Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections (cSSSI)

This study has been completed.

Sponsor:

Information provided by:

Cerexa, Inc.

ClinicalTrials.gov Identifier:

NCT00424190

First received: January 16, 2007

Last updated: November 23, 2010

Last verified: November 2010

History of Changes

Results First Received: October 12, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Bacterial Infections
Interventions:	Drug: IV Vancomycin plus IV Aztreonam Drug: Ceftaroline

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited worldwide from February 2007 to November 2007

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were screened for up to 24 hours

Reporting Groups

	Description
Ceftaroline Fosamil for Injection	Ceftaroline fosamil 600 mg administered IV over 60 minutes every 12 hours followed by placebo administered over 60 minutes every 12 hours
IV Vancomycin Plus IV Aztreonam	Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours

Participant Flow: Overall Study

	Ceftaroline Fosamil for Injection	IV Vancomycin Plus IV Aztreonam
STARTED	351	347
COMPLETED	329	317
NOT COMPLETED	22	30
Withdrew consent	3	4
Death	3	0
Noncompliance	1	2
Request of sponsor or investigator	0	2
Diagnosis of osteomyelitis	0	1
Other	15	21

Baseline Characteristics

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Reporting Groups

	Description
Ceftaroline Fosamil for Injection	Ceftaroline fosamil 600 mg administered IV over 60 minutes every 12 hours followed by placebo administered over 60 minutes every 12 hours
IV Vancomycin Plus IV Aztreonam	Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours
Total	Total of all reporting groups

Baseline Measures

	Ceftaroline Fosamil for Injection	IV Vancomycin Plus IV Aztreonam	Total
Number of Participants [units: participants]	351	347	698
Age [units: years] Mean ± Standard Deviation	49.2 ± 17.17	47.2 ± 17.01	48.2 ± 17.10
Age, Customized [units: participants]
>=65 years	57	72	129
<18 years	0	0	0
>=18 years and < 65 years	294	275	569
Gender [units: participants]
Female	131	129	260
Male	220	218	438
Race/Ethnicity, Customized [units: participants]
Non-Hispanic	268	270	538
Hispanic	83	77	160

Outcome Measures

1. Primary:

Clinical Cure Rate at Test of Cure (MITT Population) [ Time Frame: 8-15 days after the end of treatment ]

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2. Primary:

Clinical Cure Rate of Ceftaroline Compared With That of Vancomycin Plus Aztreonam Treatment at TOC in the Clinically Evaluable (CE) Population [ Time Frame: 8-15 days after last dose of study drug ]