Quantifying Gram-negative Resistance to Empiric Therapy in the Intensive Care Unit

NCT05171257 | Completed

• 1 other identifier: 038.PHA.2021.D
• Study Type: observational
• Target: 197
• Locations: 1 country
• Sites: 1

Brief Summary

Antimicrobial resistance is a global health emergency estimated to be responsible for 700,000 deaths per year worldwide, and it is well known that previous antibiotic exposure is the single most contributing factor. For example, the use of non-antipseudomonal agents can increase risk for any P. aeruginosa strain; however, the use of an agent with antipseudomonal activity would select for resistance to that particular antimicrobial agent or class. Demonstrated that each additional day of exposure to any antipseudomonal beta-lactam is associated with an increased risk of new resistance development. The study seeks to determine whether the choice of empiric therapy (i.e., the same agent versus a different agent from prior antibiotic exposure) has any effect on the likelihood of in vitro activity against GN pathogens (GNPs) in a subsequent infection.

Conditions

Gram-Negative Bacterial Infections

Outcome Measures

Primary Outcomes (1)

• Rates of resistance

  Rates of resistance in patients receiving empiric therapy with the same IV antibiotics from prior (repeat group) compared to rates of resistance in patients receiving differing IV antibiotics from prior (change group)

  charts from 4/1/2017 to 3/31/2021

Secondary Outcomes (1)

• Intensive Care Unite LOS(ICU LOS)

  charts from 4/1/2017 to 3/31/2021

Study Arms (2)

repeat group

patients receiving empiric therapy with the same IV antibiotics from prior

Drug: IV antibiotic treatment from prior

change group

patients receiving differing IV antibiotics from prior

Drug: differing IV antibiotic treatment

Interventions

IV antibiotic treatment from prior DRUG

patients receiving same IV antibiotic treatment from prior

repeat group

differing IV antibiotic treatment DRUG

patients receiving differing IV antibiotics from prior

change group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

sample size of 242 (121 patients in each group)

You may qualify if:

• ≥18 years of age
• GNP pneumonia or bacteremia during hospital admission
• Previous IV antibiotics for at least 48 hours in the past 90 days
• Culture MIC data available

You may not qualify if:

• Patients with a history of isolate resistance in the previous six months to antibiotics being studied
• Patients on more than one anti-pseudomonal beta-lactam antibiotics (excluding emergency department doses) during previous exposure

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Gram-Negative Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Mathew Crotty, MD

  Methodist

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: December 28, 2021
• Study Start: October 19, 2021
• Primary Completion: July 14, 2025
• Study Completion: July 14, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)