Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 2, Randomized, Double-blind, Multi-center Study to Evaluate the Safety and Efficacy of CEM-102 Compared to Linezolid in the Treatment of Acute Bacterial Skin Structure Infections
Brief Summary: The purpose of this study is to determine the safety and efficacy of CEM-102 compared to Linezolid in the treatment of acute bacterial skin structure infections (ABSSIs).


Options:
A: Inclusion Criteria:

* Patients with systemic signs of infection diagnosed with acute bacterial skin and skin structure infection (ABSSSI)
* Diagnosed with Cellulitis/ erysipelas, major cutaneous abscess, or wound infections

Exclusion Criteria:

* Uncomplicated skin infections
* Severe sepsis or septic shock
* ABSSSI solely due to gram-negative pathogens
B: Inclusion Criteria

* Complicated skin and skin structure infection, presumed or proven to be caused by gram-positive pathogen(s).
* Patients, ages 18 years and older, must not be below normal body weight or morbidly obese.
* Female patients must not be pregnant at time of enrollment and must agree to a reliable method of birth control during the study and for 6 months following the last dose of study drug.

Exclusion Criteria:

Patients:

* with a condition which would prevent performing protocol safety and efficacy assessments.
* who have received antibiotics for more than 24 hours within the last 3 days.
* with an infection involving deep tissues or unlikely to be caused by gram positive bacteria
* who are nursing and will not stop nursing for at least 6 months
* with a prior allergic reaction to glycopeptides (e.g. vancomycin)
* with any of the following:

  1. toxic shock syndrome or toxic-like syndrome
  2. presumed or proven infection caused by Clostridium species
  3. bone infections
  4. ischemic or gangrenous ulcers or wounds
  5. infections caused only by gram-negative bacteria
  6. infection of an artificial joint that cannot be removed
  7. infection of the scrotum, perineum or perianal region
  8. infection of a severe burn wound
  9. severe ear infection involving bone and/or cartilage
  10. infection following injury in water possibly containing Vibrio species or following a history of eating raw oysters within 1 week prior to disease onset
C: Inclusion Criteria:

* Type 1 or 2 Diabetes Mellitus treated with diet or medication
* Clinically or microbiologically documented foot infection below the knee
* Osteomyelitic bone must be removed within 48 hours of study entry

Exclusion Criteria:

* Uncomplicated skin infections
* Infected burn wounds
* Necrotizing fascitis
* Wounds with gangrene that cannot be removed with debridement
* Infections of prosthetic materials
* Foreign materials that can not be removed by surgical debridement
* Patients with another antibiotic 3 days prior to enrollment without evidence of treatment failure and presence of a positive culture
* Insufficient blood flow to the limb requiring a revascularization procedure
D: Inclusion Criteria:

* Diagnosis of acute bacterial skin-structure infection (ABSSI) of no more than 7 days duration which was suspected or proven to be caused, at least in part, by a gram-positive pathogen.
* Eligible infections included cellulitis measuring at least 10 cm length and width or 100 cm squared, with or without a focal abscess, and surgical or traumatic wound infections
* Infection which in the opinion of the investigator will require 10-14 days of antibacterial therapy.
* Have at least 3 of the following local and/or systemic symptoms and/or signs of infection: purulent or seropurulent drainage/discharge, erythema, fluctuance, heat/localized warmth, pain/tenderness to palpation, swelling/induration, regional lymph node swelling or tenderness, temperature \>=100.4 degree F, increased white blood cell count, or bandemia.
* Must not have received treatment with another systemic antibiotic for the current ABSSI.

Exclusion Criteria:

* Superficial skin structure infections such as folliculitis, carbuncles, furunculosis, cutaneous abscesses, and simple cellulitis.
* Infections involving burns, human or animal bites, or chronic diabetic foot ulcers.
* Suspected polymicrobial infection involving Pseudomonas aeruginosa
* Anticipated need for \>14 days of antibiotic therapy.
* Infections complicated by the presence of prosthetic materials that will not be removed, such as permanent cardiac pacemaker battery packs, mesh, or joint replacement prosthesis.
* Known significant renal, hepatic, or hematologic impairment.
* Received prior potentially effective antimicrobial therapy for the acute bacterial skin and skin structure infection, unless they were failing therapy after 48 hours or had a gram-positive pathogen non-susceptible to prior therapy identified as a causative pathogen.

Answer: D