Incidence of VAP in Patients With Severe COVID-19

NCT ID: NCT04766983

Last Updated: 2023-03-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 323 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-28
• Study Completion Date: 2023-01-31

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

VAP - BAL positive

Clinically suspected VAP, microbiologically confirmed by BAL

bronchoalveolar lavage

Intervention Type: DIAGNOSTIC_TEST

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

bronchoalveolar lavage

Intervention Type: DIAGNOSTIC_TEST

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

No interventions assigned to this group

Interventions

bronchoalveolar lavage

BAL and ETA are performed as per clinical practice on clinical suspicion of VAP (Johanson score)

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giacomo Grasselli, MD

Role: PRINCIPAL_INVESTIGATOR

Intensive Care Unit, IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation

Andrea Gori, MD

Role: PRINCIPAL_INVESTIGATOR

Infectious Diseases Unit, IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation

Mauro Panigada, MD

Role: PRINCIPAL_INVESTIGATOR

Intensive Care Unit, IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation

Alessandra Bandera, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Infectious Diseases Unit, IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation

Locations

IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation

Milan, MI, Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 32091533 (View on PubMed)

Grasselli 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.

Reference Type: BACKGROUND

PMID: 32167538 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27742143 (View on PubMed)

Papazian 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.

Reference Type: BACKGROUND

PMID: 32157357 (View on PubMed)

Kalil 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.

Reference Type: BACKGROUND

PMID: 27521441 (View on PubMed)

Torres 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.

Reference Type: BACKGROUND

PMID: 28890434 (View on PubMed)

Mangioni 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.

Reference Type: DERIVED

PMID: 37749631 (View on PubMed)

Related Links

http://systems.jhu.edu

COVID-19 cases worldwide

Other Identifiers

20/01/2021-0002005-U

Identifier Type: -

Identifier Source: org_study_id