Ventilator Associated PneumoniaNCT04344509
Microbial Etiology of Ventilator-associated Pneumonia in COVID-19 Infected Patients
An observational study of Ventilator Associated Pneumonia, run by Poitiers University Hospital.
Trial summary
National multicentric observational retrospective case-control study comparing the relative frequency of the various microorganisms responsible for VAP in patients infected or not by SARS-CoV-2 and their resistance to antibiotics. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- Bacterial species isolated
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- Jun 2020to Dec 2020
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with microbiologically confirmed VAP with pulmonary samples collected from March 15 to April 15 in France.
Who may be able to join
- All patients with microbiologically confirmed VAP with pulmonary samples collected from March 15 to April 15 in France.
Who cannot join
- All patients with microbiologically confirmed VAP with pulmonary samples collected from March 15 to April 15 in France.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Microbial Etiology of Ventilator-associated Pneumonia (VAP) in COVID-19 Infected Patients
National multicentric observational retrospective case-control study comparing the relative frequency of the various microorganisms responsible for VAP in patients infected or not by SARS-CoV-2 and their resistance to antibiotics.
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- Bacterial species isolated
- 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.
Bacterial species isolatedOther
in the respiratory specimen
| Study group | Role | What they receive |
|---|---|---|
| COVID19-positive patients | Not described Receives: Other: Bacterial species isolated | |
| COVID19-negative patients | Not described Receives: Other: Bacterial species isolated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of the microorganisms responsible for VAP among patients infected or not by the SARS-CoV-2
Measured: 1 month
Secondary outcomes (1)
Prevalence of multi-drug resistant bacteria responsible for VAP among patients infected or not by the SARS-CoV-2
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study startJun 2020 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionDec 2020 (estimated)
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 Poitiers 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
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344509
- Sponsor's protocol ID
- PAVM COVID
- Status last verified
- Apr 2020
- First submitted
- 10 Apr 2020
- Last updated
- 2 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbial Etiology of Ventilator-associated Pneumonia (VAP) in COVID-19 Infected Patients
- ClinicalTrials.gov ID
- NCT04344509
- Acronym / sponsor ID
- PAVM COVID
- Conditions
- Ventilator Associated Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Jun 2020 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 14 Apr 2020 (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.
National multicentric observational retrospective case-control study comparing the relative frequency of the various microorganisms responsible for VAP in patients infected or not by SARS-CoV-2 and their resistance to antibiotics.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID19-positive patients | – | Other: Bacterial species isolated |
| COVID19-negative patients | – | Other: Bacterial species isolated |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with microbiologically confirmed VAP with pulmonary samples collected from March 15 to April 15 in France.
Key inclusion criteria (1 listed)
- All patients with microbiologically confirmed VAP with pulmonary samples collected from March 15 to April 15 in France.
Key exclusion criteria (1 listed)
- All patients with microbiologically confirmed VAP with pulmonary samples collected from March 15 to April 15 in France.
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 |
|---|---|---|
| Bacterial species isolatedin the respiratory specimen | Other | COVID19-negative patients, COVID19-positive patients |
Primary outcome
Prevalence of the microorganisms responsible for VAP among patients infected or not by the SARS-CoV-2
Time frame: 1 month
1 secondary outcome
Prevalence of multi-drug resistant bacteria responsible for VAP among patients infected or not by the SARS-CoV-2
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator Associated Pneumonia, run by Poitiers University Hospital.
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: status not confirmed, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christophe BURUCOA (549443889 ext. +33, christophe.burucoa@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of the microorganisms responsible for VAP among patients infected or not by the SARS-CoV-2 (time frame: 1 month). 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 2 Jun 2020.