the other caregivers of the investigative services will be put in place. All doctors, interns and nurses must have attended this theoretical training during the awareness phase.

Other: Guidelines publication and applicationOther: Targeted experience feedback

The third and final period

The third and final period will consist of all consecutive patients admitted to the participating ICUs after the formal training.

Other: Guidelines publication and application

Interventions

Passing recommendations on using the guidelines in the intensive care units

The before periodThe second periodThe third and final period

Targeted experience feedback": On top of the standard training, the centers receive an analysis of the evolution of the practices of their center and the future of their patients between phases 1 and 2, as well as these same values for the data set. The centers are then called to conduct a meeting to determine their priority improvement points based on this audi

The second period

Eligibility Criteria

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

adult patients hospitalized in intensive care units with a hospital stay greater than 72 hours and a GIs-II greater than or equal to 15.

You may qualify if:

  • Age \> 18 years ; IGS-II score \> 15 ; Hospital stay \>= 3 days

You may not qualify if:

  • Community-acquired pneumonia, pregnant women, refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de NANTES

Nantes, 44093, France

Location

Related Publications (1)

  • Roquilly A, Chanques G, Lasocki S, Foucrier A, Fermier B, De Courson H, Carrie C, Danguy des Deserts M, Gakuba C, Constantin JM, Lagarde K, Holleville M, Blidi S, Sossou A, Cailliez P, Monard C, Oudotte A, Mathieu C, Bourenne J, Isetta C, Perrigault PF, Lakhal K, Rouhani A, Asehnoune K, Guerci P, Tran Dinh A, Chousterman B, Cupaciu A, Dahyot-Fizelier C, Bellier R, Au Duong J, Mansour A, Morel J, Beauplet G, Vibet MA, Feuillet F, Sebille V, Leone M. Implementation of French Recommendations for the Prevention and the Treatment of Hospital-acquired Pneumonia: A Cluster-randomized Trial. Clin Infect Dis. 2021 Oct 5;73(7):e1601-e1610. doi: 10.1093/cid/ciaa1441.

MeSH Terms

Conditions

Healthcare-Associated PneumoniaPneumonia, Ventilator-AssociatedSepsisPneumonia

Condition Hierarchy (Ancestors)

Cross InfectionInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSystemic Inflammatory Response SyndromeInflammation

Study Officials

  • Antoine Roquilly, PH

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR
  • Marc Leone

    AP-HM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
28 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2017

First Posted

November 21, 2017

Study Start

September 15, 2017

Primary Completion

October 15, 2018

Study Completion

December 15, 2018

Last Updated

May 12, 2020

Record last verified: 2017-11

Locations