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Keep this study
Lead
Forest Laboratories
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).
Age
18–55
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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)
* 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 be 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
