Trial Outcomes & Findings for Pharmacokinetics of Ceftaroline in Subjects 12 to 17 Years of Age (NCT NCT00633126)

NCT ID: NCT00633126

Last Updated: 2017-03-14

Results Overview

The maximum plasma concentration (Cmax ) occurred around the time of the end of study drug infusion.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 9 participants
• Primary outcome timeframe: 12 hours after infusion
• Results posted on: 2017-03-14

Participant Flow

Participant milestones

Measure	Ceftaroline Single group assignment, single dose of 600mg ceftaroline administered intravenously.
Overall Study STARTED	9
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Ceftaroline Single group assignment, single dose of 600mg ceftaroline administered intravenously.
Overall Study Did not receive full dose	1

Baseline Characteristics

Pharmacokinetics of Ceftaroline in Subjects 12 to 17 Years of Age

Baseline characteristics by cohort

Measure	Ceftaroline n=9 Participants Single group assignment, single dose of 600mg ceftaroline administered intravenously.
Age, Continuous	13.7 years STANDARD_DEVIATION 1.80 • n=5 Participants
Age, Customized <=18 years	9 participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 hours after infusion

Population: per protocol

The maximum plasma concentration (Cmax ) occurred around the time of the end of study drug infusion.

Outcome measures

Measure	Ceftaroline n=8 Participants Single group assignment, single dose of 600mg ceftaroline administered intravenously.
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 outcome

Timeframe: 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.

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.

Outcome measures

Measure	Ceftaroline n=9 Participants Single group assignment, single dose of 600mg ceftaroline administered intravenously.
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

Adverse Events

Ceftaroline

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ceftaroline n=9 participants at risk Single group assignment, single dose of 600mg ceftaroline administered intravenously.
Musculoskeletal and connective tissue disorders Pathological fracture	11.1% 1/9 • Number of events 1 • AEs were evaluated from the start of study drug infusion to last FU visit, study day 7 (+-2 days). Serious Adverse Events (SAEs) were evaluated through 30 days after the Ceftaroline infusion.

Other adverse events

Measure	Ceftaroline n=9 participants at risk Single group assignment, single dose of 600mg ceftaroline administered intravenously.
Gastrointestinal disorders Vomiting	11.1% 1/9 • Number of events 1 • AEs were evaluated from the start of study drug infusion to last FU visit, study day 7 (+-2 days). Serious Adverse Events (SAEs) were evaluated through 30 days after the Ceftaroline infusion.
Cardiac disorders Extrasystoles	11.1% 1/9 • Number of events 1 • AEs were evaluated from the start of study drug infusion to last FU visit, study day 7 (+-2 days). Serious Adverse Events (SAEs) were evaluated through 30 days after the Ceftaroline infusion.
Gastrointestinal disorders Constipation	11.1% 1/9 • Number of events 1 • AEs were evaluated from the start of study drug infusion to last FU visit, study day 7 (+-2 days). Serious Adverse Events (SAEs) were evaluated through 30 days after the Ceftaroline infusion.
General disorders Infusion site extravasation	11.1% 1/9 • Number of events 1 • AEs were evaluated from the start of study drug infusion to last FU visit, study day 7 (+-2 days). Serious Adverse Events (SAEs) were evaluated through 30 days after the Ceftaroline infusion.
Investigations ECG Prolonged QT	11.1% 1/9 • Number of events 1 • AEs were evaluated from the start of study drug infusion to last FU visit, study day 7 (+-2 days). Serious Adverse Events (SAEs) were evaluated through 30 days after the Ceftaroline infusion.
Musculoskeletal and connective tissue disorders Arthralgia	11.1% 1/9 • Number of events 1 • AEs were evaluated from the start of study drug infusion to last FU visit, study day 7 (+-2 days). Serious Adverse Events (SAEs) were evaluated through 30 days after the Ceftaroline infusion.
Respiratory, thoracic and mediastinal disorders Nasal dryness	11.1% 1/9 • Number of events 1 • AEs were evaluated from the start of study drug infusion to last FU visit, study day 7 (+-2 days). Serious Adverse Events (SAEs) were evaluated through 30 days after the Ceftaroline infusion.

Additional Information

David Friedland, MD

Cerexa, Inc.

Phone: 510-285-9200

Email: clinicaltrials@cerexa.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place