Phase 3 Completed N=698 Randomized Quadruple-blind Treatment

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

Bacterial Infections

Source: ClinicalTrials.gov NCT00424190 ↗

Enrolled (actual)

698

Serious AEs

4.0%

Results posted

Nov 2010

Primary outcomePrimary: Clinical Cure Rate at Test of Cure (TOC) (MITT Population) — 304; 297; 29; 21 participants

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Clinical Cure Rate at Test of Cure (TOC) (MITT Population)	304; 297; 29; 21; 18; 29	—
PRIMARY Clinical Cure Rate of Ceftaroline Compared With That of Vancomycin Plus Aztreonam Treatment at TOC in the Clinically Evaluable (CE) Population	—	—
SECONDARY Microbiological Success Rate at the TOC Visit	—	—
SECONDARY Clinical Response at the End of Therapy (EOT) Visit	—	—
SECONDARY Clinical and Microbiological Response by Pathogen at the TOC Visit	—	—
SECONDARY Clinical Relapse at the Late Follow Up (LFU) Visit	—	—
SECONDARY Microbiological Reinfection or Recurrence at the LFU Visit	—	—
SECONDARY Assess Safety	—	—

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 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 (NCT00424190). 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. Informational only — not medical advice.