Complicated Skin and Soft Tissue Infection
Conditions
Keywords
complicated skin and soft tissue infections (cSSTI), skin infection, ceftaroline, wound infection, cellulitis, burn infection, bacterial infection, vancomycin
Brief 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.
Detailed description
A Phase III, Multicentre, Randomised, Double-Blind Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600 mg every 8 hours) Versus Vancomycin Plus Aztreonam in the Treatment of Patients with Complicated Bacterial Skin and Soft Tissue Infections With Evidence of Systemic Inflammatory Response or Underlying Comorbidities
Interventions
IV ceftaroline 600mg every 8 hours
DRUGVancomycin
IV vancomycin 15mg/kg every 12 hours
DRUGAztreonam
IV aztreonam 1 g every 8 hours
Sponsors
Forest Laboratories
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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. patients must have a positive culture for MRSA that has been obtained from the skin infection site and/or blood samples at any time within the 72hrs before the first dose.
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Response at TOC | 7 to 20 days after last dose of study drug | Clinical cure is defined as resolution or improvement of signs and symptoms compared to baseline and no further antimicrobial therapy is necessary. Clinical failure is defined as any of the following: persistence or worsening in signs or symptoms, or requirement for concomitant antibiotic therapy, or requirement of an unplanned surgical intervention \>48 hours after the first dose, or death caused by skin infection, or an AE leading to study drug discontinuation with alternative antimicrobial therapy required, or diagnosis of osteomyelitis \>=8 days after the first dose. |
Countries
Argentina, Brazil, Bulgaria, Chile, Croatia, Greece, Israel, Italy, Poland, Romania, South Africa, Spain, Turkey (Türkiye)
Participant flow
Recruitment details
Overall, 4 patients were enrolled from 2 centres in 1 regions in this study. The first patient was enrolled on 15 September 2014 and the last patient last visit was on 02 January 2015.
Participants by arm
| Arm | Count |
|---|---|
| Ceftaroline Ceftaroline fosamil 600 mg 120 min | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | Ceftaroline |
|---|---|
| Age, Continuous | 80.25 years STANDARD_DEVIATION 4.875 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 4 |
| serious Total, serious adverse events | 1 / 4 |
Outcome results
Primary
Clinical Response at TOC
Clinical cure is defined as resolution or improvement of signs and symptoms compared to baseline and no further antimicrobial therapy is necessary. Clinical failure is defined as any of the following: persistence or worsening in signs or symptoms, or requirement for concomitant antibiotic therapy, or requirement of an unplanned surgical intervention \>48 hours after the first dose, or death caused by skin infection, or an AE leading to study drug discontinuation with alternative antimicrobial therapy required, or diagnosis of osteomyelitis \>=8 days after the first dose.
Time frame: 7 to 20 days after last dose of study drug
Population: Randomized
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftaroline | Clinical Response at TOC | Clinical cure | 3 Participant |
| Ceftaroline | Clinical Response at TOC | Clinical failure | 0 Participant |
| Ceftaroline | Clinical Response at TOC | Indeterminate | 1 Participant |