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Pharmacokinetics of Ceftolozane/Tazobactam in Patients With Burns

NCT03002506 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-03-02

Study results available
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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

Interventions

DRUG

Ceftolozane/tazobactam

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

Sponsors & Collaborators

Principal Investigators

  • Ronald G Hall, PharmD · Texas Tech University HSC

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-21
Primary Completion
2020-06-01
Completion
2020-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03002506 on ClinicalTrials.gov