Ventilator Associated PneumoniaNCT04372576
Epidemiology and Outcome of Ventilator-associated Pneumonia Among Critically Ill COVID-19 Patients
An observational study of Ventilator Associated Pneumonia and Corona Virus Infection, run by Semmelweis University at 1 site in Hungary.
Trial summary
The aim of this study is to determine the risk factors for development of ventilator-associated pneumonia (VAP) and to identify the prognostic factors of VAP among Coronavirus Disease 2019 (CoViD-19) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia, Corona Virus Infection
- What is being tested?
- Assessment of ventilator-associated pneumonia criteria
- How many people
- 30 participants
- Where
- 1 siteHungary
- Study dates
- 16 Apr 2020to Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill individuals diagnosed with PCR confirmed CoViD-19 disease requiring mechanical ventilation for > 48 hours.
Who may be able to join
- Critically ill individuals diagnosed with PCR confirmed CoViD-19 disease
- Started mechanical ventilation for > 48 hours
- Informed consent signed by the patient or authorised representative
Who cannot join
- Participation in an interventional trial aiming nosocomial infections
- refused informed consent
Trial locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
Semmelweis University
Budapest, 1085
Bence Mogyoródi, MD, +36208250801, mogyorodi.bence@med.semmelweis-univ.hu
About this study
The aim of this study is to determine the risk factors for development of ventilator-associated pneumonia (VAP) and to identify the prognostic factors of VAP among Coronavirus Disease 2019 (CoViD-19) patients. We hypothesized that CoViD-19 serves as a high risk factor for the development of VAP and it affects clinical outcome measures negatively.
Read the detailed description
Coronavirus Disease 2019 (CoViD-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) became a pandemic affecting thousands of individuals worldwide. A considerable proportion of CoViD-19 patients require admission to the intensive care unit (ICU), although limited data are available on their clinical characteristics and course. The results of retrospective studies indicate older age, presence of comorbidies and secondary infections as predictors of mortality among this population. Further evaluation regarding ICU clinical course and predictors of mortality is needed.
The aim of this study is to determine the risk factors for development of VAP and to identify the prognostic factors of VAP among CoViD-19 patients.
- Being tested
- Assessment of ventilator-associated pneumonia criteria
- Medical subject headings
- Pneumonia, Ventilator-Associated, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of ventilator-associated pneumonia criteriaDiagnostic test
Diagnosis of ventilator-associated pneumonia is based upon the routine daily clinical and laboratory parameters.
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day all-cause mortality
Measured: at study completion, anticipated 5 months
Secondary outcomes (4)
Days of mechanical ventilation
Measured: average time frame expected 2-3 weeks
ICU length-of-stay
Measured: average time frame expected 3-4 weeks
Antibiotic utilization
Measured: average time frame expected 3-4 weeks (at discharge from ICU)
Ventilator-associated pneumonia rate
Measured: at study completion, anticipated 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start16 Apr 2020
- Primary completionAug 2020 (estimated)
- Study completionAug 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 Semmelweis UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zsolt Iványi, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372576
- Sponsor's protocol ID
- 57/2020.
- Status last verified
- Apr 2020
- First submitted
- 29 Apr 2020
- Last updated
- 4 May 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 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology and Outcome of Ventilator-associated Pneumonia Among Critically Ill COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04372576
- Acronym / sponsor ID
- 57/2020.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 4 May 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.
The aim of this study is to determine the risk factors for development of ventilator-associated pneumonia (VAP) and to identify the prognostic factors of VAP among Coronavirus Disease 2019 (CoViD-19) patients. We hypothesized that CoViD-19 serves as a high risk factor for the development of VAP and it affects clinical outcome measures negatively.
Detailed description
Coronavirus Disease 2019 (CoViD-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) became a pandemic affecting thousands of individuals worldwide. A considerable proportion of CoViD-19 patients require admission to the intensive care unit (ICU), although limited data are available on their clinical characteristics and course. The results of retrospective studies indicate older age, presence of comorbidies and secondary infections as predictors of mortality among this population. Further evaluation regarding ICU clinical course and predictors of mortality is needed.
The aim of this study is to determine the risk factors for development of VAP and to identify the prognostic factors of VAP among CoViD-19 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill individuals diagnosed with PCR confirmed CoViD-19 disease requiring mechanical ventilation for > 48 hours.
Key inclusion criteria (3 listed)
- Critically ill individuals diagnosed with PCR confirmed CoViD-19 disease
- Started mechanical ventilation for > 48 hours
- Informed consent signed by the patient or authorised representative
Key exclusion criteria (2 listed)
- Participation in an interventional trial aiming nosocomial infections
- refused informed consent
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 |
|---|---|---|
| Assessment of ventilator-associated pneumonia criteriaDiagnosis of ventilator-associated pneumonia is based upon the routine daily clinical and laboratory parameters. | Diagnostic test | – |
Primary outcome
28-day all-cause mortality
Time frame: at study completion, anticipated 5 months
4 secondary outcomes
Days of mechanical ventilation
Time frame: average time frame expected 2-3 weeks
ICU length-of-stay
Time frame: average time frame expected 3-4 weeks
Antibiotic utilization
Time frame: average time frame expected 3-4 weeks (at discharge from ICU)
Ventilator-associated pneumonia rate
Time frame: at study completion, anticipated 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2020.
- Individual participant dataSharing planned: No
Related trials for Ventilator Associated Pneumonia
Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
Not yet recruitingObservational study
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Blood Stream Infections, Ventilator Associated Pneumonia
Not yet recruiting
Mobile-Based Microlearning for Improving ICU Nurses' Adherence to Ventilator-Associated Pneumonia Prevention Protocols
Ventilator-Associated Pneumonia
Not yet recruitingPhase 3
Cefepime-Zidebactam Versus Ceftazidime-Avibactam With or Without Colistin for Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia
Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Associated Bacterial Pneumonia (VABP)
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.
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 Corona Virus Infection, run by Semmelweis University at 1 site in Hungary.
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 3 inclusion and 2 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 4 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 Hungary. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day all-cause mortality (time frame: at study completion, anticipated 5 months). 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 4 May 2020.