Impact of COVID-19 Infection on the Incidence of Ventilator-acquired Infections

NCT ID: NCT04359693

Last Updated: 2020-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1576 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-22

Study Completion Date

2020-07-01

Brief Summary

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Observational cohort study aiming at comparing the incidence of ventilator-associated lower respiratory tract infections between COVID-19 patients and two control groups: one with influenza pneumonia and the other with no viral pneumonia.

Detailed Description

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COVAPID is a multicenter cohort study with two retrospective control groups. No intervention will be performed in included patients, only patient characteristics and data on VA-LRTI will be collected.

Patients with confirmed SARS-CoV-2 community-acquired pneumonia, admitted to the participating ICUs from the start of COVID epidemic will be eligible for this study. Those admitted before the beginning of this study will be included retrospectively, and those admitted after the beginning of the study will be included prospectively. 10-20 patients per center will be included in this group. SARSCoV2 infection will be confirmed by a nasopharyngeal PCR or respiratory secretions (tracheal aspirate or bronchoalveolar lavage) PCR. Two retrospective groups will be constituted in order to give some insight of potential impact of SARS-CoV2 infection on the incidence of VALRTI :1) Influenza group : patients with influenza (A or B) community-acquired pneumonia. All patients with influenza community acquired pneumonia and admitted in the same ICU will be eligible in this group.

The number of patients included in this group per center will be similar as that of patients included in the SARS-CoV-2 pneumonia group (10-20 patients). These consecutive patients will by identified using the files of Virology Lab. The first included patient will be the last of the current influenza season (2019-2020), and others will be taken consecutively back to 2019 of 2018 if necessary. PCR (nasopharyngeal or respiratory secretions) confirmation of influenza (A ou B) is required for patients in this group. 2) No viral infection group: patients with no viral community acquired pneumonia. All patients receiving invasive mechanical ventilation for more than 48h before COVID epidemic, for any reason other than viral pneumonia are eligible for this group. The number of included patients in this group will be similar as that of patients included in the SARS-CoV-2 group in the same center (10-20 patients) These consecutive patients will be included starting at the end of January 2020 and going back to 2019 if necessary. VAT and VAP are defined using clinical, radiological and quantitative microbiological criteria.

Conditions

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SARS-CoV 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SARS-CoV2 group

Patients receiving invasive mechanical ventilation for more than 48h with SARS-CoV-2 infection

No interventions assigned to this group

Flu group

Patients receiving invasive mechanical ventilation for more than 48h with influenza infection

No interventions assigned to this group

No viral infection group

Patients receiving invasive mechanical ventilation for more than 48h with no viral infection at ICU admission

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

For all three groups:

* Major patient
* In patients in ICU
* Patients intubated and mechanically ventilated for more than 48 hours.

For the SARS-CoV2 group: community-acquired SARS-CoV2 pneumonia For the influenza group: community-acquired influenza pneumonia For the "No Viral Infection" group: no viral pneumonia on admission.

Exclusion Criteria

* Refusal to participate
* Lack of social security coverage
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Saad Nseir, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hôpital Roger Salengro, ICU, CHU Lille

Lille, , France

Site Status

Countries

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France

References

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Kreitmann L, Bayon C, Martin-Loeches I, Povoa P, Salluh J, Rouze A, Moreau AS, Duhamel A, Labreuche J, Nseir S; Type of iMmunosuppression and the Incidence, Microbiology, and OutcomeS of ventilator-Associated lower respiratory tract infections (MIMOSA) Study Group. Association Between Type of Immunosuppression and the Incidence, Microbiology, and Outcomes of Bacterial Ventilator-Associated Lower Respiratory Tract Infections: A Retrospective Multicenter Study. Crit Care Med. 2025 May 1;53(5):e1080-e1094. doi: 10.1097/CCM.0000000000006615. Epub 2025 Feb 21.

Reference Type DERIVED
PMID: 39982132 (View on PubMed)

Rouze A, Lemaitre E, Martin-Loeches I, Povoa P, Diaz E, Nyga R, Torres A, Metzelard M, Du Cheyron D, Lambiotte F, Tamion F, Labruyere M, Boulle Geronimi C, Luyt CE, Nyunga M, Pouly O, Thille AW, Megarbane B, Saade A, Magira E, Llitjos JF, Ioannidou I, Pierre A, Reignier J, Garot D, Kreitmann L, Baudel JL, Voiriot G, Plantefeve G, Morawiec E, Asfar P, Boyer A, Mekontso-Dessap A, Makris D, Vinsonneau C, Floch PE, Marois C, Ceccato A, Artigas A, Gaudet A, Nora D, Cornu M, Duhamel A, Labreuche J, Nseir S; coVAPid study group. Invasive pulmonary aspergillosis among intubated patients with SARS-CoV-2 or influenza pneumonia: a European multicenter comparative cohort study. Crit Care. 2022 Jan 4;26(1):11. doi: 10.1186/s13054-021-03874-1.

Reference Type DERIVED
PMID: 34983611 (View on PubMed)

Rouze A, Martin-Loeches I, Povoa P, Metzelard M, Du Cheyron D, Lambiotte F, Tamion F, Labruyere M, Boulle Geronimi C, Nieszkowska A, Nyunga M, Pouly O, Thille AW, Megarbane B, Saade A, Diaz E, Magira E, Llitjos JF, Cilloniz C, Ioannidou I, Pierre A, Reignier J, Garot D, Kreitmann L, Baudel JL, Fartoukh M, Plantefeve G, Beurton A, Asfar P, Boyer A, Mekontso-Dessap A, Makris D, Vinsonneau C, Floch PE, Weiss N, Ceccato A, Artigas A, Bouchereau M, Duhamel A, Labreuche J, Nseir S; coVAPid Study Group. Early Bacterial Identification among Intubated Patients with COVID-19 or Influenza Pneumonia: A European Multicenter Comparative Clinical Trial. Am J Respir Crit Care Med. 2021 Sep 1;204(5):546-556. doi: 10.1164/rccm.202101-0030OC.

Reference Type DERIVED
PMID: 34038699 (View on PubMed)

Nseir S, Martin-Loeches I, Povoa P, Metzelard M, Du Cheyron D, Lambiotte F, Tamion F, Labruyere M, Makris D, Boulle Geronimi C, Pinetonde Chambrun M, Nyunga M, Pouly O, Megarbane B, Saade A, Goma G, Magira E, Llitjos JF, Torres A, Ioannidou I, Pierre A, Coelho L, Reignier J, Garot D, Kreitmann L, Baudel JL, Voiriot G, Contou D, Beurton A, Asfar P, Boyer A, Thille AW, Mekontso-Dessap A, Tsolaki V, Vinsonneau C, Floch PE, Le Guennec L, Ceccato A, Artigas A, Bouchereau M, Labreuche J, Duhamel A, Rouze A; coVAPid study group. Relationship between ventilator-associated pneumonia and mortality in COVID-19 patients: a planned ancillary analysis of the coVAPid cohort. Crit Care. 2021 May 25;25(1):177. doi: 10.1186/s13054-021-03588-4.

Reference Type DERIVED
PMID: 34034777 (View on PubMed)

Other Identifiers

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2020-A00995-34

Identifier Type: OTHER

Identifier Source: secondary_id

2020_27

Identifier Type: -

Identifier Source: org_study_id

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