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:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-25 @ 3:39 AM
NCT ID:
NCT02066402
Eligibility Criteria:
Inclusion Criteria:
* Males or females \>/=18 years old
* Adequate venous access for a minimum of 2 I.V. doses of study drug
* Acute Bacterial Skin and skin structure infection (ABSSSI) meeting at least 1 of the clinical syndrome definitions listed below and requiring I.V. antibiotic therapy. Local symptoms must have started within 7 days before the Screening Visit
* Cellulitis/erysipelas
* Major cutaneous abscess
* Wound Infection
* Suspected or documented gram-positive infection from baseline Gram stain or culture.
Exclusion Criteria:
* Uncomplicated skin and skin structure infections such as furuncles, minor abscesses
* Infections associated with, or in close proximity to, a prosthetic device
* Severe sepsis or septic shock
* Known bacteremia at time of screening
* ABSSSI due to or associated with any of the following:
* Suspected or documented gram-negative pathogens in patients with cellulitis/erysipelas or major cutaneous abscess that require an antibiotic with specific gram-negative coverage. Patients with wound infections where gram-negative adjunctive therapy is warranted may be enrolled if they meet the other eligibility criteria
* Diabetic foot infections, gangrene, or perianal abscess
* Concomitant infection at another site not including a secondary ABSSSI lesion (eg, septic arthritis, endocarditis, osteomyelitis)
* Infected burns
* Decubitus or chronic skin ulcer, or ischemic ulcer due to peripheral vascular disease (arterial or venous)
* Any evolving necrotizing process (ie, necrotizing fasciitis)
* Use of antibiotics as follows:
* Systemic antibiotic with gram-positive cocci activity for the treatment of any infection within 24 hours before the first infusion of study drug
* Patients who failed prior therapy for the primary infection site are also excluded from enrollment
* Topical antibiotic on the primary lesion within 24 hours before the first infusion of study drug except for antibiotic/antiseptic-coated dressing applied to the clean postsurgical wound
* Administration of Linezolid within 30 days before the first infusion of the study drug
* Recent history of opportunistic infections where the underlying cause of these infections is still active (eg, leukemia, transplant, acquired immunodeficiency syndrome \[AIDS\])
* Previous exposure to Tedizolid Phosphate treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02066402
Study Brief:
Protocol Section:
NCT02066402