Open Fractures
Conditions
Brief summary
Prospective look at antibiotic prophylaxis with Ceftaroline in patients with type II and III open fractures
Detailed description
Determine if antibiotic prophylaxis with Ceftaroline in patients with type II and III open fractures is a safe and effective alternative to standard combination therapy
Interventions
DRUGCeftaroline
IV Ceftaroline will be given for 72 hours
Sponsors
Forest Laboratories
Olayemi Osiyemi MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* male or female \>= 18 years old * complete an informed consent * patients are diagnosed with a type II or III open fracture
Exclusion criteria
* allergy to beta-lactam antibiotics prior to screening * prior to enrollment: patients received 3 or more doses of antibiotic prophylaxis * pregnant female * inability to provide consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of fracture site infection at 30 days between ceftaroline and historical hospital rate | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of acute kidney injury | 30 days |
Other
| Measure | Time frame |
|---|---|
| Identify bacteria associated with the infections | 30 days |
| identify the number of infections associated with sites other than fracture site | 30 days |
Countries
United States
Contacts
Primary ContactPaul Glickman
Backup ContactOlayemi Osiyemi, MD
Outcome results
None listed