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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

Primary Purpose

Pneumonia

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Cefepime, Meropenem, or Piperacillin/Tazobactam

About this trial

This is an interventional treatment trial for Pneumonia

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Continuous Antibiotic Dose Over 24 hours Arm

Intermittent Antibiotic Dose Over 30 minutes

Arm Description

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

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

Outcomes

Primary Outcome Measures

Compare the incidence of Gram-negative bacterial resistance between patients treated with continuous and intermittent infusion beta-lactam regimens

Secondary Outcome Measures

Full Information

NCT ID

NCT05102162

First Posted

October 29, 2021

Last Updated

May 30, 2023

Sponsor

University of Florida

Collaborators

Food and Drug Administration (FDA)

1. Study Identification

Unique Protocol Identification Number

NCT05102162

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 17, 2021 (Actual)

Primary Completion Date

October 6, 2023 (Anticipated)

Study Completion Date

October 6, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Florida

Collaborators

Food and Drug Administration (FDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pneumonia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Continuous Antibiotic Dose Over 24 hours Arm

Arm Type

Active Comparator

Arm Description

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

Arm Title

Intermittent Antibiotic Dose Over 30 minutes

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Cefepime, Meropenem, or Piperacillin/Tazobactam

Other Intervention Name(s)

Maxipime, Merrem

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

Cefepime, Meropenem, or Piperacillin/Tazobactam

Other Intervention Name(s)

Maxipime, Merrem

Intervention Description

Primary Outcome Measure Information:

Title

Compare the incidence of Gram-negative bacterial resistance between patients treated with continuous and intermittent infusion beta-lactam regimens

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Charles Peloquin

Organizational Affiliation

University of Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Charles Peloquin

Phone

352-273-6266

peloquin@cop.ufl.edu

First Name & Middle Initial & Last Name & Degree

Nicole Maranchick, PharmD

Phone

352-273-6803

n.maranchick@cop.ufl.edu

First Name & Middle Initial & Last Name & Degree

Charles Peloquin

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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