Pharmacokinetic Study of Ceftaroline Fosamil/Avibactam in Adults With Augmented Renal Clearance
This study is currently recruiting participants.
Verified January 2013 by Cerexa, Inc.
Sponsor:
Cerexa, Inc.
Information provided by (Responsible Party):
Cerexa, Inc.
ClinicalTrials.gov Identifier:
NCT01624246
First received: June 14, 2012
Last updated: January 16, 2013
Last verified: January 2013
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Purpose
To evaluate the pharmacokinetic (PK) profiles of ceftaroline and avibactam in adults with augmented renal clearance (ARC).
| Condition | Intervention | Phase |
|---|---|---|
|
Augmented Renal Clearance (ARC) Systemic Inflammatory Response Syndrome (SIRS) |
Drug: Ceftaroline fosamil/Avibactam (CXL) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1, Multicenter, Open-label, Single-dose Study to Assess the Pharmacokinetics of Ceftaroline Fosamil/Avibactam in Adults With Augmented Renal Clearance |
Resource links provided by NLM:
Further study details as provided by Cerexa, Inc.:
Primary Outcome Measures:
- Plasma Pharmacokinetic Parameters of Ceftaroline and Avibactam: Area under the plasma concentration versus time curve, Cmax, Tmax, T½, , CL, Vz, and Vss. [ Time Frame: Up to 3 days ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Safety and Tolerability of a Single Dose of IV Ceftaroline fosamil and Avibactam. [ Time Frame: 24-36 hours after last study procedure ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 24 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Ceftaroline fosamil/Avibactam |
Drug: Ceftaroline fosamil/Avibactam (CXL)
IV infusion of CXL (combination of ceftaroline fosamil [600 mg] plus avibactam [600 mg]) infused over 60 (± 5) minutes.
|
Detailed Description:
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).
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01624246
Contacts
| Contact: Cerexa Trial Coordinator | 510-285-9200 | clinicaltrials@cerexa.com |
Locations
| United States, California | |
| Investigational Site | Recruiting |
| Fresno, California, United States, 93711 | |
| Investigational Site | Recruiting |
| Los Angeles, California, United States, 90033 | |
| Investigational Site | Recruiting |
| San Diego, California, United States, 92123 | |
| Investigational Site | Recruiting |
| Stanford, California, United States, 94605 | |
| United States, Connecticut | |
| Investigational Site | Recruiting |
| Hartford, Connecticut, United States, 06102 | |
| United States, District of Columbia | |
| Investigational Site | Recruiting |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| Investigational Site | Recruiting |
| Gainesville, Florida, United States, 32610 | |
| Investigational Site | Recruiting |
| Miami, Florida, United States, 33136 | |
| United States, Illinois | |
| Investigational Site | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Investigational Site | Recruiting |
| Maywood, Illinois, United States, 60153 | |
| Investigational Site | Recruiting |
| Peoria, Illinois, United States, 61606 | |
| United States, Minnesota | |
| Investigational Site | Recruiting |
| Duluth, Minnesota, United States, 55805 | |
| United States, Nebraska | |
| Investigational Site | Recruiting |
| Omaha, Nebraska, United States, 68131 | |
| United States, New Jersey | |
| Investigational Site | Recruiting |
| Neptune, New Jersey, United States, 07753 | |
| United States, North Carolina | |
| Investigational Site | Recruiting |
| Winston Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| Investigational Site | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Investigational Site | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Investigational Site | Recruiting |
| Dayton, Ohio, United States, 45409 | |
| United States, Texas | |
| Investigational Site | Recruiting |
| Houston, Texas, United States, 77401 | |
| Australia, Queensland | |
| Investigational Site | Recruiting |
| Herston, Queensland, Australia, 4029 | |
| Investigational Site | Recruiting |
| Southport, Queensland, Australia, 4215 | |
Sponsors and Collaborators
Cerexa, Inc.
Investigators
| Study Director: | Medical Monitor | Cerexa, Inc. |
More Information
No publications provided
| Responsible Party: | Cerexa, Inc. |
| ClinicalTrials.gov Identifier: | NCT01624246 History of Changes |
| Other Study ID Numbers: | CXL-PK-04 |
| Study First Received: | June 14, 2012 |
| Last Updated: | January 16, 2013 |
| Health Authority: | United States: Food and Drug Administration Australia: Therapeutic Goods Administration |
Additional relevant MeSH terms:
|
Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Shock |
ClinicalTrials.gov processed this record on May 23, 2013