Last updated: 11/07/2018 06:05:43

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

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GSK study ID
113414
See study documents
Clinicaltrials.gov ID
NCT01209078
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Randomized, Double Blind, Double Dummy Multicenter Phase IIa Study to Assess Safety, Tolerability and Efficacy of GSK1322322 Versus Linezolid in the Treatment of Acute Bacterial Skin and Skin Structure Infection
Trial description: This study will determine the safety, tolerability and efficacy of GSK1322322 verses Linezolid in subjects with Acute Bacterial Skin and Skin Structure Infection (ABSSSI).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

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

Mean clinical chemistry parameter of high sensitivity C-Reactive protein at indicated time points

Timeframe: Up to Follow-up (7 Day Follow-up, Day 19)

Mean hematology parameters of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, white blood cells (WBC) and platelet count at indicated time points

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

Mean hematology parameter of mean corpuscle volume (MCV) at indicated time points

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

Mean hematology parameter of hemoglobin, mean corpuscle hemoglobin concentration (MCHC) at indicated time points

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

Mean hematology parameter of mean corpuscle hemoglobin (MCH) at indicated time points

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

Mean hematology parameter of red blood cell (RBC) count and reticulocyte count at indicated time points

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

Mean vital sign value of systolic blood pressure (SBP) and diastolic blood pressure (DBP) at indicated time points

Timeframe: Up to Day 11

Mean vital sign value of heart rate (HR) at indicated time points

Timeframe: Up to Day 11

Mean vital sign value of respiratory rate (RR) at indicated time points

Timeframe: Up to Day 11

Mean change from Baseline in SBP and DBP at indicated time points

Timeframe: Day 1 (Baseline) up to Day 11

Mean change from Baseline in HR at indicated time points

Timeframe: Day 1 (Baseline) up to Day 11

Mean change from Baseline in RR at indicated time points

Timeframe: Day 1 (Baseline) up to Day 11

Mean electrocardiogram (ECG) values at indicated time points

Timeframe: Up to Day 11

Mean change from Baseline in ECG values at indicated time points

Timeframe: Day 1 (pre-dose, Baseline) up to Day 11

Mean ECG rhythms at indicated time points

Timeframe: Up to Day 11

Mean change from Baseline in ECG rhythms at indicated time points

Timeframe: Day 1 (pre-dose, Baseline) up to Day 11

Number of participants with abnormal transition from Baseline in clinical chemistry values relative to normal range

Timeframe: Day 1 (pre-dose, Baseline) up Follow-up (28 Day Follow-up, Day 40)

Number of participants with abnormal transition from Baseline in hematology values relative to normal range

Timeframe: Day 1 (pre-dose, Baseline) up Follow-up (28 Day Follow-up, Day 40)

Secondary outcomes:

Number of participants with clinical success of clinical response

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

Percentage of participants with clinical success of clinical outcome

Timeframe: Day 11 (end of therapy) and Follow-up (7 Day Follow-up, Day 19)

Percentage of participants with microbiological success of microbiological outcome at end of therapy

Timeframe: Day 11 (end of therapy)

Percentage of participants with microbiological success of microbiological outcome at Follow-up

Timeframe: Follow-up (7 Day Follow-up, Day 19)

Percentage of participants with therapeutic success of therapeutic outcome

Timeframe: Follow-up (7 day Follow-up, Day 19)

Mean short form McGill pain questionnaire-2 (SF-MPQ-2) sub-score of continuous pain, intermittent pain, neuropathic pain and affective descriptors at indicated time points

Timeframe: Up to Follow-up (7 Day Follow up, Day 19)

Mean exudate or pus sub-score of SIS at indicated time points

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

Mean total SIS at indicated time points

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

Mean change from Baseline in total SIS at indicated time points

Timeframe: Day 1 (Baseline ) up to Follow-up (28 Day Follow-up, Day 40)

Mean change from Baseline in wound area at indicated time points

Timeframe: Day 1 (Baseline) up to Follow-up (28 Day Follow-up, Day 40)

Percentage of participants with clinical success at end of therapy by pathogen isolated at Baseline

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

Population pharmacokinetic parameters of apparent total clearance of GSK1322322 from plasma after oral administration (CL/F)

Timeframe: Day 1 (0.25-1.5 hours post-initial dose, 1.5-3 hours post-initial dose), Day 4 (4-12 hours post-morning dose) and Day 8 (pre-morning dose)

Interventions:
  • Drug: GSK1322322
  • Drug: Linezolid
  • Drug: GSK1322322 placebo
  • Drug: Linezolid placebo
    • Enrollment:
    84
    Primary completion date:
    2011-18-01
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Skin Infections, Bacterial
    Product
    lanopepden
    Collaborators
    Not applicable
    Study date(s)
    August 2010 to January 2011
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • 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
    • Current or chronic history of liver disease, or known hepatic or biliary abnormalities
    • The subject has been diagnosed with Acquired immune deficiency syndrome (AIDS)
    Inclusion and exclusion 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

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    Oceanside, California, United States, 92056
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Long Beach, California, United States, 90813
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Anniston, Alabama, United States, 36207
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Honolulu, Hawaii, United States, 96813
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    West Reading, Pennsylvania, United States, 19611
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    La Mesa, California, United States, 91942
    Status
    Study Complete
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    Showing 1 - 6 of 7 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2011-18-01
    Actual study completion date
    2011-18-01

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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