Pharmacokinetics of Ceftolozane/Tazobactam in Patients With Burns
Condition: Burns; Pharmacokinetics
MeSH terms: Burns
Intervention: Ceftolozane/tazobactam
Intervention description: Single dose of 2 grams/1 gram intravenously administered over 60 minutes.
Intervention MeSH terms: Tazobactam; Ceftolozane; Ceftolozane, tazobactam drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: ceftolozane; tazobactam

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female subjects, ages 18-80 years, of all racial and ethnic origins.

          2. Non-English Spanish speakers will be included in the study.

          3. 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.

          4. Patients will have central venous or arterial line access.

          5. Patients will be already be receiving standard of care antimicrobial therapy for a
             suspected infection.

        Exclusion Criteria:

          1. 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.

          2. 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.

          3. History of allergies to beta-lactam antibiotics.

          4. Patients unwilling to comply with study procedures.

          5. 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).

          6. Donation of 450mL (one unit) of blood or more within 8 weeks (56 days) prior to study
             enrollment, unless waved by PI.

          7. Creatinine clearance < 30 ml/min as estimated by the Cockcroft-Gault equation.

          8. Patients who are receiving piperazillin/tazobactam or have received
             piperacillin/tazobactam within the past 48 hours.

          9. Patients who are receiving vasopressors.

         10. Patients with a total body weight < 60 kg or > 130 kg.