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

• Sponsor: Hôpital Universitaire Fattouma Bourguiba (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04348227
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Anticipated Duration (Months): 25.1
• Patients Per Site Per Month: 4.8

Study Details

Study Description

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	Phase
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.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 120 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: How COVID-19 Virus Outbreak Affects Antimicrobial Resistance in a Low-middle-income Country's ICU?
• Actual Study Start Date: Jan 1, 2019
• Actual Primary Completion Date: Jan 1, 2020
• Anticipated Study Completion Date: Feb 4, 2021

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. MDR pathogens in endotracheal aspirates [1 year]

   Incidence of MDR bacteria in endotracheal aspirates

Secondary Outcome Measures

1. Microorganisms in endotracheal aspirates [1 year]

   Incidence of microorganisms in endotracheal aspirates

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients requiring mechanical ventilation for more than 24 hours

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of anesthesia and intensive care, Fattouma Bourguiba Hospital	Monastir		Tunisia	5000

Sponsors and Collaborators

• Hôpital Universitaire Fattouma Bourguiba

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Khemili Malek, Principal investigator, Hôpital Universitaire Fattouma Bourguiba
• ClinicalTrials.gov Identifier: NCT04348227
• Other Study ID Numbers: KM2020-1
• First Posted: Apr 16, 2020
• Last Update Posted: Apr 17, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pneumonia, Ventilator-Associated

Study Results

No Results Posted as of Apr 17, 2020