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Incidence of VAP in Patients With Severe COVID-19 (CoV-AP)

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ClinicalTrials.gov Identifier: NCT04766983
Recruitment Status : Recruiting
First Posted : February 23, 2021
Last Update Posted : February 23, 2021
Sponsor:
Information provided by (Responsible Party):
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Brief 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. 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.

Condition or disease Intervention/treatment
Ventilator Associated Pneumonia Covid19 Diagnostic Test: bronchoalveolar lavage

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Other
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
Actual Study Start Date : January 22, 2021
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Group/Cohort Intervention/treatment
VAP - BAL positive
Clinically suspected VAP, microbiologically confirmed by BAL
Diagnostic Test: bronchoalveolar lavage
BAL and ETA are performed as per clinical practice on clinical suspicion of VAP (Johanson score)

VAP - BAL negative
Clinically suspected VAP, not microbiologically confirmed by BAL
Diagnostic Test: bronchoalveolar lavage
BAL and ETA are performed as per clinical practice on clinical suspicion of VAP (Johanson score)

NO VAP
No clinically suspected VAP during mechanical ventilation



Primary Outcome Measures :
  1. Incidence of VAP [ Time Frame: 1,000 ventilator days ]
    Incidence of clinically suspected and microbiologically confirmed VAP by means of BAL


Secondary Outcome Measures :
  1. number of episodes with concordance in bacterial isolates between BAL and ETA performed on VAP suspicion [ Time Frame: 1,000 ventilator days ]
    microbiological concordance of respiratory specimens collected by BAL and ETA on VAP suspicion

  2. 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 ]
    microbiological concordance of respiratory specimens collected by BAL on VAP suspicion and the preceding bi-weekly surveillance ETA

  3. number of episodes with concordance in cellular phenotype between BAL and peripheral blood on VAP suspicion [ Time Frame: 1,000 ventilator days ]
    immunological analysis of cellular phenotype in BAL and peripheral blood collected on VAP suspicion

  4. number of episodes with concordance in lymphocyte-monocyte activation between BAL and peripheral blood on VAP suspicion [ Time Frame: 1,000 ventilator days ]
    immunological analysis of lymphocyte-monocyte activation in BAL and peripheral blood collected on VAP suspicion

  5. 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 ]
    virological analysis of SARS-CoV-2 viral quantification in BAL, ETA and nasopharyngeal swab collected on VAP suspicion (subgroup analysis)

  6. 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 ]
    virological analysis of SARS-CoV-2 sequencing in BAL, ETA and nasopharyngeal swab collected on VAP suspicion (subgroup analysis)


Biospecimen Retention:   Samples With DNA
Nasopharyngeal swab, Bronchial aspirate, bronchoalveolar lavage


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Mechanically ventilated patients with severe SARS-CoV-2 infection
Criteria

Retrospective part all patients admitted to the ICU for COVID-19-related respiratory failure since the beginning of the pandemics will be included.

Prospective part

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Age < 18 years
  • mechanical ventilation ongoing for more than 48h

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04766983


Contacts
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Contact: Giacomo Grasselli, MD +39 02 5502.3285 giacomo.grasselli@unimi.it
Contact: Andrea Gori, MD +39 02 5503.4763-4762 andrea.gori@unimi.it

Locations
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Italy
IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation Recruiting
Milan, MI, Italy, 20122
Contact: Giacomo Grasselli, MD       giacomo.grasselli@unimi.it   
Contact: Andrea Gori, MD       andrea.gori@unimi.it   
Sponsors and Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Investigators
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Principal Investigator: Giacomo Grasselli, MD Intensive Care Unit, IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation
Principal Investigator: Andrea Gori, MD Infectious Diseases Unit, IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation
Principal Investigator: Mauro Panigada, MD Intensive Care Unit, IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation
Principal Investigator: Alessandra Bandera, MD, PhD Infectious Diseases Unit, IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation
Additional Information:
Publications:
Rosenthal 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.

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Responsible Party: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier: NCT04766983    
Other Study ID Numbers: 20/01/2021-0002005-U
First Posted: February 23, 2021    Key Record Dates
Last Update Posted: February 23, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Anonymized data will be shared upon written request to the study director

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia, Ventilator-Associated
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection