Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04348227
Recruitment Status : Active, not recruiting
First Posted : April 16, 2020
Last Update Posted : April 17, 2020
Sponsor:
Information provided by (Responsible Party):
Khemili Malek, Hôpital Universitaire Fattouma Bourguiba

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.

Condition or disease Intervention/treatment
Ventilator Associated Pneumonia Behavioral: Enhanced hygiene measures

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 2 Years
Official Title: How COVID-19 Virus Outbreak Affects Antimicrobial Resistance in a Low-middle-income Country's ICU?
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : January 1, 2020
Estimated Study Completion Date : February 4, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

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.




Primary Outcome Measures :
  1. MDR pathogens in endotracheal aspirates [ Time Frame: 1 year ]
    Incidence of MDR bacteria in endotracheal aspirates


Secondary Outcome Measures :
  1. Microorganisms in endotracheal aspirates [ Time Frame: 1 year ]
    Incidence of microorganisms in endotracheal aspirates


Biospecimen Retention:   Samples Without DNA
Endotracheal aspirates


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

  • Patients requiring mechanical ventilation for more than 24 hours

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04348227


Locations
Layout table for location information
Tunisia
Department of anesthesia and intensive care, Fattouma Bourguiba Hospital
Monastir, Tunisia, 5000
Sponsors and Collaborators
Hôpital Universitaire Fattouma Bourguiba
Investigators
Layout table for investigator information
Principal Investigator: Malek Khemili, Resident Department of anesthesia and intensive care, Fattouma Bourguiba Hospital
Layout table for additonal information
Responsible Party: Khemili Malek, Principal investigator, Hôpital Universitaire Fattouma Bourguiba
ClinicalTrials.gov Identifier: NCT04348227    
Other Study ID Numbers: KM2020-1
First Posted: April 16, 2020    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pneumonia, Ventilator-Associated
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection