Pharmacokinetic Study of Ceftaroline Fosamil/Avibactam in Adults With Augmented Renal Clearance
A Phase 1, Multicenter, Open-label, Single-dose Study to Assess the Pharmacokinetics of Ceftaroline Fosamil/Avibactam in Adults With Augmented Renal Clearance
1 other identifier
interventional
12
2 countries
21
Brief Summary
To evaluate the pharmacokinetic (PK) profiles of ceftaroline and avibactam in adults with augmented renal clearance (ARC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 2012
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 14, 2012
CompletedFirst Posted
Study publicly available on registry
June 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedApril 7, 2017
April 1, 2017
10 months
June 14, 2012
April 6, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Plasma Pharmacokinetic Parameters of Ceftaroline and Avibactam: Area under the plasma concentration versus time curve, Cmax, Tmax, T½, , CL, Vz, and Vss.
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.
Up to 3 days
Secondary Outcomes (1)
Safety and Tolerability of a Single Dose of IV Ceftaroline fosamil and Avibactam.
24-36 hours after last study procedure
Study Arms (1)
Ceftaroline fosamil/Avibactam
EXPERIMENTALInterventions
IV infusion of CXL (combination of ceftaroline fosamil \[600 mg\] plus avibactam \[600 mg\]) infused over 60 (± 5) minutes.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Investigational Site
Fresno, California, 93711, United States
Investigational Site
Los Angeles, California, 90033, United States
Investigational Site
San Diego, California, 92123, United States
Investigational Site
Stanford, California, 94605, United States
Investigational Site
Hartford, Connecticut, 06102, United States
Investigational Site
Washington D.C., District of Columbia, 20010, United States
Investigational Site
Gainesville, Florida, 32610, United States
Investigational Site
Miami, Florida, 33136, United States
Investigational Site
Chicago, Illinois, 60612, United States
Investigational Site
Maywood, Illinois, 60153, United States
Investigational Site
Peoria, Illinois, 61606, United States
Investigational Site
Duluth, Minnesota, 55805, United States
Investigational Site
Omaha, Nebraska, 68131, United States
Investigational Site
Neptune City, New Jersey, 07753, United States
Investigational Site
Winston-Salem, North Carolina, 27157, United States
Investigational Site
Cleveland, Ohio, 44106, United States
Investigational Site
Columbus, Ohio, 43210, United States
Investigational Site
Dayton, Ohio, 45409, United States
Investigational Site
Houston, Texas, 77401, United States
Investigational Site
Herston, Queensland, 4029, Australia
Investigational Site
Southport, Queensland, 4215, Australia
Related Publications (1)
Li J, Lovern M, Green ML, Chiu J, Zhou D, Comisar C, Xiong Y, Hing J, MacPherson M, Wright JG, Riccobene T, Carrothers TJ, Das S. Ceftazidime-Avibactam Population Pharmacokinetic Modeling and Pharmacodynamic Target Attainment Across Adult Indications and Patient Subgroups. Clin Transl Sci. 2019 Mar;12(2):151-163. doi: 10.1111/cts.12585. Epub 2018 Sep 28.
PMID: 30221827DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Forest Laboratories
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2012
First Posted
June 20, 2012
Study Start
May 1, 2012
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
April 7, 2017
Record last verified: 2017-04