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

University of Florida

Status and phase: Terminated; Phase 4

Conditions: Pneumonia

Treatments: Drug: Cefepime, Meropenem, or Piperacillin/Tazobactam

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05102162

IRB202101979 -A

OCR41108 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Admission to the ICU with severe pneumonia (IDSA/ATS 2016/2019): presence of signs, symptoms and confirmatory chest imaging consistent with pneumonia (e.g. fever, cough and pulmonary infiltrate by chest radiograph)
• Age ≥18 years
• Positive respiratory culture (with or without an initial positive rapid identification test and/or Gram stain) 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 72 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
• Baseline culture resistant to the beta-lactams in the study
• COVID patients enrolled in other trials

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Continuous Antibiotic Dose Over 24 hours Arm

Active Comparator group

Description:

Subjects will be receiving a continuous dose of antibiotic prescribed by their doctor for the duration they choose.

Treatment:

Drug: Cefepime, Meropenem, or Piperacillin/Tazobactam

Drug: Cefepime, Meropenem, or Piperacillin/Tazobactam

Intermittent Antibiotic Dose Over 30 minutes

Active Comparator group

Description:

Subjects will be receiving an intermittent dose of antibiotic prescribed by their doctor for the duration they choose.

Treatment:

Drug: Cefepime, Meropenem, or Piperacillin/Tazobactam

Drug: Cefepime, Meropenem, or Piperacillin/Tazobactam