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

April 16, 2020 updated by: Khemili Malek, Hôpital Universitaire Fattouma Bourguiba
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Monastir, Tunisia, 5000
        • Department of anesthesia and intensive care, Fattouma Bourguiba Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Patients requiring mechanical ventilation for more than 24 hours

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital Universitaire Fattouma Bourguiba

Investigators

  • Principal Investigator: Malek Khemili, Resident, Department of anesthesia and intensive care, Fattouma Bourguiba Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

January 1, 2020

Study Completion (Anticipated)

February 4, 2021

Study Registration Dates

First Submitted

April 10, 2020

First Submitted That Met QC Criteria

April 14, 2020

First Posted (Actual)

April 16, 2020

Study Record Updates

Last Update Posted (Actual)

April 17, 2020

Last Update Submitted That Met QC Criteria

April 16, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KM2020-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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