Hospital Acquired PneumoniaPNEUMOCARENCT03348579
Hospital-acquired Pneumonia in Intensive Care Unit
An observational study of Hospital Acquired Pneumonia and Ventilator-Associated Pneumonia, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospital Acquired Pneumonia, Ventilator-Associated Pneumonia, Sepsis
- What is being tested?
- Guidelines publication and application and Targeted experience feedback
- How many people
- 1,850 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2017to 15 Dec 2018
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age > 18 years ; IGS-II score > 15 ; Hospital stay >= 3 days
Who cannot join
- Community-acquired pneumonia, pregnant women, refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hospital Acquired and Ventilator Associated Pneumonia : Impact of the New French Guidelines on Patients Care and Outcomes.
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.
- Being tested
- Guidelines publication and application, Targeted experience feedback
- Keywords
- Intensive care unit, Pneumonia, Ventilator associated, Hospital acquired pneumonia, Guidelines
- Medical subject headings
- Healthcare-Associated Pneumonia, Pneumonia, Ventilator-Associated, Sepsis, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guidelines publication and applicationOther
Passing recommendations on using the guidelines in the intensive care units
Targeted experience feedbackOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Guidelines publication and application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unit length of stay
Duration of ICU hospitalization Safety Issue: NA
Measured: 28 days
Secondary outcomes (4)
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
Measured: 28 days
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.
Measured: 28 days
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
Measured: 28 days
Empirical treatment failure
Defined as one or more pathogen involved in the pneumonia is not susceptible to the antibiotics used empirically
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start15 Sep 2017
- Primary completion15 Oct 2018
- Study completion15 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hospital Acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,850 participants (actual)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Société Française d'Anesthésie et de Réanimation
- Responsible party
- Sponsor
- Investigators
- Antoine Roquilly, PH, Principal investigator, Nantes University HospitalMarc Leone, Principal investigator, AP-HM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03348579
- Sponsor's protocol ID
- RC17_0434
- Acronym
- PNEUMOCARE
- Status last verified
- Nov 2017
- First submitted
- 16 Nov 2017
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospital Acquired and Ventilator Associated Pneumonia : Impact of the New French Guidelines on Patients Care and Outcomes.
- ClinicalTrials.gov ID
- NCT03348579
- Acronym / sponsor ID
- PNEUMOCARE / RC17_0434
- Keywords
- Intensive care unit, Pneumonia, Ventilator associated, Hospital acquired pneumonia, Guidelines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,850 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Société Française d'Anesthésie et de Réanimation
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 15 Dec 2018 (actual)
- First posted
- 21 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The before period | – | Other: Guidelines publication and applicationThe before period (control phase) will consist of all consecutive patients admitted to the participating ICUs before the national guidelines publication concerning hospital-acquired pneumonia. |
| The second period | – | Other: Guidelines publication and application, Other: Targeted experience feedbackIntensive 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. |
| The third and final period | – | Other: Guidelines publication and applicationThe third and final period will consist of all consecutive patients admitted to the participating ICUs after the formal training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Age > 18 years ; IGS-II score > 15 ; Hospital stay >= 3 days
Key exclusion criteria (1 listed)
- Community-acquired pneumonia, pregnant women, refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guidelines publication and applicationPassing recommendations on using the guidelines in the intensive care units | Other | The before period, The second period, The third and final period |
| Targeted experience feedbackTargeted 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 | Other | The second period |
Primary outcome
Unit length of stay
Time frame: 28 days
Duration of ICU hospitalization Safety Issue: NA
4 secondary outcomes
Intensive Care Unit free-days at day 28
Time frame: 28 days
Hospital-acquired pneumonia
Time frame: 28 days
Composite measure of compliance to guidelines
Time frame: 28 days
Empirical treatment failure
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Derived from this study: PubMed 32970811Roquilly 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine Roquilly, PH principal investigator
Nantes University Hospital
Marc Leone principal investigator
AP-HM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hospital Acquired Pneumonia and Ventilator-Associated Pneumonia, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unit length of stay (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03348579, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.