The purpose of this study is to learn if an experimental antibiotic calledTR-701 FA can safely and effectively treat an acute bacterial skin or skinstructure infection. The experimental antibiotic will be tested against thealready approved antibiotic Linezolid adminstered intravenous to oral. The sponsor of the study wants to prove, that the new medication isn't inferior regarding efficacy and safety as compared to the already approved medication Linezolid.

Conditions: Acute Bacterial Skin and Skin Structure Infections
MedDRA version: 14.1Level: PTClassification code 10040872Term: Skin infectionSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2011-002860-26-DE

Lead Sponsor: Trius Therapeutics, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 658

Inclusion Criteria

Patients who meet all of the following diagnostic and inclusion criteria for ABSSSI are eligible for the study:
1. Males or females = 12 years old
2. Adequate venous access for a minimum of 2 IV doses of study drug
3. ABSSSI meeting at least 1 of the clinical syndrome definitions listed below and requiring IV antibiotic therapy. Local symptoms must have started within 7 days before the Screening Visit.
a. Cellulitis/erysipelas defined as a diffuse skin infection, characterized by all of the following within 24 hours:
• Rapidly spreading areas of erythema, edema, and/or induration of a minimum total lesion surface area of 75 cm2
• No collection of pus apparent upon visual examination (diagnosis still consistent with cellulitis/erysipelas if pus is collected from the lesion)
• At least 2 of the following signs of infection:
? Erythema
? Induration
? Localized warmth
? Pain or tenderness on palpation
? Swelling/edema
• At least 1 of the following regional or systemic signs of infection:
? Lymph node tenderness and increase in volume or palpable proximal to the primary ABSSSI
? Fever, defined as body temperature = 38°C (100.4°F) oral, = 38.5°C (101.3°F) tympanic, or = 39°C (102.2°F) rectal (observed by a health care provider)
? White blood cell (WBC) count = 10,000 cells/mm3 or < 4000 cells/mm3
? > 10% immature neutrophils
b. Major cutaneous abscess defined as an infection characterized by a collection of pus apparent upon visual examination spreading within the dermis or deeper that is accompanied by all of the following within 24 hours:
• Erythema, edema, and/or induration extending at least 5 cm in the shortest distance from the peripheral margin of the abscess and with a minimum total lesion surface area of 75 cm2
• At least 1 of the following signs of infection:
? Fluctuance
? Incision and drainage required
? Purulent or seropurulent drainage
? Localized warmth
? Pain or tenderness on palpation
• At least 1 of the following regional or systemic signs of infection:
? Lymph node tenderness and increase in volume or palpable proximal to the primary ABSSSI
? Fever, defined as body temperature = 38°C (100.4°F) oral, = 38.5°C (101.3°F) tympanic, or = 39°C (102.2°F) rectal (observed by a health care provider)
? WBC count = 10,000 cells/mm3 or < 4000 cells/mm3
? > 10% immature neutrophils
c. Wound Infection defined as an infection of any apparent break in the skin characterized by the following:
• Superficial incision surgical site infection meeting all of the following criteria:
? Follows clean surgery (elective, not emergency, nontraumatic, primarily closed, no acute inflammation; no break in technique; respiratory, gastrointestinal, biliary, and genitourinary tracts not entered)
? Involves only the skin or subcutaneous tissue around the incision, does not involve fascia
? Occurs within 30 days after procedure
? Original surgical incision =3 cm
? Purulent drainage (spontaneous or therapeutic) with surrounding erythema, edema, and/or induration extending at least 5 cm in the shortest distance from the peripheral margin of the wound and with a minimum total lesion surface area of 75 cm2
? At least 1 of the following regional or systemic signs of infection:
• Lymph node tenderness and increase in volume or palpable proximal to the primary ABSSSI
• Fever, defined as body temperature = 38°C (100.4°F) oral, = 38.5°C (101.3°F) tympanic, or = 39°C (102.2°F) rectal (observed by a health care provider)
•

Exclusion Criteria

Patients who meet any of the following criteria are not eligible to participate in this study:
1. Uncomplicated skin and skin structure infections such as furuncles, minor abscesses (area of suppuration not surrounded by cellulitis/erysipelas), impetiginous lesions, superficial or limited cellulitis/erysipelas, and minor wound infections (eg, stitch abscesses)
2. Infections associated with, or in close proximity to, a prosthetic device
3. Severe sepsis or septic shock
4. Known bacteremia at time of screening
5. 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 infection, 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)
• Infected human or animal bites. However, arthropod (eg, insects, spiders, ‘bugs’) bites are allowed; these are not considered animal bites in this study
• Infections at vascular catheter sites or involving thrombophlebitis
• Incision surgical site infection with any of the following characteristics:
? Follows clean-contaminated surgery (urgent or emergency case that is otherwise clean, elective opening of respiratory, gastrointestinal, biliary, or genitourinary tract with minimal spillage [eg, appendectomy] not encountering infected urine or bile; minor technique break)
? Follows contaminated surgery (nonpurulent inflammation; gross spillage from gastrointestinal tract; entry into biliary or genitourinary tract in the presence of infected bile or urine; major break in technique; chronic open wounds to be grafted or covered)
? Follows dirty surgery (purulent inflammation [eg, abscess]; preoperative perforation of respiratory, gastrointestinal, biliary, or genitourinary tract)
? Extends into the fascia or muscle layers, organs, or spaces
6. Use of antibiotics as follows:
? Systemic antibiotic with gram-positive cocci activity for the treatment of any infection within 96 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 except for antibiotic/antiseptic-coated dressing applied to the clean postsurgical wound
7. Administration of linezolid within 30 days before the first infusion of study drug
8. Recent history of opportunistic infections where the underlying cause of these infections is still
active (eg, leukemia, transplant, acquired immunodeficiency syndrome [AIDS])
9. Receiving chronic systemic immunosuppressive therapy such as prednisone doses = 20 mg per day for = 3 of the last 12 months OR therapies that in the Investigator’s judgment could predispose to opportunistic infections
10. Chronic (daily for the previous 30 days) use of antipyretic medication (eg, acetaminophen, paracetamol, nonsteroidal anti-inflammatory drugs). Low-dose aspirin (= 200 mg per day) for cardiovascular prophylaxis is allowed
11. Receivi