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NCT06334731 Clinical Trial

Antimicrobial Resistance During the SARS-CoV-2 (COVID-19) Pandemic

COVID-19 Clinical Trial

Official title:
What Happened? Antimicrobial Resistance During the SARS-CoV-2 (COVID-19) Pandemic

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06334731
Other study ID # 045.PHA.2021.D
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 6, 2021
Est. completion date December 2024

Study information
Verified date March 2024
Source Methodist Health System
Contact Crystee Cooper, DHEd
Phone 214-947-1280
Email clinicalresearch@mhd.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Assess the incidence and rates of resistant pathogens prior to and during the COVID-19 pandemic.

Description:

The COVID-19 pandemic accelerated/exacerbated resistance rates for key pathogens. Specifically, incidence of extended-spectrum beta-lactamase producing Enterobacteriaceae (ESBLPE), carbapenem-resistant bacteria (CRB), methicillin-resistant Staphyloccoccus aureus (MRSA), vancomycin-resistant Enterococci (VRE), and C. difficile infections (CDI) will be higher in the pandemic time period (Pandemic, March 2020 - February 2025) compared to the pre-pandemic period (Pre-Pandemic, March 2018 - February 2020).

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - • Patients admitted to Methodist Richardson, Methodist Mansfield, Methodist Charlton, or Methodist Dallas Medical Centers between March 2018 and August 2021. - >18 years old Exclusion Criteria: - • Outpatient visit - Not admitted to an inpatient or observation status

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Methodist Dallas Medical Center Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of third generation cephalosporin-resistant bacteria (3GCRB) Incidence of third generation cephalosporin-resistant bacteria (3GCRB) 5 Months
Secondary Incidence of ESBLPE Incidence of ESBLPE 5 months
Secondary Incidence of CRB Incidence of CRB 5 Months
Secondary Incidence of other pathogens MRSA
VRE
CDI		 August 2021
Secondary Incidence of nosocomial infections Catheter-associated urinary tract infection (CAUTI)
Central line-associated bloodstream infection (CLABSI)
Possible ventilator-associated pneumonia (PVAP)		 5 Months
Secondary Incidence of clinical outcomes death, recovery, long-term care facility, etc. 5 Months
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