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

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories
• Treatments: Avibactam; Ceftaroline fosamil; Cephalosporins

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