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Keep this study
Lead
Melinta Therapeutics, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adult (≥ 18 years of age) men or women
Sexually active women and men with partners of childbearing potential must agree to use an acceptable form of contraception as determined by the investigator during participation in the study and for 30 days after the final dose of study drug
Female partners of male subjects should also use an additional reliable method of contraception during study and for 30 days after the final dose of study drug
Subjects must have a diagnosis of ABSSSI - one or more of the following 4 infection types: cellulitis/erysipelas, wound infection, major cutaneous abscess, or burn infection
Subjects must have lymph node enlargement due to the present infection or at least one of the following symptoms of systemic infection: fever ≥ 38°C, lymphangitis, WBC (white blood cell) count ≥ 15,000 cells/μL, elevated C-reactive protein (\> 5.0mg/L)
In the opinion of the investigator, the subject must require and be a suitable candidate for IV antibiotic therapy
You may not be if
A medical history of significant hypersensitivity or allergic reaction to quinolones, linezolid, vancomycin, or vancomycin derivatives
Women who are pregnant or lactating
Any chronic or underlying skin condition at the site of infection that may complicate the assessment of response
Subjects with any of the following: infection involving prosthetic materials or foreign bodies, infection associated with a human or animal bite, osteomyelitis, decubitus ulcer, diabetic foot ulcer, septic arthritis, mediastinitis, necrotizing fasciitis, anaerobic cellulitis, or synergistic necrotizing cellulitis, myositis, tendinitis, endocarditis, toxic shock syndrome, gangrene, burns covering ≥ 10% of body surface area, severely impaired arterial blood supply, current evidence of deep vein thrombosis or superficial thrombophlebitis
Minor abscesses, unless present with one of the ABSSSI types
Any infection expected to require other antimicrobial agents in addition to study drug
Receipt of \> 24 hours of systemic antibiotic therapy in the 14 days before enrollment unless one of the following is documented: the subject received a single dose of a short-acting antibacterial drug 3 or more days before clinical trial enrollment for surgical prophylaxis or recently completed treatment with an antibacterial drug for an infection other than ABSSSI and the drug does not have antibacterial activity against bacterial pathogens that cause ABSSSI
Receipt of more than 1 dose of a potentially effective antibacterial agent for treatment of the ABSSSI under study prior to enrollment
Receipt of chronic anti-inflammatory therapy for longer than 14 days before enrollment
Severely compromised immune systems
Subjects taking any medicinal product which inhibits monoamine oxidases A or B or within 2 weeks of Screening
Hypertension as defined by a systolic blood pressure of ≥ 180 mmHg or a diastolic blood pressure of ≥110 mmHg with confirmed re-check within 20 minutes of initial reading
Subjects with pheochromocytoma, thyrotoxicosis and/or subjects taking any of the following types of medications: sympathomimetic agents, vasopressive agents, dopaminergic agents, or other agents with the potential for serotonergic interactions
Subjects with carcinoid syndrome and/or subjects taking any of the following medications: serotonin re-uptake inhibitors, tricyclic antidepressants, serotonin 5-HT1 (serotonin receptor) receptor agonists, meperidine, or buspirone
Known history of liver disease
History of severe renal impairment
Life expectancy of \< 3 months
Any underlying disease that, in the opinion of the investigator, could interfere with the subject's ability to participate in the study
Subjects previously randomized in this study or in who have received a dose of an investigational drug within 30 days of randomization
Subjects \> 140 kg in body weight
Clareo Health | A Study to Assess Objective Endpoint Measurements of Response in Bacterial Skin Infections
