Phase 3
N=698
Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections
Bacterial Infections
Bottom Line
View on ClinicalTrials.gov: NCT00424190 ↗Enrolled (actual)
698
Serious AEs
4.0%
Results posted
Nov 2010
Primary outcome: Primary: Clinical Cure Rate at Test of Cure (TOC) (MITT Population) — 304; 297; 29; 21 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- IV Vancomycin plus IV Aztreonam (Drug); Ceftaroline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Forest Laboratories
- Primary completion
- Nov 2007
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 |
— | — |
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 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.
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.