CompletedPhase 2

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

United States84 participantsStarted 2010-08-17

Plain-language 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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

What they're measuring

Number of Participants With Any Adverse Events (AE) and Serious Adverse Events (SAE)

Timeframe: Up to Follow-up (28 Day Follow-up, Day 40)

Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points

Timeframe: Up to Follow-up (28 Day Follow-up, Day 40)

Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points

Timeframe: Up to Follow-up (28 Day Follow-up, Day 40)

Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points

Timeframe: Up to Follow-up (28 Day Follow-up, Day 40)

Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points

Timeframe: Up to Follow-up (28 Day Follow-up, Day 40)

Mean Clinical Chemistry Parameter of Estradiol at Indicated Time Point

Timeframe: Day 1

Trial details

NCT IDNCT01209078

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-01-18

Results submitted2017-09-22

View on ClinicalTrials.gov More Skin Infections, Bacterial trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants With Any Adverse Events (AE) and Serious Adverse Events (SAE)

Timeframe: Up to Follow-up (28 Day Follow-up, Day 40)

Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points

Timeframe: Up to Follow-up (28 Day Follow-up, Day 40)

Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points

Timeframe: Up to Follow-up (28 Day Follow-up, Day 40)

Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points

Timeframe: Up to Follow-up (28 Day Follow-up, Day 40)

Mean Clinical Chemistry Parameter of Estradiol at Indicated Time Point

Timeframe: Day 1