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

Completed · Phase 2

Conditions studied: Skin and Subcutaneous Tissue Bacterial Infections

In brief

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

Key facts

Study ID

NCT01283581

Run by

Melinta Therapeutics, Inc.

People needed

256

Starts

2011-01-01

Expected to finish

2011-11-01

Last updated by the study team

2019-10-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• University of South Alabama Medical Center — Mobile, Alabama, United States
• Drug Research and Analysis Corp — Montgomery, Alabama, United States
• Southbay Pharma Research — Buena Park, California, United States
• eStudySite — Chula Vista, California, United States
• eStudySite — La Mesa, California, United States
• HealthCare Partners Medical Group — Los Angeles, California, United States
• eStudySite — Oceanside, California, United States
• HealthCare Partners Medical Group — Pasadena, California, United States
• Christiana Care Health Services — Newark, Delaware, United States
• Riverside Clinical Research — Edgewater, Florida, United States
• River City Clinical Research — Jacksonville, Florida, United States
• Central Florida Internists — Kissimmee, Florida, United States
• Central Florida Internists Medical — Orlando, Florida, United States
• Central Florida Internists — Saint Cloud, Florida, United States
• Ronald Barbour, MD — Temple Terrace, Florida, United States
• Southeast Regional Research Group — Columbus, Georgia, United States
• Atlanta Institute for Medical Research, Inc — Decatur, Georgia, United States
• Southeast Regional Research Group — Savannah, Georgia, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Four Rivers Clinical Research, Inc — Paducah, Kentucky, United States
• Medical Development Centers, LLC — Baton Rouge, Louisiana, United States
• University of Missouri Health Care — Columbia, Missouri, United States
• Mercury Street Medical Group, PLLC — Butte, Montana, United States
• eStudySite — Las Vegas, Nevada, United States
• South Jersey Infectious Disease — Somers Point, New Jersey, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.