Study of Blood Levels of Ceftaroline Fosamil in Children Who Are Receiving Antibiotic Therapy in the Hospital

This study has been completed.

Sponsor:

Collaborator:

Forest Laboratories

Information provided by (Responsible Party):

Cerexa, Inc.

ClinicalTrials.gov Identifier:

NCT01298843

First received: February 15, 2011

Last updated: March 1, 2013

Last verified: March 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	February 15, 2011
Last Updated Date	March 1, 2013
Start Date ^ICMJE	April 2011
Primary Completion Date	February 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 14, 2011)	Pharmacokinetic profile of Ceftaroline fosamil, plasma concentrations time profile of ceftaroline fosamil by patient, age cohort and dosage level, and Safety and tolerability of ceftaroline fosamil following a single dose of ceftaroline. [ Time Frame: Up to 5 days ] [ Designated as safety issue: Yes ] This study has 3 primary outcome measures: plasma concentration of ceftaroline fosamil and its metabolites from blood samples after a single dose; PK profile of ceftaroline, and safety, where number of subjects with serious and non-serious adverse events and type of frequency of adverse events will be reported.
Original Primary Outcome Measures ^ICMJE (submitted: February 16, 2011)	2. To evaluate plasma concentrations - time profile of ceftaroline fosamil by patient, age cohort and dosage level. [ Time Frame: up to 5 days ] [ Designated as safety issue: Yes ] Plasma concentration of ceftaroline fosamil and its metabolites from blood samples will be evaluated, PK profile will be characterized, and adverse events and safety laboratory parameters will be monitored and analyzed in safety population. 1. To evaluate the single-dose pharmacokinetic profile of ceftaroline fosamil. [ Time Frame: Up to 5 days ] [ Designated as safety issue: Yes ] Plasma concentration of ceftaroline fosamil and its metabolites from blood samples will be evaluated, PK profile will be characterized, and adverse events and safety laboratory parameters will be monitored and analyzed in safety population. 3. To evaluate safety and tolerability of ceftaroline fosamil following a single dose. [ Time Frame: Up to 5 days ] [ Designated as safety issue: Yes ] Plasma concentration of ceftaroline fosamil and its metabolites from blood samples will be evaluated, PK profile will be characterized, and adverse events and safety laboratory parameters will be monitored and analyzed in safety population.
Change History	Complete list of historical versions of study NCT01298843 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of Blood Levels of Ceftaroline Fosamil in Children Who Are Receiving Antibiotic Therapy in the Hospital
Official Title ^ICMJE	Pharmacokinetics of a Single Dose of Ceftaroline Fosamil in Children Ages Birth to Younger Than 12 Years With Suspected or Confirmed Infection
Brief Summary	The purpose of this study is to assess blood levels of Ceftaroline fosamil in children.
Detailed Description	To characterize single dose pharmacokinetics of Ceftaroline fosamil in children.
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label
Condition ^ICMJE	Infections
Intervention ^ICMJE	Drug: Ceftaroline fosamil Single dose of 15 mg/kg (up to 600 mg) by intravenous infusion
Study Arm (s)	Study of Blood Levels of Ceftaroline Fosamil Study of Blood Levels of Ceftaroline Fosamil in Children Who Are Receiving Antibiotic Therapy in the Hospital Intervention: Drug: Ceftaroline fosamil
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	53
Completion Date	February 2013
Primary Completion Date	February 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Subjects must meet the following inclusion criteria: Male or female children with ages from birth to younger than 12 years Hospitalized and receiving systemic antibiotic therapy for treatment of a suspected or confirmed infection Sufficient intravascular access Negative urine pregnancy test Written informed consent from parent(s)and verbal informed assent from subject Exclusion Criteria: Subjects must NOT meet any of the following exclusion criteria: History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial Past or current history of epilepsy or seizure disorder Moderate or severe renal impairment If female, currently pregnant or nursing Aspartate aminotransferase, alanine aminotransferase, or total bilirubin level > 3 times upper limit of normal Any condition that would make the subject, in the opinion of the Investigator, unsuitable for the study Use of probenecid within 3 days prior to dosing Receipt of a blood transfusion during the 24-hour period before enrollment
Gender	Both
Ages	up to 11 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01298843
Other Study ID Numbers ^ICMJE	P903-21
Has Data Monitoring Committee	Yes
Responsible Party	Cerexa, Inc.
Study Sponsor ^ICMJE	Cerexa, Inc.
Collaborators ^ICMJE	Forest Laboratories
Investigators ^ICMJE	Not Provided
Information Provided By	Cerexa, Inc.
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top