BL Infusion Trial:Beta-lactam Continuous Versus Intermittent Infusion and Associated Bacterial Resistance and Therapy Outcomes in Critically Ill Patients With Severe Pneumonia
NCT ID: NCT05102162
Last Updated: 2023-12-12
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
35 participants
INTERVENTIONAL
2021-12-17
2023-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Continuous Antibiotic Dose Over 24 hours Arm
Subjects will be receiving a continuous dose of antibiotic prescribed by their doctor for the duration they choose.
Cefepime, Meropenem, or Piperacillin/Tazobactam
A 1:1 randomization scheme based on the infusion duration (continuous over 24 hours or intermittent over 30 minutes) with stratification based on the beta-lactam prescribed (cefepime, meropenem, or piperacillin/tazobactam)
Intermittent Antibiotic Dose Over 30 minutes
Subjects will be receiving an intermittent dose of antibiotic prescribed by their doctor for the duration they choose.
Cefepime, Meropenem, or Piperacillin/Tazobactam
A 1:1 randomization scheme based on the infusion duration (continuous over 24 hours or intermittent over 30 minutes) with stratification based on the beta-lactam prescribed (cefepime, meropenem, or piperacillin/tazobactam)
Interventions
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Cefepime, Meropenem, or Piperacillin/Tazobactam
A 1:1 randomization scheme based on the infusion duration (continuous over 24 hours or intermittent over 30 minutes) with stratification based on the beta-lactam prescribed (cefepime, meropenem, or piperacillin/tazobactam)
Cefepime, Meropenem, or Piperacillin/Tazobactam
A 1:1 randomization scheme based on the infusion duration (continuous over 24 hours or intermittent over 30 minutes) with stratification based on the beta-lactam prescribed (cefepime, meropenem, or piperacillin/tazobactam)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
100 Years
ALL
No
Sponsors
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Food and Drug Administration (FDA)
FED
University of Florida
OTHER
Responsible Party
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Principal Investigators
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Charles Peloquin
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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University of Florida
Gainesville, Florida, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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OCR41108
Identifier Type: OTHER
Identifier Source: secondary_id
IRB202101979 -A
Identifier Type: -
Identifier Source: org_study_id