Trial Outcomes & Findings for Efficacy and Safety of Ceftaroline Versus Linezolid in Subjects With Complicated Skin and Skin Structure Infections (NCT NCT00633152)

Results Overview

The coprimary efficacy outcome measures were the per-subject clinical cure rate at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) and (Modified-Intent-to-Treat) MITT Populations. Subjects were considered clinically cured at the Test of Cure (TOC) Visit if they had total resolution of all signs and symptoms of the baseline infection, or improvement of the infection to such an extent that no further antimicrobial therapy was necessary.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

150 participants

Primary outcome timeframe

Test of Cure Visit (8 to 15 days after end of therapy)

Results posted on

2017-03-14

Participant Flow

Twelve (12) study centers in the U.S. participated in this open label trial.

Participant milestones

Participant milestones
Measure	Ceftaroline Intramuscular every 12 hours	Linezolid Intravenous Linezolid every 12 hours (with or without Aztreonam)
Overall Study STARTED	103	47
Overall Study MITT and Safety Population	98	45
Overall Study Clinically Evaluable Population	86	39
Overall Study COMPLETED	89	41
Overall Study NOT COMPLETED	14	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Ceftaroline Intramuscular every 12 hours	Linezolid Intravenous Linezolid every 12 hours (with or without Aztreonam)
Overall Study Adverse Event	1	0
Overall Study Randomized, did not receive study drug	5	2
Overall Study Withdrawal by Subject	1	1
Overall Study Lost to Follow-up	4	1
Overall Study Miscellaneous Other	3	2

Baseline Characteristics

Efficacy and Safety of Ceftaroline Versus Linezolid in Subjects With Complicated Skin and Skin Structure Infections

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ceftaroline n=103 Participants Intramuscular every 12 hours	Linezolid n=47 Participants Intravenous Linezolid every 12 hours (with or without Aztreonam)	Total n=150 Participants Total of all reporting groups
Age, Continuous	39.6 years STANDARD_DEVIATION 12.83 • n=5 Participants	39.9 years STANDARD_DEVIATION 14.58 • n=7 Participants	39.7 years STANDARD_DEVIATION 13.36 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	18 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	70 Participants n=5 Participants	29 Participants n=7 Participants	99 Participants n=5 Participants
Region of Enrollment United States	103 participants n=5 Participants	47 participants n=7 Participants	150 participants n=5 Participants

PRIMARY outcome

Timeframe: Test of Cure Visit (8 to 15 days after end of therapy)

Population: Modified-Intent-to-Treat (MITT) Population - Any randomized subjects that received any amount of study drug

The coprimary efficacy outcome measures were the per-subject clinical cure rate at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) and (Modified-Intent-to-Treat) MITT Populations. Subjects were considered clinically cured at the Test of Cure (TOC) Visit if they had total resolution of all signs and symptoms of the baseline infection, or improvement of the infection to such an extent that no further antimicrobial therapy was necessary.

Outcome measures

Outcome measures
Measure	Ceftaroline n=98 Participants Ceftaroline was administered 600 mg as an Intramuscular injection every 12 hours	Linezolid (With or Without Aztreonam) n=45 Participants Linezolid was administered as 600 mg Intravenous infusions over 60 minutes every 12 hours
Clinical Response at the Test of Cure (TOC) Visit in the Modified Intent-to-treat (MITT) Population	84.7 percentage of participants Interval 76.0 to 91.2	88.9 percentage of participants Interval 75.9 to 96.3

PRIMARY outcome

Timeframe: Test of Cure Visit (8 to 15 Days after end of therapy)

Population: The Clinically Evaluable (CE) Population included all subjects who satisfied key minimum protocol criteria

The coprimary efficacy outcome measures were the per-subject clinical cure rate at the TOC Visit in the CE and MITT Populations. Subjects were considered clinically cured at the TOC Visit if they had total resolution of all signs and symptoms of the baseline infection, or improvement of the infection to such an extent that no further antimicrobial therapy was necessary.

Outcome measures

Outcome measures
Measure	Ceftaroline n=86 Participants Ceftaroline was administered 600 mg as an Intramuscular injection every 12 hours	Linezolid (With or Without Aztreonam) n=39 Participants Linezolid was administered as 600 mg Intravenous infusions over 60 minutes every 12 hours
Clinical Response at the Test-of-Cure (TOC) Visit in the Clinically Evaluable (CE) Population	90.7 percentage of participants Interval 82.5 to 95.9	97.4 percentage of participants Interval 86.5 to 99.9

Adverse Events

Ceftaroline

Serious events: 4 serious events

Other events: 35 other events

Deaths: 0 deaths

Linezolid

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ceftaroline n=98 participants at risk Intramuscular every 12 hours	Linezolid n=45 participants at risk Intravenous Linezolid every 12 hours (with or without Aztreonam)
Skin and subcutaneous tissue disorders Cellulitis	1.0% 1/98 • Number of events 1 • Date of First Dose of study drug to the TOC visit (AEs) or LFU visit (SAEs).	0.00% 0/45 • Date of First Dose of study drug to the TOC visit (AEs) or LFU visit (SAEs).
Skin and subcutaneous tissue disorders Necrotizing fasciitis	1.0% 1/98 • Number of events 1 • Date of First Dose of study drug to the TOC visit (AEs) or LFU visit (SAEs).	0.00% 0/45 • Date of First Dose of study drug to the TOC visit (AEs) or LFU visit (SAEs).
Skin and subcutaneous tissue disorders Postoperative wound infection	1.0% 1/98 • Number of events 1 • Date of First Dose of study drug to the TOC visit (AEs) or LFU visit (SAEs).	0.00% 0/45 • Date of First Dose of study drug to the TOC visit (AEs) or LFU visit (SAEs).
Skin and subcutaneous tissue disorders Skin infection	1.0% 1/98 • Number of events 1 • Date of First Dose of study drug to the TOC visit (AEs) or LFU visit (SAEs).	0.00% 0/45 • Date of First Dose of study drug to the TOC visit (AEs) or LFU visit (SAEs).

Other adverse events

Other adverse events
Measure	Ceftaroline n=98 participants at risk Intramuscular every 12 hours	Linezolid n=45 participants at risk Intravenous Linezolid every 12 hours (with or without Aztreonam)
Gastrointestinal disorders Nausea	12.2% 12/98 • Number of events 15 • Date of First Dose of study drug to the TOC visit (AEs) or LFU visit (SAEs).	15.6% 7/45 • Number of events 11 • Date of First Dose of study drug to the TOC visit (AEs) or LFU visit (SAEs).
Nervous system disorders Headache	10.2% 10/98 • Number of events 14 • Date of First Dose of study drug to the TOC visit (AEs) or LFU visit (SAEs).	17.8% 8/45 • Number of events 8 • Date of First Dose of study drug to the TOC visit (AEs) or LFU visit (SAEs).
Gastrointestinal disorders Diarrhea	6.1% 6/98 • Number of events 6 • Date of First Dose of study drug to the TOC visit (AEs) or LFU visit (SAEs).	8.9% 4/45 • Number of events 4 • Date of First Dose of study drug to the TOC visit (AEs) or LFU visit (SAEs).
General disorders Injection site irritation	6.1% 6/98 • Number of events 60 • Date of First Dose of study drug to the TOC visit (AEs) or LFU visit (SAEs).	0.00% 0/45 • Date of First Dose of study drug to the TOC visit (AEs) or LFU visit (SAEs).
Nervous system disorders Somnolence	6.1% 6/98 • Number of events 6 • Date of First Dose of study drug to the TOC visit (AEs) or LFU visit (SAEs).	4.4% 2/45 • Number of events 3 • Date of First Dose of study drug to the TOC visit (AEs) or LFU visit (SAEs).
Gastrointestinal disorders Vomiting	2.0% 2/98 • Number of events 2 • Date of First Dose of study drug to the TOC visit (AEs) or LFU visit (SAEs).	6.7% 3/45 • Number of events 3 • Date of First Dose of study drug to the TOC visit (AEs) or LFU visit (SAEs).
Nervous system disorders Dysgeusia	5.1% 5/98 • Number of events 5 • Date of First Dose of study drug to the TOC visit (AEs) or LFU visit (SAEs).	0.00% 0/45 • Date of First Dose of study drug to the TOC visit (AEs) or LFU visit (SAEs).

Additional Information

Vice President, Clinical Sciences

Cerexa, Inc.

Phone: 510-285-9200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place