Phase 3
Completed N=761
Evaluation of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections
Complicated Skin and Soft Tissue Infection
Source: ClinicalTrials.gov NCT01499277 ↗
Enrolled (actual)
761
Serious AEs
6.0%
Results posted
Nov 2015
Primary outcomePrimary: Clinical Response at Test of Cure (TOC) in Modified Intent-to-treat (MITT) Analysis Set — 396; 202; 58; 34 Participant
Summary
The purpose of this study is to evaluate the effects of Ceftaroline Fosamil versus Vancomycin plus Aztreonam in treatment of patients with complicated bacterial skin and soft tissue infections.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Response at Test of Cure (TOC) in Modified Intent-to-treat (MITT) Analysis Set |
396; 202; 58; 34; 52; 19 | — |
| PRIMARY Clinical Response at TOC in Clinically Evaluable (CE) Analysis Set |
342; 180; 53; 31 | — |
| SECONDARY Per Patient Microbiological Response at TOC in Microbiologically Modified-intent-to-treat (mMITT) Analysis Set |
203; 109; 17; 17; 28; 10 | — |
| SECONDARY Per-patient Micro Response at TOC in Microbiologically Evaluable (ME) Analysis Set |
167; 98; 14; 14 | — |
| SECONDARY Clinical Response at End of Treatment (EOT) in MITT Analysis Set |
429; 213; 44; 29; 31; 11 | — |
| SECONDARY Clinical Response at EOT in CE Analysis Set |
356; 184; 39; 27 | — |
| SECONDARY Clinical Relapse at Late Follow-up (LFU) in CE Patients Who Were Cured at TOC |
3; 3; 335; 174; 3; 3 | — |
| SECONDARY Early Response at 48 to 72 Hours of Treatment in MITT Analysis Set |
445; 229; 28; 11; 33; 15 | — |
| SECONDARY Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME |
91; 49; 3; 8; 22; 12 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female, aged 18 years or older
- Complicated skin and skin structure infection (cSSTI)
- Infection of sufficient severity to warrant hospitalization
- Infection of sufficient severity such that it is expected to require at least 5 days of intravenous antibiotic therapy
Exclusion Criteria
- Received systemic antibacterial drugs for greater than 24 hours within 96 hours prior to first dose of study drug
- Uncomplicated skin and skin structure infections, skin infections suspected to be caused by viral or fungal pathogens
- Diabetic foot infections, decubitus ulcers, ulcers due to peripheral vascular disease
- Infection caused by human or animal bites, sternal wound infections, bone infection or arthritis due to an infection, critical limb ischemia of the affected limb
- Chronic liver disease or severe impaired renal function, severe low white blood cell count, burns on greater than 15% of total body surface area, necrotizing skin infection, amputation required of primary site of infection, sustained shock
Data sourced from ClinicalTrials.gov (NCT01499277). 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.