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

Completed

Conditions studied: Gram-Negative Bacterial Infections

In brief

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.

Key facts

Study ID

NCT05171257

Run by

Methodist Health System

People needed

197

Starts

2021-10-19

Expected to finish

2025-07-14

Last updated by the study team

2026-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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 that received antibiotics within five days prior to study inclusion
• Patients on more than one anti-pseudomonal beta-lactam antibiotics (excluding emergency department doses) during previous exposure

Where it is running

• Methodist Dallas Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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