Ventilator Associated PneumoniaCoV-APNCT04766983
Incidence of VAP in Patients With Severe COVID-19
An observational study of Ventilator Associated Pneumonia and Covid19, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
Combined retrospective and prospective cohort study to evaluate the incidence of microbiologically confirmed VAP in mechanically ventilated patients with COVID-19. In the retrospective part, microbiological data are based on bi-weekly surveillance ETA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia, Covid19
- What is being tested?
- bronchoalveolar lavage
- How many people
- 323 participants
- Where
- 1 siteItaly
- Study dates
- 28 Feb 2020to 31 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: Mechanically ventilated patients with severe SARS-CoV-2 infection
Who may be able to join
- Age ≥ 18 years
- Diagnosis of SARS-CoV-2 infection by means of reverse transcription polymerase chain reaction (RT-PCR)
- Respiratory failure requiring mechanical ventilation
- mechanical ventilation ongoing for less than 48h
Who cannot join
- Age < 18 years
- mechanical ventilation ongoing for more than 48h
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation
Milan, MI, 20122
About this study
Official title: Cohort Study to Evaluate the Incidence of Ventilator-associated Pneumonia by Means of Bronchoalveolar Lavage in Patients With Severe SARS-CoV-2 Infection
Combined retrospective and prospective cohort study to evaluate the incidence of microbiologically confirmed VAP in mechanically ventilated patients with COVID-19. In the retrospective part, microbiological data are based on bi-weekly surveillance ETA. In the prospective part, microbiological data are based on ETA and BAL performed on VAP suspicion. In the prospective part, immunological and virological analyses will be performed on biological samples (blood, respiratory tract) collected from patients at VAP diagnosis.
Read the detailed description
Ventilator-associated pneumoniae (VAP) is the most common infection acquired in the intensive care unit (ICU). To date, there is no diagnostic gold standard for VAP, and its diagnosis is based on scores that include radiologic, clinical, laboratory, and microbiologic parameters. In addition, there is no univocal recommendation regarding the type of microbiological diagnostics. Some guidelines suggest the use of noninvasive methods (endotracheal aspiration, ETA) with semiquantitative cultures, while others suggest the collection of distal respiratory samples (bronchoalveolar lavage, BAL) with quantitative cultures. While the former method is characterized by higher sensitivity and lower specificity, the latter in contrast has higher specificity. To date, there is no evidence that one method is superior to the other in terms of clinical outcome.
In patients with severe SARS-CoV-2 infection, COVID-19 disease itself and immunomodulatory therapies have a direct impact on most of the clinical, laboratory and radiologic parameters required to achieve VAP diagnosis. In this setting, a diagnostic approach characterized by higher sensitivity coupled with lower specificity could lead to of a high number of false positives. The greatest risk is that of an overdiagnosis of VAP and a consequent overtreatment, with the related therapeutic toxicity and increased antibiotic resistance.
At the investigators' Hospital, the diagnosis of VAP is based on clinical-radiological suspicion according to the Johanson score (new finding or progression of infiltrates on lung radiography + at least two of the following three clinical criteria: fever > 38°C, leukocytosis or leukopenia, purulent secretions), widely validated in non-COVID patients. Until the end of 2020, microbiological data to confirm the diagnosis of clinically suspected VAP and to guide antibiotic therapy were based on the performance of biweekly surveillance ETA. In view of the limited specificity of this approach in COVID-19 setting, from the end of 2020 patients with SARS-CoV-2 infection and suspected VAP undergo, if clinically possible, to collection of distal respiratory specimens by performing BAL/mini-BAL.
The present prospective-retrospective cohort study aims to evaluate the incidence of microbiologically confirmed VAP with BAL (prospective part) and biweekly surveillance ETA (retrospective part) in mechanically ventilated patients with COVID-19 in the ICU. In the prospective part, immunological and virological analyses will be performed on biological samples (blood, respiratory tract) collected from patients at VAP diagnosis.
The study will last 12 months.
- Conditions
- Ventilator Associated Pneumonia, Covid19
- Being tested
- bronchoalveolar lavage
- Medical subject headings
- Pneumonia, Ventilator-Associated, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bronchoalveolar lavageDiagnostic test
BAL and ETA are performed as per clinical practice on clinical suspicion of VAP (Johanson score)
| Study group | Role | What they receive |
|---|---|---|
| VAP - BAL positive | Clinically suspected VAP, microbiologically confirmed by BAL Receives: Diagnostic Test: bronchoalveolar lavage | |
| VAP - BAL negative | Clinically suspected VAP, not microbiologically confirmed by BAL Receives: Diagnostic Test: bronchoalveolar lavage | |
| NO VAP | No clinically suspected VAP during mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of VAP
Incidence of clinically suspected and microbiologically confirmed VAP by means of BAL
Measured: 1,000 ventilator days
Secondary outcomes (6)
number of episodes with concordance in bacterial isolates between BAL and ETA performed on VAP suspicion
microbiological concordance of respiratory specimens collected by BAL and ETA on VAP suspicion
Measured: 1,000 ventilator days
number of episodes with concordance in bacterial isolates between BAL performed on VAP suspicion and the preceding surveillance ETA
microbiological concordance of respiratory specimens collected by BAL on VAP suspicion and the preceding bi-weekly surveillance ETA
Measured: 1,000 ventilator days
number of episodes with concordance in cellular phenotype between BAL and peripheral blood on VAP suspicion
immunological analysis of cellular phenotype in BAL and peripheral blood collected on VAP suspicion
Measured: 1,000 ventilator days
number of episodes with concordance in lymphocyte-monocyte activation between BAL and peripheral blood on VAP suspicion
immunological analysis of lymphocyte-monocyte activation in BAL and peripheral blood collected on VAP suspicion
Measured: 1,000 ventilator days
number of episodes with concordance in SARS-CoV-2 viral quantification between BAL, ETA and nasopharyngeal swab on VAP suspicion
virological analysis of SARS-CoV-2 viral quantification in BAL, ETA and nasopharyngeal swab collected on VAP suspicion (subgroup analysis)
Measured: 1,000 ventilator days
number of episodes with concordance in SARS-CoV-2 sequencing between BAL, ETA and nasopharyngeal swab on VAP suspicion
virological analysis of SARS-CoV-2 sequencing in BAL, ETA and nasopharyngeal swab collected on VAP suspicion (subgroup analysis)
Measured: 1,000 ventilator days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start28 Feb 2020
- Primary completion31 May 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe 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
- Other
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giacomo Grasselli, MD, Principal investigator, Intensive Care Unit, IRCCS Ca' Granda Ospedale Maggiore Policlinico FoundationAndrea Gori, MD, Principal investigator, Infectious Diseases Unit, IRCCS Ca' Granda Ospedale Maggiore Policlinico FoundationMauro Panigada, MD, Principal investigator, Intensive Care Unit, IRCCS Ca' Granda Ospedale Maggiore Policlinico FoundationAlessandra Bandera, MD, PhD, Principal investigator, Infectious Diseases Unit, IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766983
- Sponsor's protocol ID
- 20/01/2021-0002005-U
- Acronym
- CoV-AP
- Status last verified
- Mar 2023
- First submitted
- 27 Jan 2021
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymized data will be shared upon written request to the study director
Publications
Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
PubMed 32091533Grasselli G, Pesenti A, Cecconi M. Critical Care Utilization for the COVID-19 Outbreak in Lombardy, Italy: Early Experience and Forecast During an Emergency Response. JAMA. 2020 Apr 28;323(16):1545-1546. doi: 10.1001/jama.2020.4031. No abstract available.
PubMed 32167538Rosenthal VD, Al-Abdely HM, El-Kholy AA, AlKhawaja SAA, Leblebicioglu H, Mehta Y, Rai V, Hung NV, Kanj SS, Salama MF, Salgado-Yepez E, Elahi N, Morfin Otero R, Apisarnthanarak A, De Carvalho BM, Ider BE, Fisher D, Buenaflor MCSG, Petrov MM, Quesada-Mora AM, Zand F, Gurskis V, Anguseva T, Ikram A, Aguilar de Moros D, Duszynska W, Mejia N, Horhat FG, Belskiy V, Mioljevic V, Di Silvestre G, Furova K, Ramos-Ortiz GY, Gamar Elanbya MO, Satari HI, Gupta U, Dendane T, Raka L, Guanche-Garcell H, Hu B, Padgett D, Jayatilleke K, Ben Jaballah N, Apostolopoulou E, Prudencio Leon WE, Sepulveda-Chavez A, Telechea HM, Trotter A, Alvarez-Moreno C, Kushner-Davalos L; Remaining authors. International Nosocomial Infection Control Consortium report, data summary of 50 countries for 2010-2015: Device-associated module. Am J Infect Control. 2016 Dec 1;44(12):1495-1504. doi: 10.1016/j.ajic.2016.08.007. Epub 2016 Oct 11.
PubMed 27742143Papazian L, Klompas M, Luyt CE. Ventilator-associated pneumonia in adults: a narrative review. Intensive Care Med. 2020 May;46(5):888-906. doi: 10.1007/s00134-020-05980-0. Epub 2020 Mar 10.
PubMed 32157357Kalil AC, Metersky ML, Klompas M, Muscedere J, Sweeney DA, Palmer LB, Napolitano LM, O'Grady NP, Bartlett JG, Carratala J, El Solh AA, Ewig S, Fey PD, File TM Jr, Restrepo MI, Roberts JA, Waterer GW, Cruse P, Knight SL, Brozek JL. Executive Summary: Management of Adults With Hospital-acquired and Ventilator-associated Pneumonia: 2016 Clinical Practice Guidelines by the Infectious Diseases Society of America and the American Thoracic Society. Clin Infect Dis. 2016 Sep 1;63(5):575-82. doi: 10.1093/cid/ciw504.
PubMed 27521441Torres A, Niederman MS, Chastre J, Ewig S, Fernandez-Vandellos P, Hanberger H, Kollef M, Li Bassi G, Luna CM, Martin-Loeches I, Paiva JA, Read RC, Rigau D, Timsit JF, Welte T, Wunderink R. International ERS/ESICM/ESCMID/ALAT guidelines for the management of hospital-acquired pneumonia and ventilator-associated pneumonia: Guidelines for the management of hospital-acquired pneumonia (HAP)/ventilator-associated pneumonia (VAP) of the European Respiratory Society (ERS), European Society of Intensive Care Medicine (ESICM), European Society of Clinical Microbiology and Infectious Diseases (ESCMID) and Asociacion Latinoamericana del Torax (ALAT). Eur Respir J. 2017 Sep 10;50(3):1700582. doi: 10.1183/13993003.00582-2017. Print 2017 Sep.
PubMed 28890434Mangioni D, Panigada M, Palomba E, Bobbio C, Chatenoud L, Alagna L, Fumagalli J, Gori A, Grancini A, Guzzardella A, Lombardi A, Matinato C, Meli A, Muscatello A, Porretti L, Tomasello M, Trombetta E, Valenti L, Bandera A, Grasselli G. Incidence, microbiological and immunological characteristics of ventilator-associated pneumonia assessed by bronchoalveolar lavage and endotracheal aspirate in a prospective cohort of COVID-19 patients: CoV-AP study. Crit Care. 2023 Sep 26;27(1):369. doi: 10.1186/s13054-023-04658-5.
PubMed 37749631
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study to Evaluate the Incidence of Ventilator-associated Pneumonia by Means of Bronchoalveolar Lavage in Patients With Severe SARS-CoV-2 Infection
- ClinicalTrials.gov ID
- NCT04766983
- Acronym / sponsor ID
- CoV-AP / 20/01/2021-0002005-U
- Conditions
- Ventilator Associated Pneumonia, Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 23 Feb 2021 (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.
Combined retrospective and prospective cohort study to evaluate the incidence of microbiologically confirmed VAP in mechanically ventilated patients with COVID-19. In the retrospective part, microbiological data are based on bi-weekly surveillance ETA. In the prospective part, microbiological data are based on ETA and BAL performed on VAP suspicion. In the prospective part, immunological and virological analyses will be performed on biological samples (blood, respiratory tract) collected from patients at VAP diagnosis.
Detailed description
Ventilator-associated pneumoniae (VAP) is the most common infection acquired in the intensive care unit (ICU). To date, there is no diagnostic gold standard for VAP, and its diagnosis is based on scores that include radiologic, clinical, laboratory, and microbiologic parameters. In addition, there is no univocal recommendation regarding the type of microbiological diagnostics. Some guidelines suggest the use of noninvasive methods (endotracheal aspiration, ETA) with semiquantitative cultures, while others suggest the collection of distal respiratory samples (bronchoalveolar lavage, BAL) with quantitative cultures. While the former method is characterized by higher sensitivity and lower specificity, the latter in contrast has higher specificity. To date, there is no evidence that one method is superior to the other in terms of clinical outcome.
In patients with severe SARS-CoV-2 infection, COVID-19 disease itself and immunomodulatory therapies have a direct impact on most of the clinical, laboratory and radiologic parameters required to achieve VAP diagnosis. In this setting, a diagnostic approach characterized by higher sensitivity coupled with lower specificity could lead to of a high number of false positives. The greatest risk is that of an overdiagnosis of VAP and a consequent overtreatment, with the related therapeutic toxicity and increased antibiotic resistance.
At the investigators' Hospital, the diagnosis of VAP is based on clinical-radiological suspicion according to the Johanson score (new finding or progression of infiltrates on lung radiography + at least two of the following three clinical criteria: fever > 38°C, leukocytosis or leukopenia, purulent secretions), widely validated in non-COVID patients. Until the end of 2020, microbiological data to confirm the diagnosis of clinically suspected VAP and to guide antibiotic therapy were based on the performance of biweekly surveillance ETA. In view of the limited specificity of this approach in COVID-19 setting, from the end of 2020 patients with SARS-CoV-2 infection and suspected VAP undergo, if clinically possible, to collection of distal respiratory specimens by performing BAL/mini-BAL.
The present prospective-retrospective cohort study aims to evaluate the incidence of microbiologically confirmed VAP with BAL (prospective part) and biweekly surveillance ETA (retrospective part) in mechanically ventilated patients with COVID-19 in the ICU. In the prospective part, immunological and virological analyses will be performed on biological samples (blood, respiratory tract) collected from patients at VAP diagnosis.
The study will last 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VAP - BAL positive | – | Diagnostic Test: bronchoalveolar lavageClinically suspected VAP, microbiologically confirmed by BAL |
| VAP - BAL negative | – | Diagnostic Test: bronchoalveolar lavageClinically suspected VAP, not microbiologically confirmed by BAL |
| NO VAP | – | –No clinically suspected VAP during mechanical ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mechanically ventilated patients with severe SARS-CoV-2 infection
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Diagnosis of SARS-CoV-2 infection by means of reverse transcription polymerase chain reaction (RT-PCR)
- Respiratory failure requiring mechanical ventilation
- mechanical ventilation ongoing for less than 48h
Key exclusion criteria (2 listed)
- Age < 18 years
- mechanical ventilation ongoing for more than 48h
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 |
|---|---|---|
| bronchoalveolar lavageBAL and ETA are performed as per clinical practice on clinical suspicion of VAP (Johanson score) | Diagnostic test | VAP - BAL negative, VAP - BAL positive |
Primary outcome
Incidence of VAP
Time frame: 1,000 ventilator days
Incidence of clinically suspected and microbiologically confirmed VAP by means of BAL
6 secondary outcomes
number of episodes with concordance in bacterial isolates between BAL and ETA performed on VAP suspicion
Time frame: 1,000 ventilator days
number of episodes with concordance in bacterial isolates between BAL performed on VAP suspicion and the preceding surveillance ETA
Time frame: 1,000 ventilator days
number of episodes with concordance in cellular phenotype between BAL and peripheral blood on VAP suspicion
Time frame: 1,000 ventilator days
number of episodes with concordance in lymphocyte-monocyte activation between BAL and peripheral blood on VAP suspicion
Time frame: 1,000 ventilator days
number of episodes with concordance in SARS-CoV-2 viral quantification between BAL, ETA and nasopharyngeal swab on VAP suspicion
Time frame: 1,000 ventilator days
number of episodes with concordance in SARS-CoV-2 sequencing between BAL, ETA and nasopharyngeal swab on VAP suspicion
Time frame: 1,000 ventilator 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 7 Mar 2023.
- Background: PubMed 32091533Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
- Background: PubMed 32167538Grasselli G, Pesenti A, Cecconi M. Critical Care Utilization for the COVID-19 Outbreak in Lombardy, Italy: Early Experience and Forecast During an Emergency Response. JAMA. 2020 Apr 28;323(16):1545-1546. doi: 10.1001/jama.2020.4031. No abstract available.
- Background: PubMed 27742143Rosenthal VD, Al-Abdely HM, El-Kholy AA, AlKhawaja SAA, Leblebicioglu H, Mehta Y, Rai V, Hung NV, Kanj SS, Salama MF, Salgado-Yepez E, Elahi N, Morfin Otero R, Apisarnthanarak A, De Carvalho BM, Ider BE, Fisher D, Buenaflor MCSG, Petrov MM, Quesada-Mora AM, Zand F, Gurskis V, Anguseva T, Ikram A, Aguilar de Moros D, Duszynska W, Mejia N, Horhat FG, Belskiy V, Mioljevic V, Di Silvestre G, Furova K, Ramos-Ortiz GY, Gamar Elanbya MO, Satari HI, Gupta U, Dendane T, Raka L, Guanche-Garcell H, Hu B, Padgett D, Jayatilleke K, Ben Jaballah N, Apostolopoulou E, Prudencio Leon WE, Sepulveda-Chavez A, Telechea HM, Trotter A, Alvarez-Moreno C, Kushner-Davalos L; Remaining authors. International Nosocomial Infection Control Consortium report, data summary of 50 countries for 2010-2015: Device-associated module. Am J Infect Control. 2016 Dec 1;44(12):1495-1504. doi: 10.1016/j.ajic.2016.08.007. Epub 2016 Oct 11.
- Background: PubMed 32157357Papazian L, Klompas M, Luyt CE. Ventilator-associated pneumonia in adults: a narrative review. Intensive Care Med. 2020 May;46(5):888-906. doi: 10.1007/s00134-020-05980-0. Epub 2020 Mar 10.
- Background: PubMed 27521441Kalil AC, Metersky ML, Klompas M, Muscedere J, Sweeney DA, Palmer LB, Napolitano LM, O'Grady NP, Bartlett JG, Carratala J, El Solh AA, Ewig S, Fey PD, File TM Jr, Restrepo MI, Roberts JA, Waterer GW, Cruse P, Knight SL, Brozek JL. Executive Summary: Management of Adults With Hospital-acquired and Ventilator-associated Pneumonia: 2016 Clinical Practice Guidelines by the Infectious Diseases Society of America and the American Thoracic Society. Clin Infect Dis. 2016 Sep 1;63(5):575-82. doi: 10.1093/cid/ciw504.
- Background: PubMed 28890434Torres A, Niederman MS, Chastre J, Ewig S, Fernandez-Vandellos P, Hanberger H, Kollef M, Li Bassi G, Luna CM, Martin-Loeches I, Paiva JA, Read RC, Rigau D, Timsit JF, Welte T, Wunderink R. International ERS/ESICM/ESCMID/ALAT guidelines for the management of hospital-acquired pneumonia and ventilator-associated pneumonia: Guidelines for the management of hospital-acquired pneumonia (HAP)/ventilator-associated pneumonia (VAP) of the European Respiratory Society (ERS), European Society of Intensive Care Medicine (ESICM), European Society of Clinical Microbiology and Infectious Diseases (ESCMID) and Asociacion Latinoamericana del Torax (ALAT). Eur Respir J. 2017 Sep 10;50(3):1700582. doi: 10.1183/13993003.00582-2017. Print 2017 Sep.
- Derived from this study: PubMed 37749631Mangioni D, Panigada M, Palomba E, Bobbio C, Chatenoud L, Alagna L, Fumagalli J, Gori A, Grancini A, Guzzardella A, Lombardi A, Matinato C, Meli A, Muscatello A, Porretti L, Tomasello M, Trombetta E, Valenti L, Bandera A, Grasselli G. Incidence, microbiological and immunological characteristics of ventilator-associated pneumonia assessed by bronchoalveolar lavage and endotracheal aspirate in a prospective cohort of COVID-19 patients: CoV-AP study. Crit Care. 2023 Sep 26;27(1):369. doi: 10.1186/s13054-023-04658-5.
- COVID-19 cases worldwideLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Anonymized data will be shared upon written request to the study director
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.
Giacomo Grasselli, MD principal investigator
Intensive Care Unit, IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation
Andrea Gori, MD principal investigator
Infectious Diseases Unit, IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation
Mauro Panigada, MD principal investigator
Intensive Care Unit, IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation
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 Covid19, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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 4 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: finished, as of the sponsor's last update on 7 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 Italy. 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?
Incidence of VAP (time frame: 1,000 ventilator 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 NCT04766983, which also lists 7 linked publications.
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 7 Mar 2023.