Overview

BL Infusion Trial: Beta-lactam Continuous Versus Intermittent Infusion and Associated Bacterial Resistance and Therapy Outcomes in Critically Ill Patients With Severe Pneumonia

Status:
Not yet recruiting

Trial end date:
2023-12-01

Target enrollment:
0

Participant gender:
All

Summary

The study plans to randomize a total of 240 patients infected with Gram-negative bacterial pneumonia to receive beta-lactam (meropenem, cefepime, or piperacillin/tazobactam) continuous or intermittent infusion and collect baseline and regular follow-up respiratory cultures to assess the development of new resistance. The investigators will measure beta-lactam concentration to assess the impact of drug exposure on the bacterial resistance.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Florida

Collaborator:

Food and Drug Administration (FDA)

Treatments:

Cefepime
Meropenem
Piperacillin
Piperacillin, Tazobactam Drug Combination
Tazobactam

Criteria

Inclusion Criteria:

- Admission to the medical ICU with severe pneumonia defined as per IDSA/ATS 2019
criteria on mechanical ventilation: presence of signs, symptoms and confirmatory chest
imaging consistent with pneumonia (e.g. fever, cough and pulmonary infiltrate by chest
radiograph) requiring mechanical ventilation due to respiratory failure

- Age ≥18 years

- Positive rapid identification test and respiratory culture for Gram-negative bacteria
including, but not limited to, P. aeruginosa, K. pneumoniae, E. coli, S. marcescens,
H. influenzae, Enterobacter spp., M. catarrhalis, A. baumannii, Achromobacter spp., P.
mirabilis, and/or B. cepacia

- Received within the last 48 hours or will receive meropenem, cefepime, or
piperacillin/tazobactam therapy

Exclusion Criteria:

- Pregnancy

- Prisoners

- Allergy to the beta-lactams to be administered in this study

- On renal replacement therapy at the time of randomization

- Gram-negative bacteria identified by rapid testing only with negative respiratory
culture at baseline

- COVID patients enrolled in other trials