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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
NA
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01624246