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Pharmacokinetics of Ceftolozane/Tazobactam in Patients With Burns

Primary Purpose

Burns, Pharmacokinetics

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Ceftolozane/tazobactam

About this trial

This is an interventional other trial for Burns focused on measuring ceftolozane, tazobactam

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male and female subjects, ages 18-80 years, of all racial and ethnic origins.
Non-English Spanish speakers will be included in the study.
We are recruiting 12 patients with thermal burn injuries (percent total body surface area burned >/= 20%). Patients will be at least five days from the date of the burn injury.
Patients will have central venous or arterial line access.
Patients will be already be receiving standard of care antimicrobial therapy for a suspected infection.

Exclusion Criteria:

Pregnant or nursing or unwilling to use a reliable contraception method during the study. The effects of ceftolozane and tazobactam on pregnancy are unknown. In addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of ceftolozane and tazobactam, so that the pregnancy and post-partum state would be a confounding variable.
Abnormal liver function tests: transaminases >10 times upper limit of normal, Alkaline phosphatase >5 times upper limit of normal, total bilirubin >5 times upper limit of normal.
History of allergies to beta-lactam antibiotics.
Patients unwilling to comply with study procedures.
Current or previous participation within 28 days of enrollment in another research study that involves the use of medication, contrast, or any other compound that may alter blood count and/or blood chemistry (liver function, kidney function or electrolyte balance), unless waved by principal investigator (PI).
Donation of 450mL (one unit) of blood or more within 8 weeks (56 days) prior to study enrollment, unless waved by PI.
Creatinine clearance < 30 ml/min as estimated by the Cockcroft-Gault equation.
Patients who are receiving piperazillin/tazobactam or have received piperacillin/tazobactam within the past 48 hours.
Patients who are receiving vasopressors.
Patients with a total body weight < 60 kg or > 130 kg.

Sites / Locations

University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ceftolozane/tazobactam

Arm Description

One dose of 3 grams ceftolozane/tazobactam will be administered to each study participant.

Outcomes

Primary Outcome Measures

Ceftolozane Clearnace

Liters/hour (continuous values)

Secondary Outcome Measures

Full Information

NCT ID

NCT03002506

First Posted

December 21, 2016

Last Updated

March 1, 2021

Sponsor

Texas Tech University Health Sciences Center

Collaborators

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT03002506

Brief Title

Pharmacokinetics of Ceftolozane/Tazobactam in Patients With Burns

Official Title

Pharmacokinetics of Ceftolozane/Tazobactam in Patients With Burns

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Terminated

Why Stopped

Much slower recruitment than anticipated

Study Start Date

August 21, 2017 (Actual)

Primary Completion Date

June 1, 2020 (Actual)

Study Completion Date

June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Texas Tech University Health Sciences Center

Collaborators

Merck Sharp & Dohme LLC

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

Yes

5. Study Description

Brief Summary

This study will help provide information about how patients with burn handle two antibiotics (ceftolozane and tazobactam) and use that information to guide dosing recommendations for these patients. The 12 patients who complete the study will receive a single dose of 3 grams ceftolozane/tazobactam intravenously. We will collect blood and urine samples to determine how much of each antibiotic is in the body and urine at various times over a 24 hour period. This information will be used with previously published information from microbiology laboratories to perform simulations that will provide recommendations on optimal dosing recommendations of these antibiotics in patients with burns.

Detailed Description

A single dose pharmacokinetic study of ceftolozane and tazobactam will be conducted in patients with burns at the Burn Center at University Medical Center. A total of 12 adults aged 18 to 80 years with >/= 20% percent total body surface area burned will be required to complete the study. A single intravenous dose of ceftolozane and tazobactam of 2 grams/1 gram will be administered over 60 minutes and whole blood will be obtained predose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours following the start of infusion. Urine samples (5 ml) will be collected from a urine collection bag (if the patient has urinated) at the following timepoints: 0-0.5, 0.5-1, 1-2, 2-4, 4-8, 8-12, and 12-24 hours for analysis of ceftolozane and tazobactam content. Urine for collected during each time period will be measured to determine urine volume for urine clearance calculations. The volume of urine in the urine over the entire 24 hour period and an aliquot sent for analysis of urine creatinine content to determine the patient's 24 hour creatinine clearance.

6. Conditions and Keywords

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

Burns, Pharmacokinetics

Keywords

ceftolozane, tazobactam

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ceftolozane/tazobactam

Arm Type

Experimental

Arm Description

One dose of 3 grams ceftolozane/tazobactam will be administered to each study participant.

Intervention Type

Drug

Intervention Name(s)

Ceftolozane/tazobactam

Other Intervention Name(s)

Zerbaxa

Intervention Description

Single dose of 2 grams/1 gram intravenously administered over 60 minutes.

Primary Outcome Measure Information:

Title

Ceftolozane Clearnace

Description

Liters/hour (continuous values)

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female subjects, ages 18-80 years, of all racial and ethnic origins. Non-English Spanish speakers will be included in the study. We are recruiting 12 patients with thermal burn injuries (percent total body surface area burned >/= 20%). Patients will be at least five days from the date of the burn injury. Patients will have central venous or arterial line access. Patients will be already be receiving standard of care antimicrobial therapy for a suspected infection. Exclusion Criteria: Pregnant or nursing or unwilling to use a reliable contraception method during the study. The effects of ceftolozane and tazobactam on pregnancy are unknown. In addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of ceftolozane and tazobactam, so that the pregnancy and post-partum state would be a confounding variable. Abnormal liver function tests: transaminases >10 times upper limit of normal, Alkaline phosphatase >5 times upper limit of normal, total bilirubin >5 times upper limit of normal. History of allergies to beta-lactam antibiotics. Patients unwilling to comply with study procedures. Current or previous participation within 28 days of enrollment in another research study that involves the use of medication, contrast, or any other compound that may alter blood count and/or blood chemistry (liver function, kidney function or electrolyte balance), unless waved by principal investigator (PI). Donation of 450mL (one unit) of blood or more within 8 weeks (56 days) prior to study enrollment, unless waved by PI. Creatinine clearance < 30 ml/min as estimated by the Cockcroft-Gault equation. Patients who are receiving piperazillin/tazobactam or have received piperacillin/tazobactam within the past 48 hours. Patients who are receiving vasopressors. Patients with a total body weight < 60 kg or > 130 kg.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ronald G Hall, PharmD

Organizational Affiliation

Texas Tech University HSC

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Medical Center

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79415

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Pharmacokinetics of Ceftolozane/Tazobactam in Patients With Burns

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