Incidence of VAP in Patients With Severe COVID-19

NCT04766983 | Completed

• 1 other identifier: 20/01/2021-0002005-U
• Study Type: observational
• Target: 323
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator Associated Pneumonia; Covid19

Outcome Measures

Primary Outcomes (1)

• Incidence of VAP

  Incidence of clinically suspected and microbiologically confirmed VAP by means of BAL

  1,000 ventilator days

Secondary Outcomes (6)

• number of episodes with concordance in bacterial isolates between BAL and ETA performed on VAP suspicion

  1,000 ventilator days

• number of episodes with concordance in bacterial isolates between BAL performed on VAP suspicion and the preceding surveillance ETA

  1,000 ventilator days

• number of episodes with concordance in cellular phenotype between BAL and peripheral blood on VAP suspicion

  1,000 ventilator days

• number of episodes with concordance in lymphocyte-monocyte activation between BAL and peripheral blood on VAP suspicion

  1,000 ventilator days

• number of episodes with concordance in SARS-CoV-2 viral quantification between BAL, ETA and nasopharyngeal swab on VAP suspicion

  1,000 ventilator days

Study Arms (3)

VAP - BAL positive

Clinically suspected VAP, microbiologically confirmed by BAL

Diagnostic Test: bronchoalveolar lavage

VAP - BAL negative

Clinically suspected VAP, not microbiologically confirmed by BAL

Diagnostic Test: bronchoalveolar lavage

NO VAP

No clinically suspected VAP during mechanical ventilation

Interventions

bronchoalveolar lavage DIAGNOSTIC_TEST

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

VAP - BAL negative; VAP - BAL positive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Mechanically ventilated patients with severe SARS-CoV-2 infection

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation

Milan, MI, 20122, Italy

Location

Related Publications (7)

• 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.

  PMID: 32091533 BACKGROUND

• 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.

  PMID: 32167538 BACKGROUND

• 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.

  PMID: 27742143 BACKGROUND

• 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.

  PMID: 32157357 BACKGROUND

• 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.

  PMID: 27521441 BACKGROUND

• 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.

  PMID: 28890434 BACKGROUND

• 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.

  PMID: 37749631 DERIVED

Related Links

• COVID-19 cases worldwide

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal swab, Bronchial aspirate, bronchoalveolar lavage

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; COVID-19

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 23, 2021
• Study Start: February 28, 2020
• Primary Completion: May 31, 2022
• Study Completion: January 31, 2023
• Last Updated: March 7, 2023

Record last verified: 2023-03

Locations

IT (1)