ClinicalTrials.gg
CompletedNCT03348579PNEUMOCAREUpdated May 12, 2020

Hospital-acquired Pneumonia in Intensive Care Unit

An observational study in Hospital Acquired Pneumonia, Ventilator-Associated Pneumonia and Sepsis, sponsored by Nantes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-12.

Primary conditionPneumonia, Ventilator-AssociatedRegistry: Healthcare-Associated PneumoniaReclassifiedWhy we changed it
Registry
Healthcare-Associated Pneumonia — the first condition term the registry derived for this study.
ClinicalTrials.gg
Pneumonia, Ventilator-Associated
Why
  1. The study's listed conditions name Pneumonia, Ventilator-Associated, a narrower term within Healthcare-Associated Pneumonia.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Nantes University Hospital · Observational

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Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,850
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 80 studies in Pneumonia, Ventilator-Associated with a site in France — 20 open to participants now, 22 under way, 3 of them phase 3. Pneumonia, Ventilator-Associated · France.

Enrollment
6th of 33
1,850 · median 268
Started
2017
with 7 others
Observational
33 of 80
9 open now
Registered
38th of 80
by date
Lead sponsor
3 of 80
Nantes University Hospital

Among the 80 studies in Pneumonia, Ventilator-Associated with a site in France, this one is the 6th largest by enrollment of the 33 observational ones that give a count, is one of 8 that started in 2017, is one of 33 observational ones, and was the 38th registered.

Pneumonia, Ventilator-Associated

420 studies on the registry are indexed under Pneumonia, Ventilator-Associated; 83 are open to participants now.

Browse Pneumonia, Ventilator-Associated studies →

Open to participants now

20 of the 80 studies in Pneumonia, Ventilator-Associated with a site in France are open now. Recruiting first, the newest first:

15 more — sign in →

All 20 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 47 Pneumonia, Ventilator-Associated studies recruiting now, 36 (77%) set no upper age limit and 6 (13%) stop at 75 or younger; 6 take children under 18; 4 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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

Read the detailed description

The before period (phase 1) will consist of all consecutive patients admitted to the participating ICUs before the national guidelines publication concerning healthcare associated pneumonia.

The second period (phase 2) will consist of all consecutive patients admitted to the participating ICUs after the publication of the national guidelines publication concerning healthcare associated pneumonia.

Afterward, an interphase will occur during which all physicians, residents, physiotherapists and nurses will receive a formal training for the processes and procedures related to the new guidelines published in september 2017.

In the intervention group, 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 audit.

The third and final period (phase 3) will consist of all consecutive patients admitted to the participating ICUs after the formal training.

03

Conditions studied

  • Hospital Acquired Pneumonia
  • Ventilator-Associated Pneumonia
  • Sepsis
  • Pneumonia

Keywords

  • Intensive care unit
  • Pneumonia
  • Ventilator associated
  • Hospital acquired pneumonia
  • Guidelines
04

In context

Pneumonia, Ventilator-Associated Reclassified

420 studies on the registry are indexed under Pneumonia, Ventilator-Associated; 83 are open to participants now.

This study's enrollment of 1,850 is above the median of 170 across 132 observational studies indexed under Pneumonia, Ventilator-Associated.

Browse Pneumonia, Ventilator-Associated studies →

Lead sponsor

Nantes University Hospital is the lead sponsor of 839 studies on the registry; 191 are open to participants now.

Compared within Pneumonia, Ventilator-Associated, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Healthcare-Associated Pneumonia. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Community-acquired pneumonia, pregnant women, refusal to participate
06

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,850 participants (actual)
Target follow-up
28 Days
Patient registry
Yes

Groups and cohorts

  • 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 application · Other: 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

  • OtherGuidelines publication and application

    Passing recommendations on using the guidelines in the intensive care units

  • OtherTargeted experience feedback

    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

07

What researchers measure

Primary outcomes

  1. Unit length of stay

    Duration of ICU hospitalization Safety Issue: NA

    Time frame: 28 days

Secondary outcomes

  1. Intensive Care Unit free-days at day 28

    The number of days from day 1 to day 28 on which a patient is alive outside of intensive care unit Safety Issue

    Time frame: 28 days

  2. Hospital-acquired pneumonia

    definition based on the appearance of a new infiltrate or changes in an existing infiltrate on chest X-ray associated with any two of the following clinical signs: body temperature \>38°C, leucocytosis \>12,000/ml or leukopenia \<4000/ml, and purulent pulmonary secretions that were associated with a positive quantitative or semi-quantitative bacteriological culture of a respiratory tract sample.

    Time frame: 28 days

  3. Composite measure of compliance to guidelines

    defined as the total number of performed eligible measures divided by the total number of measures for which each patient was eligible

    Time frame: 28 days

  4. Empirical treatment failure

    Defined as one or more pathogen involved in the pneumonia is not susceptible to the antibiotics used empirically

    Time frame: 28 days

08

Study locations

1 site
  • CHU de NANTES
    Nantes, 44093, France
09

References and documents

Publications

  • 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. PubMed 32970811 ↗
10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2017 to primary completion in Oct 2018, 13 months.

Of 63 non-industry observational studies under Pneumonia, Ventilator-Associated, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 38. This study's 13 months is below that.

Counting every sponsor, half of 63 studies reached it within 20 months; a quarter within 12 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 16, 2017
First posted
Nov 21, 2017
StartActual
Sep 15, 2017
Primary completionActual
Oct 15, 2018
CompletionActual
Dec 15, 2018
Last update
May 12, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03348579
Collaborators
Société Française d'Anesthésie et de Réanimation
Responsible party
Sponsor
First posted
Nov 21, 2017
Start date
Sep 15, 2017
Primary completion
Oct 15, 2018
Completion
Dec 15, 2018
Last update
May 12, 2020

Study contacts

Antoine Roquilly, PH
principal investigator · Nantes University Hospital
Marc Leone
principal investigator · AP-HM

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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