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 range

18 Years

Sex

ALL

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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 range

18 Years

Sex

ALL

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