To evaluate the pharmacokinetic (PK) profiles of ceftaroline and avibactam in adults with augmented renal clearance (ARC).
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
IV infusion of CXL (combination of ceftaroline fosamil \[600 mg\] plus avibactam \[600 mg\]) infused over 60 (± 5) minutes.
Investigational Site
Fresno, California, United States
Investigational Site
Los Angeles, California, United States
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.
Time frame: Up to 3 days
Safety and Tolerability of a Single Dose of IV Ceftaroline fosamil and Avibactam.
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.
Time frame: 24-36 hours after last study procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Investigational Site
San Diego, California, United States
Investigational Site
Stanford, California, United States
Investigational Site
Hartford, Connecticut, United States
Investigational Site
Washington D.C., District of Columbia, United States
Investigational Site
Gainesville, Florida, United States
Investigational Site
Miami, Florida, United States
Investigational Site
Chicago, Illinois, United States
Investigational Site
Maywood, Illinois, United States
...and 11 more locations