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

Sponsor
University of Florida (Other)
Overall Status
Recruiting
CT.gov ID
NCT05102162
Collaborator
Food and Drug Administration (FDA) (U.S. Fed)
240
Enrollment
1
Location
2
Arms
23.5
Anticipated Duration (Months)
10.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Cefepime, Meropenem, or Piperacillin/Tazobactam
  • Drug: Cefepime, Meropenem, or Piperacillin/Tazobactam
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Beta-lactam Continuous Versus Intermittent Infusion and Associated Bacterial Resistance and Therapy Outcomes in Critically Ill Patients With Severe Pneumonia
Actual Study Start Date :
Dec 17, 2021
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

Drug: 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 Names:
  • Maxipime, Merrem

    		•
    Active Comparator: Intermittent Antibiotic Dose Over 30 minutes

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

    Drug: 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 Names:
  • Maxipime, Merrem

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Compare the incidence of Gram-negative bacterial resistance between patients treated with continuous and intermittent infusion beta-lactam regimens [4 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.,

    1. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Florida Gainesville Florida United States 32610

    Sponsors and Collaborators

    • University of Florida
    • Food and Drug Administration (FDA)

    Investigators

    • Principal Investigator: Mohammad Alshaer, Pharm.D., PhD, University of Florida

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Florida
    ClinicalTrials.gov Identifier:
    NCT05102162
    Other Study ID Numbers:
    • IRB202101979 -A
    • OCR41108
    First Posted:
    Nov 1, 2021
    Last Update Posted:
    Mar 14, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Pneumonia
    Meropenem
    Tazobactam
    Piperacillin
    Cefepime
    Piperacillin, Tazobactam Drug Combination

    Study Results

    No Results Posted as of Mar 14, 2022