Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT02582203
Eligibility Criteria:
Inclusion Criteria:
* Acute bacterial skin and skin structure infection (cellulitis, major abscess, surgical site infection)
* Presence of MRSA or documented risk factors for MRSA (prior antibiotic use 60 days, prior hospital exposure 180 days, skin ulcers, central venous catheter)
* Anticipating no less than two days of hospital admission
* Signed informed consent
Exclusion Criteria:
* Gas gangrene/progressive necrotizing infections
* Osteomyelitis
* Infections due to Gram-negative pathogens or other Gram-positive pathogens if S. aureus or Streptococcus is not present
* Pathogens known at the study entry to be resistant to ceftaroline or vancomycin
* Anticipated to require non-study antibiotic active against S. aureus for another reason
* Treatment for the current episode of ABSSSI for \> 24 hours with another intravenous anti-MRSA antibiotic
* Surgical (I \& D) as definitive/curative treatment
* Presence of prosthetic hardware or invasive devices suspected to be the source of infection but cannot be removed
* Life expectancy \< 2 months
* Open burn wound \> 30% total body surface area
* Pregnant or nursing mothers
* Known allergic reaction to vancomycin or ceftaroline
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
89 Years
Study:
NCT02582203
Study Brief:
Protocol Section:
NCT02582203