A Study to Assess Objective Endpoint Measurements of Response in Bacterial Skin Infections

Melinta Therapeutics

Status and phase: Completed; Phase 2

Conditions: Skin and Subcutaneous Tissue Bacterial Infections

Treatments: Drug: Vancomycin; Drug: Delafloxacin; Drug: Linezolid

Study type: Interventional

Funder types: Industry

Identifiers

NCT01283581

RX-3341-202

Details and patient eligibility

About

The purpose of this study is to compare clinical response to the measurement techniques of several objective measures of clinical efficacy for use in future ABSSSI (Acute Bacterial Skin and Skin Structure Infection) clinical trials

Enrollment: 256 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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256 participants in 3 patient groups

Delafloxacin

Experimental group

Description:

300 mg IV (intravenous) every 12 hours for 5-14 days

Treatment:

Drug: Delafloxacin

Vancomycin

Active Comparator group

Description:

15 mg/kg, up to 1250 mg, IV every 12 hours for 5-14 dyas

Treatment:

Drug: Vancomycin

Linezolid

Active Comparator group

Description:

600 mg IV every 12 hours for 5-14 days

Treatment:

Drug: Linezolid