Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Written informed consent provided by the patient
Males and females ≥ 18 years of age

Diagnosis of complicated skin and skin structure infection defined as infection which meets the following criteria:

Suspected to be caused by bacterial pathogens, including multi-drug resistant organisms such as MRSA, and

Involves deeper soft tissue and/or require significant surgical intervention such as:

major abscesses
infected burn (less than or equal to 20% body surface area)
traumatic wound infection
deep/extensive cellulitis
surgical wound infection
infected ulcer (with the exception of multiple infected ulcers at distant sites.) Please Note: Patients with multiple sites of skin infection may be enrolled in the study. The most severely affected site or the one most likely to yield a positive culture should be chosen to follow throughout the course of evaluations.

Presents with at least TWO of the following local symptoms:

Purulent or seropurulent drainage/discharge
Erythema
Fluctuance
Heat/Localized Warmth
Pain/tenderness to palpation
Swelling/induration

At least ONE of the following systemic signs of infection

Increased Temperature (≥100.4ºF/≥38.0ºC) measured orally or its equivalent (note: other methods of obtaining temperature are acceptable)
WBC (>10,000 cells/mm3)
Immature neutrophils (>10% band forms regardless of the total peripheral white count)
Require initial hospitalization with at least 7 days of parenteral therapy for treatment of suspected cSSSI infection
Ability to obtain a culture and Gram stain of the cSSSI site within 48 hours prior to the initiation of study medication;

Exclusion Criteria:

Female patients who are pregnant, lactating (breast milk feeding), or planning a pregnancy during the course of the study, or who are of child bearing potential and not using an acceptable method of birth control (ie, surgically sterile, intrauterine device, oral contraceptive plus barrier contraceptive, hormone delivery system plus barrier contraceptive or condom in combination with contraceptive cream, jelly or foam)

Received more than 24 hours of systemic antibiotic therapy within 96 hours of initiation of study medication for the current episode of cSSSI, unless:

there is evidence of clinical failure following at least 48 hours of prior, non-study systemic therapy OR
there is microbiological evidence of failure (ie, Gram stain reveals WBC and at least one potential pathogen or isolation of an organism resistant to the prior therapy)
Concomitant conditions requiring antimicrobial therapy that would interfere with the evaluability of the condition under study
Anticipated need for prolonged antibiotic therapy (ie, >14 days)
Topical use of antimicrobials (excluding vaginally or topically administered antifungal agents)
cSSSI known or suspected to be caused by fungal, parasitic or viral infections

cSSSI of the following categories:

infected diabetic foot ulcers or decubitus ulcer
multiple infected ulcers at distant sites
involve an ischemic ulcer due to peripheral vascular disease
presence of gangrene of any etiology
Necrotizing fasciitis or gas gangrene
Infections resulting from human or animal bites (excluding infections secondary to arthropod bites)
Known or suspected osteomyelitis or septic arthritis
Superinfected eczema or other chronic medical conditions (eg, atopic dermatitis, hidradentitis suppurativa) characterized by prominent signs of inflammation for an extended period even after successful bacterial eradication
Patients who have undergone more than two surgical interventions (defined as surgery that cannot be performed at the bedside) for treatment of cSSSI at the time of enrollment
Patients who are expected to require more than two surgical interventions (defined as surgery that cannot be performed at the bedside) for treatment of cSSSI during the first 48 hours following study enrollment
Infections complicated by the presence of prosthetic materials that will not be removed such as permanent intracardiac devices or joint replacement prosthesis
Moderately or severely impaired renal function with known creatinine clearance <50 mL/min (based on the Cockcroft-Gault formula using ideal body weight)
ALT or AST >3x upper limit of normal or bilirubin >1.5x upper limit of normal (ULN)
Neutropenia defined as an absolute neutrophil count <500/mm3
Thrombocytopenia defined as a platelet count <50,000 cells/mm3
Infection with human immunodeficiency virus and a CD4 count known at the time of enrollment to be <200 cells/mm3 or another Acquired Immune Deficiency Syndrome (AIDS)-defining illness
Requiring concomitant administration of systemic corticosteroids greater than 40 mg/day of prednisolone (or equivalent)
Treatment with cancer chemotherapy, radiotherapy, or potent, non-corticosteroid immunosuppressant drugs (eg, cyclosporine, azathioprine, tacrolimus, immune-modulating monoclonal antibody therapy, etc.) within the 3 months prior to study enrollment
Concomitant therapy with medications known to lower seizure threshold or those patients with a history of seizure disorder
Concomitant therapy with medications known to be associated with QTc prolongation potential (eg, Class IA and Class III anti-arrhythmic agents)

History or significant cardiac disease defined by the following:

New York Heart Association (NYHA) Class III or IV heart failure
History or risk of ventricular arrhythmia (excluding isolated premature ventricular contractions [PVC's] or consecutive PVC's <10 beats), Torsades de Pointes, 2nd or 3rd degree AV block, or QTc interval >470 mm/sec
History of any hypersensitivity or allergic reaction to beta-lactam drugs such as carbapenems, penicillins, or cephalosporins
History of any hypersensitivity or allergic reaction to vancomycin or history of Red Man Syndrome
Any planned medical intervention or personal event that might interfere with the ability to comply with the study requirements
Any condition that, in the opinion of the principal investigator, would compromise the safety of the patient or the quality of the data
Life expectancy of less than 3 months from the time of enrollment
Use of an investigational drug or device (ie, a drug or device without an FDA approved indication) within the previous 30 days
Prior participation in this protocol
Unable or unwilling to adhere to the study-specified procedures and restrictions