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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01624246




Registration number
NCT01624246
Ethics application status
Date submitted
14/06/2012
Date registered
20/06/2012
Date last updated
7/04/2017

Titles & IDs
Public title
Pharmacokinetic Study of Ceftaroline Fosamil/Avibactam in Adults With Augmented Renal Clearance
Scientific title
A Phase 1, Multicenter, Open-label, Single-dose Study to Assess the Pharmacokinetics of Ceftaroline Fosamil/Avibactam in Adults With Augmented Renal Clearance
Secondary ID [1] 0 0
CXL-PK-04
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Augmented Renal Clearance (ARC) 0 0
Systemic Inflammatory Response Syndrome (SIRS) 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ceftaroline fosamil/Avibactam (CXL)

Experimental: Ceftaroline fosamil/Avibactam -


Treatment: Drugs: Ceftaroline fosamil/Avibactam (CXL)
IV infusion of CXL (combination of ceftaroline fosamil [600 mg] plus avibactam [600 mg]) infused over 60 (± 5) minutes.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Plasma Pharmacokinetic Parameters of Ceftaroline and Avibactam: Area under the plasma concentration versus time curve, Cmax, Tmax, T½, , CL, Vz, and Vss.
Timepoint [1] 0 0
Up to 3 days
Secondary outcome [1] 0 0
Safety and Tolerability of a Single Dose of IV Ceftaroline fosamil and Avibactam.
Timepoint [1] 0 0
24-36 hours after last study procedure

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- History of any known hypersensitivity or allergic reaction to cephalosporins or any
ß-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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2013
Sample size
Target
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Investigational Site - Herston
Recruitment hospital [2] 0 0
Investigational Site - Southport
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
4215 - Southport
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
Nebraska
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Forest Laboratories
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To evaluate the pharmacokinetic (PK) profiles of ceftaroline and avibactam in adults with
augmented renal clearance (ARC).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01624246
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Forest Laboratories
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01624246