NCT04348227

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 16, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2021

Completed
Last Updated

April 17, 2020

Status Verified

April 1, 2020

Enrollment Period

1 year

First QC Date

April 10, 2020

Last Update Submit

April 16, 2020

Conditions

Ventilator Associated Pneumonia

Outcome Measures

Primary Outcomes (1)

  • MDR pathogens in endotracheal aspirates

    Incidence of MDR bacteria in endotracheal aspirates

    1 year

Secondary Outcomes (1)

  • Microorganisms in endotracheal aspirates

    1 year

Study Arms (2)

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

Enhanced hygiene measuresBEHAVIORAL

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.

After pandemic is declared

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients requiring mechanical ventilation for more than 24 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of anesthesia and intensive care, Fattouma Bourguiba Hospital

Monastir, 5000, Tunisia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Endotracheal aspirates

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

Study Officials

  • Malek Khemili, Resident

    Department of anesthesia and intensive care, Fattouma Bourguiba Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 10, 2020

First Posted

April 16, 2020

Study Start

January 1, 2019

Primary Completion

January 1, 2020

Study Completion

February 4, 2021

Last Updated

April 17, 2020

Record last verified: 2020-04

Locations

TU(1)