Phase 3 N=680 Randomized Quadruple-blind Treatment

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

Bacterial Infections

Bottom Line

View on ClinicalTrials.gov: NCT00423657 ↗

Enrolled (actual)

680

Serious AEs

4.4%

Results posted

Nov 2010

Primary outcome: Primary: Clinical Cure Rate at Test of Cure (TOC) (MITT Population) — 291; 289; 25; 28 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: ceftaroline (Drug); vancomycin plus aztreonam (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Forest Laboratories
Primary completion: Dec 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Clinical Cure Rate at Test of Cure (TOC) (MITT Population)	291; 289; 25; 28; 26; 21	—
PRIMARY The Primary Efficacy Outcome Measure Was the Per-subject Clinical Cure Rate at the TOC Visit in the Clinically Evaluable (CE) Populations.	—	—
SECONDARY To Evaluate the Microbiological Success Rate at the TOC Visit	—	—
SECONDARY To Evaluate the Clinical Response at the End of Therapy (EOT) Visit	—	—
SECONDARY To Evaluate the Clinical and Microbiological Response by Pathogen at the TOC Visit	—	—
SECONDARY To Evaluate Clinical Relapse at the Late Follow Up (LFU) Visit	—	—
SECONDARY To Evaluate Microbiological Reinfection or Recurrence at the LFU Visit	—	—
SECONDARY To Evaluate Safety	—	—

Summary

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.

Eligibility Criteria

Inclusion Criteria

Skin and skin structure infection (SSSI) that involves deeper soft tissue or requires significant surgical intervention, or cellulitis or abscess on lower extremity which occurs in subjects with diabetes mellitus or well-documented peripheral vascular disease.

Exclusion Criteria

Prior treatment of current complicated skin and skin structure infection (cSSSI) with an antimicrobial.
Failure of vancomycin or aztreonam as therapy for the current cSSSI, or prior isolation of an organism with in vitro resistance to vancomycin or aztreonam.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00423657). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.