NCT06334731

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

July 6, 2021

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 21, 2022

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

March 28, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2025

Completed
Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

4 years

First QC Date

October 21, 2022

Last Update Submit

July 23, 2025

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • Incidence of third generation cephalosporin-resistant bacteria (3GCRB)

    Incidence of third generation cephalosporin-resistant bacteria (3GCRB)

    5 Months

Secondary Outcomes (5)

  • Incidence of ESBLPE

    5 months

  • Incidence of CRB

    5 Months

  • Incidence of other pathogens

    August 2021

  • Incidence of nosocomial infections

    5 Months

  • Incidence of clinical outcomes

    5 Months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients admitted to Methodist Richardson, Methodist Mansfield, Methodist Charlton, or Methodist Dallas Medical Centers between March 2018 and August 2021.
  • \>18 years old

You may not qualify if:

  • Outpatient visit
  • Not admitted to an inpatient or observation status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Mathew Crotty, PharmD

    The Methodist Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2022

First Posted

March 28, 2024

Study Start

July 6, 2021

Primary Completion

July 14, 2025

Study Completion

July 14, 2025

Last Updated

July 28, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)