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

ClinicalTrials.gov ID: NCT05171257

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Official title

Quantifying Gram-negative Resistance to Empiric Therapy in the Intensive Care Unit - Repeat ExpoSure to AntimicRobial Therapy (RESTART)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT05171257
Recruitment status: Completed
Study type: Observational
Phase: Not listed
Lead sponsor: Methodist Health System; Other
Enrollment: 197 participants

Conditions and interventions

Conditions

Gram-Negative Bacterial Infections

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Oct 19, 2021 (Actual)
Primary completion: Jul 14, 2025 (Actual)
Completion: Jul 14, 2025 (Actual)
Last update posted: Mar 27, 2026

2021 – 2025

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Methodist Dallas Medical Center	Dallas	Texas	75203	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05171257, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Mar 27, 2026 · Synced Nov 14, 2026