Pharmacokinetic Study of Ceftaroline Fosamil/Avibactam in Adults With Augmented Renal Clearance (NCT01624246) | Clinical Trial Compass
CompletedPhase 1
Pharmacokinetic Study of Ceftaroline Fosamil/Avibactam in Adults With Augmented Renal Clearance
United States12 participantsStarted 2012-05
Plain-language summary
To evaluate the pharmacokinetic (PK) profiles of ceftaroline and avibactam in adults with augmented renal clearance (ARC).
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 femal…
What they're measuring
1
Plasma Pharmacokinetic Parameters of Ceftaroline and Avibactam: Area under the plasma concentration versus time curve, Cmax, Tmax, T½, , CL, Vz, and Vss.