GSK1322322 Versus Linezolid in the Treatment of Acute Bacterial Skin and Skin Structure Infection

• Status: Completed
• Trial end date: 2011-01-18
• Target enrollment: 0
• Participant gender: All

Summary

This study will determine the safety, tolerability and efficacy of GSK1322322 verses Linezolid in subjects with Acute Bacterial Skin and Skin Structure Infection (ABSSSI).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Linezolid

Criteria

Inclusion Criteria:

• Male or female subject age 18 years or older at the time of signing the informed consent

• Male subjects must agree to use one of the contraception methods listed

• A female is eligible to enter and participate in this study if she is of non-childbearing potential

• The subject has a diagnosis of ABSSSI defined as one of the following: wound infection with cellulitis that has developed within 30 days of surgery or trauma; abscess with cellulitis, or cellulitis that has developed in no more than 7 days before enrollment with worsening over the past 48 hours OR in the investigator's opinion the patient's condition warrants systemic oral antibiotic therapy

• The subject has at least 2 additional signs and symptoms of skin infection: purulence, erythema with or without induration, fluctuation, heat/localized warmth, and pain/tenderness

• The subject has at least 1 systemic marker of infection: Lymphadenopathy, Fever (>38 degrees Celsius), White Blood Cell elevation, or Creatinine Reactive Protein (CRP) >Upper Limit of Normal (ULN)

• The subject has given written, informed, dated consent to participate in the study

• QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block

• Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) < 2xULN; and bilirubin < 1.0xULN

Exclusion Criteria:

• Current or chronic history of liver disease, or known hepatic or biliary abnormalities

• The subject has been diagnosed with Acquired immune deficiency syndrome (AIDS)

• Body mass index (BMI) >40 kg/m2

• The subject has demonstrated a previous hypersensitivity reaction to GSK1322322, or to oxazolidinones

• The subject has a secondarily infected animal/human bite

• The subject has a chronic ulcerative lesion that is likely to be polymicrobial or caused by anaerobic organisms and unlikely to have Staphylococcus aureus or Streptococcus pyogenes as the causative agent

• The subject has an underlying skin disease, such as pre-existing eczematous dermatitis, with clinical evidence of secondary infection

• The subject has an infection that would normally have a high cure rate after surgical incision alone

• The subject has a bacterial skin infection which, due to the extent, depth or severity of clinical presentation, in the opinion of the investigator, cannot be appropriately treated by an oral antibiotic

• The subject has received more than one dose of treatment with a systemic and/or topical antibacterial within 7 days

• The subject is currently receiving vasopressors

• The subject is currently receiving adrenergic agents

• The subject is currently receiving serotonergic reuptake inhibitors

• The subject is currently receiving monoamine oxidase inhibitors

• The subject has a documented clinical history of pseudomembranous colitis

• The subject has known, pre-existing myelosuppression, or a history of myelosuppression with prior linezolid use, or is currently receiving a medication that produces bone marrow suppression

• The subject has a history of seizures

• The subject has a history of severe renal failure and is undergoing dialysis

• The subject has a serious underlying disease that could be imminently life-threatening

• The subject has been previously enrolled in this study

• The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product

• Subject is unable to discontinue the use of prescription drugs listed in the protocol or non-prescription drugs, including vitamins, herbal and dietary supplements prior to the first dose of study medication through the first follow up visit

• Lactating females or pregnant females as determined by positive urine pregnancy test at screening or prior to dosing