Safety and Efficacy Study of Oxazolidinones to Treat Uncomplicated Skin Infections
Condition: Infectious Skin Diseases; Bacterial Skin Diseases; Staphylococcal Skin Infections; Streptococcal Infections; Abscess
MeSH terms: Infections; Communicable Diseases; Cellulitis; Skin Diseases, Infectious; Streptococcal Infections; Staphylococcal Skin Infections; Skin Diseases, Bacterial; Skin Diseases
Intervention: Radezolid; Radezolid; Linezolid
Intervention description: 450mg PO QD; 450mg PO BID; 600mg PO BID
Intervention MeSH terms: Linezolid; Radezolid; Oxazolidinones
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy, safety and tolerability of RX-1741, an
      oxazolidinone, versus linezolid, another oxazolidinone, in the treatment of uncomplicated
      skin and skin structure infections
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients with uSSSI

          -  Adult (men and women) ≥18 years

          -  Females must be post-menopausal for at least 1 year or surgically sterile

          -  Sexually active males must use a barrier method of birth control during and for 30
             days after the study

          -  Acceptable clinical diagnoses of uSSSI include, but are not limited to: Simple
             abscess, Impetiginous lesions, Folliculitis, Furunculosis, Carbuncles, Cellulitis

          -  The infection is accompanied by 2 or more of the following local signs and symptoms:
             Pain/tenderness, Swelling, Erythema, Localized warmth, Purulent drainage/discharge,
             Induration, Regional lymph node swelling or tenderness, Extension of redness

          -  A sample for microbiologic culture must be obtained from the primary infection site at
             the screening visit

          -  The patient must require and be a suitable candidate for oral antibiotic therapy in
             the opinion of the Investigator and be able to swallow tablets or capsules intact

          -  A written, voluntarily signed informed consent must be obtained from the patient prior
             to the initiation of any study-related procedures

        Exclusion Criteria:

          -  Cellulitis (area greater than 10cm2), chronic or recurrent furunculosis, postoperative
             wound infection, leg ulcer, decubitus ulcer(s), erysipelas, progressive lymphangitis,
             acute paronychia or a deep tissue abscess such as pilonidal or breast abscess. Also
             excluded are skin infections resulting from animal bites

          -  Patients with a complicated skin and skin structure infection as judged by the
             Investigator

          -  Infections that can be treated by surgical incision alone according to the judgment of
             the Investigator

          -  Treatment with the following anti-infective agents prior to study drug administration:
             systemic antibiotic within 7 days; azithromycin within 14 days; a long-acting
             injectable antibiotic within 30 days

          -  Any infection which requires the use of a concomitant antimicrobial agent, in addition
             to study drug

          -  Concomitant topical therapy at the infection site for the period within 48 hours prior
             to study drug administration through TOC

          -  A chronic or underlying skin condition at the site of infection or infections
             involving prosthetic materials

          -  A wound secondary to burn injury or acne vulgaris

          -  Any infection site that requires: intraoperative surgical debridement; excision of
             infected area

          -  Documented or suspected bacteremia

          -  Fungal infection involving the nail bed or scalp at the primary uSSSI site

          -  Significant peripheral vascular disease

          -  An abscess at an anatomical location where the incidence of anaerobic pathogen
             involvement is increased

          -  Patient receiving a daily dose of > 15 mg of systemic prednisone or equivalent, for >
             10 days within the period starting 14 days prior to study drug administration or
             anticipated through TOC

          -  Patient with known human immunodeficiency virus (HIV) infection.

          -  Medical history of hypersensitivity or allergic reaction to linezolid according to the
             judgment of the Investigator

          -  Patients receiving serotonergic agents, selective serotonin reuptake inhibitors
             (SSRIs), or monoamine oxidase inhibitors (MAOIs)

          -  Patients who have severe liver disease

          -  History of pheochromocytoma, untreated hyperthyroidism, untreated or uncontrolled
             hypertension, carcinoid syndrome

          -  Evidence of uncontrolled, clinically significant (according to the judgment of the
             Investigator) cardiovascular, pulmonary, metabolic, gastrointestinal, neurological, or
             endocrine disease; malignancy or psychiatric disorder

          -  Current evidence of deep vein thrombosis or superficial thrombophlebitis

          -  Experienced a recent clinically significant coagulopathy

          -  Evidence of clinically significant immunosuppression

          -  Patient who previously enrolled in this study

          -  Patient who has previously enrolled in any other clinical trial within 4 weeks of
             enrollment through TOC. Treatment with an investigational drug within 4 weeks prior to
             study drug administration

          -  Patient residing in a chronic care facility

          -  Any underlying condition or disease state that would interfere with the completion of
             the study procedures and evaluation of the absorption of study drug