Microbial Etiology of Ventilator-associated Pneumonia in... | NCT04344509

Studies
Microbial Etiology of Ventilator-associated Pneumonia in COVID-19 Infected Patients

NCT04344509

Sponsor

Poitiers University Hospital

Status

Unknown status

Last Update Posted

Jun 2, 2020Actual

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Ventilator Associated Pneumonia

Interventions

Bacterial species isolated

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2020Estimated

Primary Completion Date

Sep 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Apr 10, 2020

First Submission Date that Met QC Criteria

Apr 10, 2020

First Posted Date

Apr 14, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 29, 2020

Last Update Posted Date

Jun 2, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
COVID19-positive patients			Other: Bacterial species isolated
COVID19-negative patients			Other: Bacterial species isolated

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bacterial species isolated	Other	in the respiratory specimen	COVID19-negative patients COVID19-positive patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of the microorganisms responsible for VAP among patients infected or not by the SARS-CoV-2		1 month

Secondary Outcomes

Measure	Description	Time Frame
Prevalence of multi-drug resistant bacteria responsible for VAP among patients infected or not by the SARS-CoV-2		1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christophe BURUCOA	Contact	549443889	+33	christophe.burucoa@chu-poitiers.fr

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D053717	Pneumonia, Ventilator-Associated

Ancestor Terms

ID	Term
D000077299	Healthcare-Associated Pneumonia
D003428	Cross Infection
D007239	Infections
D011014	Pneumonia

Browse Leaves

Not provided

Browse Branches

Not provided