NCT04359693

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,576

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

April 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

April 22, 2026

Status Verified

July 1, 2020

Enrollment Period

2 months

First QC Date

April 21, 2020

Last Update Submit

April 17, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cumulative incidence of ventilator-associated lower respiratory tract infection

    the incidence of ventilator associated pneumonia and ventilator associated tracheobronchitis

    from day 3 of mechanical ventilation to extubation or day 28 post-intubation.

Secondary Outcomes (7)

  • Cumulative incidence of ventilator-associated tracheobronchitis

    from day 3 of mechanical ventilation to extubation or day 28 post intubation

  • Cumulative incidence of ventilator-associated pneumonia

    from Day 3 of mechanical ventilation to extubation or day 28 post intubation.

  • the cumulative incidence of ICU acquired bacteremia diagnosed

    from ICU admission to extubation or Day 28.

  • ICU mortality

    at day 28

  • Mortality

    at day 28

  • +2 more secondary outcomes

Study Arms (3)

SARS-CoV2 group

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

Flu group

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

No viral infection group

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients suspected of pulmonary infection and admitted in ICU

You may qualify if:

  • 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.

You may not qualify if:

  • Refusal to participate
  • Lack of social security coverage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Roger Salengro, ICU, CHU Lille

Lille, 59037, France

Location

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • 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.

Study Officials

  • Saad Nseir, MD,PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 21, 2020

First Posted

April 24, 2020

Study Start

April 22, 2020

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

April 22, 2026

Record last verified: 2020-07

Locations