How COVID-19 Virus Outbreak Affects Antimicrobial Resista... | NCT04348227

Studies
How COVID-19 Virus Outbreak Affects Antimicrobial Resistance in a Low-middle-income Country's ICU?

NCT04348227

Sponsor

Hôpital Universitaire Fattouma Bourguiba

Status

Unknown status

Last Update Posted

Apr 17, 2020Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Ventilator Associated Pneumonia

Interventions

Enhanced hygiene measures

Countries

Tunisia

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

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Jan 1, 2020Actual

Completion Date

Feb 4, 2021Estimated

First Submitted Date

Apr 10, 2020

First Submission Date that Met QC Criteria

Apr 14, 2020

First Posted Date

Apr 16, 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

Apr 16, 2020

Last Update Posted Date

Apr 17, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Khemili Malek, Principal investigator, Hôpital Universitaire Fattouma BourguibaPrincipal Investigator

Lead Sponsor

Hôpital Universitaire Fattouma BourguibaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

A previous study showed a high incidence of ventilator-associated pneumonia to multidrug resistant pathogens in our ICU. That has been related to lack of compliance to hand hygiene among health care providers in ou ICU.

Detailed Description

A single-center cohort study performed in the department of Anesthesia and Intensive Care in our Hospital. All endotracheal isolates realised in the period of study are collected from the Department of Microbiology of our Hospital.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Before pandemic is declared		Positive endotracheal aspirates addressed from January 1st 2019 to January 1st 2020
After pandemic is declared		Positive endotracheal aspirates addressed from February1st 2020 to February 1st 2021	Behavioral: Enhanced hygiene measures

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Enhanced hygiene measures	Behavioral	Wether or not hygiene measures dictated by the pandemic of severe acute respiratory syndrome coronavirus 19 , reduce multi drug resistant pathogens isolated in endotracheal aspirates.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MDR pathogens in endotracheal aspirates	Incidence of MDR bacteria in endotracheal aspirates	1 year

Secondary Outcomes

Measure	Description	Time Frame
Microorganisms in endotracheal aspirates	Incidence of microorganisms in endotracheal aspirates	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients requiring mechanical ventilation for more than 24 hours

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients admitted in ICU in the period of the study, requiring mechanical ventilation for more than 24 hours

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Malek Khemili, Resident	Department of anesthesia and intensive care, Fattouma Bourguiba Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of anesthesia and intensive care, Fattouma Bourguiba Hospital		Monastir		5000	Tunisia

IPD Sharing Statement Module

Plan to Share IPD

Undecided

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