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

Completed · Phase 1

Conditions studied: Augmented Renal Clearance (ARC), Systemic Inflammatory Response Syndrome (SIRS)

In brief

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

Key facts

Study ID

NCT01624246

Run by

Forest Laboratories

People needed

12

Starts

2012-05-01

Expected to finish

2013-03-01

Last updated by the study team

2017-04-07

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Investigational Site — Fresno, California, United States
• Investigational Site — Los Angeles, California, United States
• 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
• Investigational Site — Peoria, Illinois, United States
• Investigational Site — Duluth, Minnesota, United States
• Investigational Site — Omaha, Nebraska, United States
• Investigational Site — Neptune City, New Jersey, United States
• Investigational Site — Winston-Salem, North Carolina, United States
• Investigational Site — Cleveland, Ohio, United States
• Investigational Site — Columbus, Ohio, United States
• Investigational Site — Dayton, Ohio, United States
• Investigational Site — Houston, Texas, United States
• Investigational Site — Herston, Queensland, Australia
• Investigational Site — Southport, Queensland, Australia

Full record on ClinicalTrials.gov

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