NCT04344509

Brief Summary

National multicentric observational retrospective case-control study comparing the relative frequency of the various microorganisms responsible for VAP in patients infected or not by SARS-CoV-2 and their resistance to antibiotics.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Status
unknown

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 10, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 14, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

June 2, 2020

Status Verified

April 1, 2020

Enrollment Period

3 months

First QC Date

April 10, 2020

Last Update Submit

May 29, 2020

Conditions

Ventilator Associated Pneumonia

Outcome Measures

Primary Outcomes (1)

  • Prevalence of the microorganisms responsible for VAP among patients infected or not by the SARS-CoV-2

    1 month

Secondary Outcomes (1)

  • Prevalence of multi-drug resistant bacteria responsible for VAP among patients infected or not by the SARS-CoV-2

    1 month

Study Arms (2)

COVID19-positive patients

Other: Bacterial species isolated

COVID19-negative patients

Other: Bacterial species isolated

Interventions

Bacterial species isolatedOTHER

in the respiratory specimen

COVID19-negative patientsCOVID19-positive patients

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with microbiologically confirmed VAP with pulmonary samples collected from March 15 to April 15 in France.

You may qualify if:

  • All patients with microbiologically confirmed VAP with pulmonary samples collected from March 15 to April 15 in France.

You may not qualify if:

  • All patients with microbiologically confirmed VAP with pulmonary samples collected from March 15 to April 15 in France.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Christophe BURUCOA

CONTACT

549443889christophe.burucoa@chu-poitiers.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2020

First Posted

April 14, 2020

Study Start

June 1, 2020

Primary Completion

September 1, 2020

Study Completion

December 1, 2020

Last Updated

June 2, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share