Multi-Drug Resistant Organism (MDRO): Study of Highly Resistant Escherichia Coli

NCT04574596 | Completed

• 2 other identifiers: Pro00106280UM1AI104681
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 13

Brief Summary

This is a prospective, observational, multicenter, case-control study.

Conditions

E Coli Infection

Keywords

Extended Spectrum β-Lactamases (ESBL)

Outcome Measures

Primary Outcomes (1)

• Number of participants who received oral step-down therapy

  Number of participants who received oral-step down therapy for treatment of e. Coli

  Within 30 days of culture collection

Secondary Outcomes (18)

• Duration of antibiotics

  From culture collection to 30 days post culture collection

• Duration of intravenous antibiotics

  From culture collection to 30 days post culture collection

• Duration of oral antibiotics

  From culture collection to 30 days post culture collection

• Number of participants who received short course antibiotic therapy

  From culture collection to 30 days post culture collection

• Number of participants with ongoing antibiotic treatment at 30 days

  30 days post culture collection

Other Outcomes (3)

• Antibiotic resistance phenotype

  Day 0, which is the date of culture collection in this observational study

• Antimicrobial resistance genes

  Day 0, which is the date of culture collection in this observational study

• Duration of individual antibiotics and specific combinations of antibiotics

  culture collection through 30 days post culture collection

Study Arms (2)

3GCR ceftriaxone-resistant-E. coli

Positive blood culture for above resistant e coli. Observational there will be no intervention

Other: no Intervention

3GCS ceftriaxone-susceptible-E. coli

Positive blood culture for above susceptible e coli. Observational there will be no intervention

Other: no Intervention

Interventions

no Intervention OTHER

This is an observational study. There is no intervention

3GCR ceftriaxone-resistant-E. coli; 3GCS ceftriaxone-susceptible-E. coli

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Sample size: 300 total: 150 3GCR-Ec cases, 150 3GCS-Ec controls. * This is a consecutive cohort study without age or gender exclusions. Special populations such as women, children, and minorities will be included. * The study population will be drawn from subjects who are hospitalized at participating study hospitals. * This observational study is minimal-risk and will be performed under a waiver of consent and HIPAA.

You may qualify if:

• Positive monomicrobial blood culture for 3GCR-Ec (cases) or 3GCS-Ec (control)
• Hospitalized at the time of obtaining index blood culture OR in the emergency department at the time of obtaining index blood culture, if followed by hospitalization within 72 hours

You may not qualify if:

• Previously included in this study as either control or case subject
• Previous blood culture positive for E. coli during the current hospitalization
• In vitro non-susceptibility to any carbapenem tested in the local clinical microbiology laboratory
• Evidence of carbapenemase production in the E. coli isolate of interest as determined by the local clinical microbiology laboratory

Sponsors & Collaborators

• Duke University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (13)

Harbor-University of California Los Angeles Medical Center

Torrance, California, 90502, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 21287, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106-7282, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15261, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

3GCRceftriaxone-resistant-E. coli in blood culture Control group 3GCSceftriaxone-susceptible-E. coli in a blood culture :

MeSH Terms

Conditions

Escherichia coli Infections

Condition Hierarchy (Ancestors)

Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Vance G. Fowler, MD

  Duke Clinical Research Institute

  STUDY DIRECTOR

• David van Duin, MD, PhD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: October 5, 2020
• Study Start: November 12, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: July 27, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)