Infection
Conditions
Keywords
PK, Pharmacokinetics
Brief summary
The purpose of this study is to determine the pharmacokinetics of ceftaroline in pediatric subjects
Detailed description
The purpose of this study is to determine the pharmacokinetics profile of ceftaroline in pediatric subjects
Interventions
DRUGceftaroline
Single parenteral infusion at a dose of 8 mg/kg for subjects weighing less than 75 kg or at a dose of 600 mg for subjects weighing greater than or equal to 75 kg infused over 60 minutes.
Sponsors
Forest Laboratories
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Hospitalized and receiving antibiotic therapy for treatment of a suspected infection of any type * Body mass index (weight \[kg\]/height squared \[m2\]) of no more than 30 * Males and females between 12 and 17 years of age, inclusive
Exclusion criteria
* History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial * Past or current history of epilepsy or seizure disorder * Critically ill or unstable patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Maximum Plasma Concentration (Cmax) of Ceftaroline After Administration of Ceftaroline Fosamil at a Dose of 8 mg/kg up to a Maximum Dose of 600 mg Via IV Infusion Over 60 Minutes. | 12 hours after infusion | The maximum plasma concentration (Cmax ) occurred around the time of the end of study drug infusion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events (AEs) Reported After Starting Study Drug Administration (Treatment Emergent Adverse Events, TEAEs) by Relationship to Ceftaroline (Related or Unrelated). | Signing of Informed Consent Form (ICF) to last follow up (FU) visit, study day 7 (+-2 days). | A TEAE is any untoward medical occurrence a subject experiences following study drug administration. Subjects were monitored for TEAEs from the start of infusion of ceftaroline fosamil on Study Day 1 through the follow-up contact on Day 7. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ceftaroline Single group assignment, single dose of 600mg ceftaroline administered intravenously. | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not receive full dose | 1 |
Baseline characteristics
| Characteristic | Ceftaroline |
|---|---|
| Age, Continuous | 13.7 years STANDARD_DEVIATION 1.8 |
| Age, Customized <=18 years | 9 participants |
| Region of Enrollment United States | 9 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 9 |
| serious Total, serious adverse events | 1 / 9 |
Outcome results
Primary
The Maximum Plasma Concentration (Cmax) of Ceftaroline After Administration of Ceftaroline Fosamil at a Dose of 8 mg/kg up to a Maximum Dose of 600 mg Via IV Infusion Over 60 Minutes.
The maximum plasma concentration (Cmax ) occurred around the time of the end of study drug infusion.
Time frame: 12 hours after infusion
Population: per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ceftaroline | The Maximum Plasma Concentration (Cmax) of Ceftaroline After Administration of Ceftaroline Fosamil at a Dose of 8 mg/kg up to a Maximum Dose of 600 mg Via IV Infusion Over 60 Minutes. | 15276 ng/mL | Standard Deviation 5997 |
Secondary
Number of Adverse Events (AEs) Reported After Starting Study Drug Administration (Treatment Emergent Adverse Events, TEAEs) by Relationship to Ceftaroline (Related or Unrelated).
A TEAE is any untoward medical occurrence a subject experiences following study drug administration. Subjects were monitored for TEAEs from the start of infusion of ceftaroline fosamil on Study Day 1 through the follow-up contact on Day 7.
Time frame: Signing of Informed Consent Form (ICF) to last follow up (FU) visit, study day 7 (+-2 days).
Population: per protocol~Out of 9 participants analyzed, 1 subject did not receive the full dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ceftaroline | Number of Adverse Events (AEs) Reported After Starting Study Drug Administration (Treatment Emergent Adverse Events, TEAEs) by Relationship to Ceftaroline (Related or Unrelated). | 8 events |