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Pharmacokinetic Study of Ceftaroline Fosamil/Avibactam in Adults With Augmented Renal Clearance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cerexa, Inc.
ClinicalTrials.gov Identifier:
NCT01624246
First received: June 14, 2012
Last updated: October 11, 2013
Last verified: October 2013
  Purpose

To evaluate the pharmacokinetic (PK) profiles of ceftaroline and avibactam in adults with augmented renal clearance (ARC).


Condition Intervention Phase
Augmented Renal Clearance (ARC)
Systemic Inflammatory Response Syndrome (SIRS)
Drug: Ceftaroline fosamil/Avibactam (CXL)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Multicenter, Open-label, Single-dose Study to Assess the Pharmacokinetics of Ceftaroline Fosamil/Avibactam in Adults With Augmented Renal Clearance

Resource links provided by NLM:


Further study details as provided by Cerexa, Inc.:

Primary Outcome Measures:
  • Plasma Pharmacokinetic Parameters of Ceftaroline and Avibactam: Area under the plasma concentration versus time curve, Cmax, Tmax, T½, , CL, Vz, and Vss. [ Time Frame: Up to 3 days ] [ Designated as safety issue: No ]
    The following PK parameters, if calculable, will be determined for ceftaroline, ceftaroline fosamil, ceftaroline M-1, and avibactam: area under the plasma concentration versus time curve, Cmax, time of maximum plasma drug concentration (Tmax), T½, apparent total body clearance of drug from plasma (CL), apparent volume of distribution during the terminal phase (Vz), and Vss.


Secondary Outcome Measures:
  • Safety and Tolerability of a Single Dose of IV Ceftaroline fosamil and Avibactam. [ Time Frame: 24-36 hours after last study procedure ] [ Designated as safety issue: Yes ]
    Adverse events will be summarized. Vital signs (pulse, blood pressure, respiratory rate, temperature), oxygen saturation and concomitant medications will be summarized. Complete blood count (CBC) and comprehensive metabolic panel results will be summarized.


Estimated Enrollment: 24
Study Start Date: May 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ceftaroline fosamil/Avibactam Drug: Ceftaroline fosamil/Avibactam (CXL)
IV infusion of CXL (combination of ceftaroline fosamil [600 mg] plus avibactam [600 mg]) infused over 60 (± 5) minutes.

Detailed Description:

To evaluate the single-dose pharmacokinetic (PK) profiles of ceftaroline and avibactam following intravenous (IV) administration of ceftaroline fosamil/avibactam ("CXL") in adults with augmented renal clearance (ARC).

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female adults ≥ 18 and ≤ 55 years old
  • Augmented renal clearance, defined as:

    • Estimated CrCl ≥ 115 mL/min (calculated using modified Cockcroft-Gault, before the measured 8-hour urine collection)
    • Measured CrCl ≥ 140 mL/min (from an 8-hour urine collection)
  • Hospitalized and diagnosed with SIRS, defined by at least 2 of the following:

    • Temperature (oral, rectal, tympanic, or core) > 38.5°C or < 35.0°C
    • Heart rate > 90 beats/min
    • Respiratory rate > 20 breaths/min or PaCO2 < 32 mmHg
    • Leukocytosis (> 12,000 white blood cells [WBC]/mm3), leukopenia (< 4000 WBC/mm3), or bandemia (> 10% immature neutrophils [bands] regardless of total peripheral WBC)
  • Requires indwelling urinary bladder catheter per standard of care (through the end of the 8-hour urine collection)

Exclusion Criteria:

  • History of any known hypersensitivity or allergic reaction to cephalosporins or any β-lactam antimicrobial (eg, penicillins)
  • History of chronic kidney disease, hemodialysis, or peritoneal dialysis; or history of acute renal replacement therapy (eg, hemodialysis, hemofiltration) associated with current illness
  • Suspected rhabdomyolysis or creatine kinase > 10,000 U/L
  • Significant anemia defined as hemoglobin < 9 g/dL or hematocrit < 27%
  • Transfusion of packed red blood cells (PRBC) or whole blood within 24 hours of study drug infusion or anticipated need for a transfusion before the last PK blood sample is collected
  • If female, currently pregnant or breastfeeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01624246

Locations
United States, California
Investigational Site
Fresno, California, United States, 93711
Investigational Site
Los Angeles, California, United States, 90033
Investigational Site
San Diego, California, United States, 92123
Investigational Site
Stanford, California, United States, 94605
United States, Connecticut
Investigational Site
Hartford, Connecticut, United States, 06102
United States, District of Columbia
Investigational Site
Washington, District of Columbia, United States, 20010
United States, Florida
Investigational Site
Gainesville, Florida, United States, 32610
Investigational Site
Miami, Florida, United States, 33136
United States, Illinois
Investigational Site
Chicago, Illinois, United States, 60612
Investigational Site
Maywood, Illinois, United States, 60153
Investigational Site
Peoria, Illinois, United States, 61606
United States, Minnesota
Investigational Site
Duluth, Minnesota, United States, 55805
United States, Nebraska
Investigational Site
Omaha, Nebraska, United States, 68131
United States, New Jersey
Investigational Site
Neptune, New Jersey, United States, 07753
United States, North Carolina
Investigational Site
Winston Salem, North Carolina, United States, 27157
United States, Ohio
Investigational Site
Cleveland, Ohio, United States, 44106
Investigational Site
Columbus, Ohio, United States, 43210
Investigational Site
Dayton, Ohio, United States, 45409
United States, Texas
Investigational Site
Houston, Texas, United States, 77401
Australia, Queensland
Investigational Site
Herston, Queensland, Australia, 4029
Investigational Site
Southport, Queensland, Australia, 4215
Sponsors and Collaborators
Cerexa, Inc.
Investigators
Study Director: Medical Monitor Cerexa, Inc.
  More Information

No publications provided

Responsible Party: Cerexa, Inc.
ClinicalTrials.gov Identifier: NCT01624246     History of Changes
Other Study ID Numbers: CXL-PK-04
Study First Received: June 14, 2012
Last Updated: October 11, 2013
Health Authority: United States: Food and Drug Administration
Australia: Therapeutic Goods Administration

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock

ClinicalTrials.gov processed this record on November 20, 2014