A PHASE 3 RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER STUDY TO COMPARE THE SAFETY AND EFFICACY OF OMADACYCLINE IV/PO TO LINEZOLID IV/PO FOR TREATING ADULT SUBJECTS WITH ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTION (ABSSSI)
- Conditions
- -L08L08
- Registration Number
- PER-038-15
- Lead Sponsor
- Paratek Pharma, LLC,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 9
1. Written and signed informed consent must be obtained before any assessment is performed.
2. Male or female, age 18 years or older.
3. Has a qualifying skin and skin structure infection. All qualifying lesions must be ≥ 75 cm2 in total surface area of contiguous involved tissue, calculated as the product of the maximum length (head-to-toe) multiplied by the maximum width (measured perpendicular to length) as measured by the investigator using a wound ruler. Involved tissue is defined as tissue exhibiting clear evidence of one or more of the following: erythema, edema or induration.
The classification of qualifying infections is shown below.
a. Wound infection – an infection characterized by purulent drainage from a wound with surrounding erythema, edema, and/or induration extending at least 5 cm in the shortest distance from the peripheral margin of the wound.
b. Cellulitis – a diffuse skin infection characterized by spreading areas of erythema, edema, and/or induration.
c. Major abscess – an infection characterized by a collection of pus within the dermis or deeper with surrounding erythema, edema, and/or induration extending at least 5 cm in the shortest distance from the peripheral margin of the abscess.
4. Has evidence of a systemic inflammatory response within the 24 hours prior to randomization, as indicated by ONE of the following:
● Elevated white blood cell (WBC) count (≥ 10,000 cells/mm3)or leukopenia (≤ 4,000 cells/mm3)
● Elevated immature neutrophils (≥ 15% band forms) regardless of total peripheral WBC count
● Lymphatic involvement: lymphangitis or lymphadenopathy that is proximal to and in a location that suggests drainage from the qualifying infection
● Fever or hypothermia documented by the investigator (oral or rectal temperature > 38.0°C [100.4°F] or < 36.0°C [95.5°F])
5. Females must have a negative urine pregnancy test at Screening and agree to comply with using a highly effective form of birth control (eg, abstinence, oral contraceptive, intrauterine device [IUD], barrier contraception [condom], tubal ligation, hysterectomy, bilateral oophorectomy, or vasectomized partner) from Screening through PTE. Males must agree to use a highly effective method of birth control with female partner(s) and must not donate sperm from Screening through Post Therapy Evaluation (PTE).
1. Has received 1 or more doses of a potentially effective systemic antibacterial treatment within the 72 hour period prior to first dose of test article (a subject will be considered to have received a potentially effective systemic antibacterial treatment if the pathogen identified as causing the infection is shown to be susceptible to the antibacterial treatment given or, in the circumstance where a pathogen is not identified, if the antibacterial agent is approved for treatment of skin infections or is known to have activity against any of the leading Gram-positive causes of ABSSSI [eg, Staphylococcus aureus, Streptococcus species [spp.], Enterococcus spp.).
2. Has, for any reason, used a topical antibacterial agent(s) with specific antibacterial activity (eg, mupirocin, retapamulin, fusidic acid) continuously within the 72 hour period prior to first dose of test article, if applied to the skin for ≥ 72 hours.
3. Infections where the outcome is strongly influenced by factors other than protocol-defined treatment and procedures, that require antibacterial treatment for greater than 14 days, are associated with chronic skin lesions that may obscure determination of response even after successful bacterial eradication has been achieved, or are suspected or known to be caused by a pathogen resistant to either test article, eg:
● chronic (persistently present > 3 months) lesions, ulcers or wounds (eg, cellulitis contiguous with a diabetic foot ulcer)
● association with chronic dermatitis or any other chronic inflammatory skin lesion (eg, psoriasis, eczema)
● burns
● peri-rectal abscess (eg, buttock or perineal lesion likely to communicate with the rectum) or perineal infection
● infected decubitus (pressure) ulcers
● necrotizing fasciitis (infections with rapidly progressive destruction of tissue at or below the fascia)
● life-threatening infections, ie, require emergency surgery for the treatment (eg, progressive gangrene)
● infections in an area requiring surgery that in and of itself would cure the infection or remove the infected site (eg, amputation for vascular insufficiency)
● infections associated with severe vascular insufficiency (eg, peripheral vascular disease) or acute occlusion expected to require immediate revascularization
● infections associated with acute compartment syndrome expected to require extensive surgery to provide decompression
● infections accompanied by confirmed or suspected contiguous bone or joint infection (eg, osteomyelitis, septic arthritis, bursitis)
● bacteremic infections associated with an intravascular foreign body
● infections accompanied by another confirmed or suspected infection requiring systemic antibiotic therapy (eg, endocarditis, other endovascular infection, meningitis, visceral abscess, intra-abdominal infection, pneumonia, urinary tract infection)
● human or animal bites (infections associated with insect bites are NOT excluded)
● myonecrosis
● complicated by an immune deficiency in the subject (eg, ecthyma gangrenosum in a neutropenic subject)
● infections associated with the presence of a foreign body (eg, wood, metal, plastic, etc.) if the foreign body cannot be removed within 24 hours of first dose of test article
4. Has known or is clinically suspected for one or more of the following prior
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method