Antimicrobial Resistance During the SARS-CoV-2 (COVID-19)... | NCT06334731

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

NCT06334731

Sponsor

Methodist Health System

Status

Completed

Last Update Posted

Jul 28, 2025Actual

Enrollment

400Actual

Phase

Not provided

Conditions

COVID-19

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 6, 2021Actual

Primary Completion Date

Jul 14, 2025Actual

Completion Date

Jul 14, 2025Actual

First Submitted Date

Oct 21, 2022

First Submission Date that Met QC Criteria

Mar 26, 2024

First Posted Date

Mar 28, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2025

Last Update Posted Date

Jul 28, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed 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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of third generation cephalosporin-resistant bacteria (3GCRB)	Incidence of third generation cephalosporin-resistant bacteria (3GCRB)	5 Months

Secondary Outcomes

Measure	Description	Time Frame
Incidence of ESBLPE	Incidence of ESBLPE	5 months
Incidence of CRB	Incidence of CRB	5 Months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients admitted to Methodist Richardson, Methodist Mansfield, Methodist Charlton, or Methodist Dallas Medical Centers between March 2018 and August 2021.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mathew Crotty, PharmD	The Methodist Hospital Research Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Methodist Dallas Medical Center		Dallas	Texas	75203	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided