Ventilator Associated PneumoniaDELAVAPNCT05205525
Delayed Antibiotic Therapy in Non-severe Ventilator Acquired Pneumonia (VAP)
An observational study of Ventilator Associated Pneumonia and Critical Care, run by Nantes University Hospital at 1 site in France.
Trial summary
This retro-prospective monocentric observational study compare the impact of the implementation of a restrictive (delayed) versus aggressive (immediate) antibiotic strategy for Ventilator Acquired Pneumonia suspicion without severity symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia, Critical Care, Antibiotic Therapy
- What is being tested?
- Restrictive antibiotic strategy and Aggressive antibiotic strategy
- How many people
- 87 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jan 2022to 28 Jan 2023
- 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: patient under mechanical ventilation in intensive care with suspected ventilator acquired pneumonia
Who may be able to join
- Under mechanical ventilation from more than 48 hours
- Suspected for a ventilator acquired pneumonia, requiring a distal pulmonary bacterial sample
Who cannot join
- New or worsening shock requiring vasopressor
- New or worsening severe hypoxemia (PaO2/FiO2<150 in FiO2≥60% and peep 10)
- Patient under veno-veinous extracorporeal membrane oxygenation
- Neutropenia <1G/L or immunosuppressive treatment (including corticosteroids >6 months or >0.5mg/kg/j)
- Disease (endocarditis, spondylodyscitis, deep abcedation…) requiring prolonged antibiotic therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aggressive Versus Restrictive Initiation of Antimicrobial Treatment in Critically Ill Patients With Suspected Ventilator Acquired Pneumonia Without Severity : a Before and After Observational Study
This retro-prospective monocentric observational study compare the impact of the implementation of a restrictive (delayed) versus aggressive (immediate) antibiotic strategy for Ventilator Acquired Pneumonia suspicion without severity symptoms.
Read the detailed description
Ventilator acquired pneumonia (VAP) is the leading cause of nosocomial infection in intensive care patients, and has been associated with increased antibiotic consumption, increased morbidity and mortality. VAP diagnosis is difficult due to subjective or non-specific criteria. Delaying antibiotic treatment for VAP suspicion without severity symptoms raises question since the probability of VAP diagnosis, as well as the risk of delaying treatment, is very uncertain. It may nonetheless limit the environmental impact of antibiotic use which is a public health concern. We compared antibiotic sparing and patient outcome, before and after the implementation of a restrictive (delayed) antibiotic strategy versus an aggressive (immediate) antibiotic strategy in VAP suspicion without severity symptoms.
- Being tested
- Restrictive antibiotic strategy, Aggressive antibiotic strategy
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restrictive antibiotic strategyOther
Implementation of a restrictive (delayed) antibiotic strategy in Ventilator Acquired Pneumonia suspicion without severity symptoms.
Aggressive antibiotic strategyOther
Implementation of an aggressive (immediate) antibiotic strategy in Ventilator Acquired Pneumonia suspicion without severity symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Restrictive antibiotic strategy | Not described Receives: Other: Restrictive antibiotic strategy | |
| Aggressive (immediate) antibiotic strategy | Not described Receives: Other: Aggressive antibiotic strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
antibiotic-free days
antibiotic-free days until Day 28 of Intensive Care Units stay
Measured: 28 days
Secondary outcomes (4)
Mechanical ventilation free days
Mechanical ventilation free days during the first 28 days
Measured: 28 days
Intensive care unit stay length
Measured: 28 days
Intensive care unit mortality
Measured: 28 days
Hospitality mortality
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 posted25 Jan 2022
- Study start6 Jan 2022
- Primary completion28 Jan 2023
- Study completion28 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated 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-control
- Time perspective
- Other
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205525
- Sponsor's protocol ID
- MR_DELAVAP
- Acronym
- DELAVAP
- Status last verified
- Mar 2023
- First submitted
- 11 Jan 2022
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aggressive Versus Restrictive Initiation of Antimicrobial Treatment in Critically Ill Patients With Suspected Ventilator Acquired Pneumonia Without Severity : a Before and After Observational Study
- ClinicalTrials.gov ID
- NCT05205525
- Acronym / sponsor ID
- DELAVAP / MR_DELAVAP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 28 Jan 2023 (actual)
- Study completion
- 28 Jan 2023 (actual)
- First posted
- 25 Jan 2022 (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.
This retro-prospective monocentric observational study compare the impact of the implementation of a restrictive (delayed) versus aggressive (immediate) antibiotic strategy for Ventilator Acquired Pneumonia suspicion without severity symptoms.
Detailed description
Ventilator acquired pneumonia (VAP) is the leading cause of nosocomial infection in intensive care patients, and has been associated with increased antibiotic consumption, increased morbidity and mortality. VAP diagnosis is difficult due to subjective or non-specific criteria. Delaying antibiotic treatment for VAP suspicion without severity symptoms raises question since the probability of VAP diagnosis, as well as the risk of delaying treatment, is very uncertain. It may nonetheless limit the environmental impact of antibiotic use which is a public health concern. We compared antibiotic sparing and patient outcome, before and after the implementation of a restrictive (delayed) antibiotic strategy versus an aggressive (immediate) antibiotic strategy in VAP suspicion without severity symptoms.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restrictive antibiotic strategy | – | Other: Restrictive antibiotic strategy |
| Aggressive (immediate) antibiotic strategy | – | Other: Aggressive antibiotic strategy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient under mechanical ventilation in intensive care with suspected ventilator acquired pneumonia
Key inclusion criteria (2 listed)
- Under mechanical ventilation from more than 48 hours
- Suspected for a ventilator acquired pneumonia, requiring a distal pulmonary bacterial sample
Key exclusion criteria (5 listed)
- New or worsening shock requiring vasopressor
- New or worsening severe hypoxemia (PaO2/FiO2<150 in FiO2≥60% and peep 10)
- Patient under veno-veinous extracorporeal membrane oxygenation
- Neutropenia <1G/L or immunosuppressive treatment (including corticosteroids >6 months or >0.5mg/kg/j)
- Disease (endocarditis, spondylodyscitis, deep abcedation…) requiring prolonged antibiotic therapy
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 |
|---|---|---|
| Restrictive antibiotic strategyImplementation of a restrictive (delayed) antibiotic strategy in Ventilator Acquired Pneumonia suspicion without severity symptoms. | Other | Restrictive antibiotic strategy |
| Aggressive antibiotic strategyImplementation of an aggressive (immediate) antibiotic strategy in Ventilator Acquired Pneumonia suspicion without severity symptoms. | Other | Aggressive (immediate) antibiotic strategy |
Primary outcome
antibiotic-free days
Time frame: 28 days
antibiotic-free days until Day 28 of Intensive Care Units stay
4 secondary outcomes
Mechanical ventilation free days
Time frame: 28 days
Intensive care unit stay length
Time frame: 28 days
Intensive care unit mortality
Time frame: 28 days
Hospitality mortality
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 8 Mar 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ventilator Associated Pneumonia and Critical Care, 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 2 inclusion and 5 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 8 Mar 2023. 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?
antibiotic-free days (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Mar 2023.