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

SARS-CoV 2 Clinical Trial

— COVAPID  

Official title:

Impact of SARS-CoV-2 Infection on the Incidence of Ventilator-acquired Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04359693
• Other study ID #: 2020_27
• Secondary ID: 2020-A00995-34
• Status: Completed
• Start date: April 22, 2020
• Est. completion date: July 1, 2020

Study information

• Verified date: July 2020
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1576
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infection
• SARS-CoV 2

Locations

Country	Name	City	State
France	Hôpital Roger Salengro, ICU, CHU Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cumulative incidence of ventilator-associated tracheobronchitis	incidence of ventilator-associated tracheobronchitis	from day 3 of mechanical ventilation to extubation or day 28 post intubation
Secondary	Cumulative incidence of ventilator-associated pneumonia	incidence of ventilator-associated pneumonia	from Day 3 of mechanical ventilation to extubation or day 28 post intubation.
Secondary	the cumulative incidence of ICU acquired bacteremia diagnosed	incidence of ICU-acquired bacteremia	from ICU admission to extubation or Day 28.
Secondary	ICU mortality	death in the ICU	at day 28
Secondary	Mortality	death	at day 28
Secondary	the duration of mechanical ventilation	number of days Under mechanical ventilation	from the start of mechanical ventilation to extubation or day 28 post intubation
Secondary	Length of stay in Intensive Care Unit	number of days in the ICU	from admission to ICU until extubation or Day 28