Pharmacokinetics of Ceftolozane/Tazobactam in Patients With Burns

NCT03002506 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 070619
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns; Pharmacokinetics

Keywords

ceftolozane; tazobactam

Outcome Measures

Primary Outcomes (1)

• Ceftolozane Clearnace

  Liters/hour (continuous values)

  24 hours

Study Arms (1)

ceftolozane/tazobactam

EXPERIMENTAL

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

Drug: Ceftolozane/tazobactam

Interventions

Ceftolozane/tazobactam DRUG

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

Also known as: Zerbaxa

ceftolozane/tazobactam

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University Medical Center

Lubbock, Texas, 79415, United States

Location

MeSH Terms

Conditions

Burns

Interventions

ceftolozane, tazobactam drug combination

Condition Hierarchy (Ancestors)

Wounds and Injuries

Limitations and Caveats

Single-dose pharmacokinetic study. No clinical outcomes to evaluate efficacy. No safety data provided by this study beyond a single dose in this population.

Results Point of Contact

• Title: Ronald Hall, PharmD, MSCS
• Organization: Texas Tech UHSC

ronald.hall@ttuhsc.edu

214-358-9009

Study Officials

• Ronald G Hall, PharmD

  Texas Tech University HSC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: December 23, 2016
• Study Start: August 21, 2017
• Primary Completion: June 1, 2020
• Study Completion: June 30, 2020
• Last Updated: March 2, 2021
• Results First Posted: March 2, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)