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Efficacy and Safety of Intravenous to Oral 6-Day Tedizolid Phosphate vs. Intravenous to Oral 10-Day Linezolid in Patients With Acute Bacterial Skin and Skin Structure Infection (ABSSSI)

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ClinicalTrials.gov Identifier: NCT02066402
Recruitment Status : Completed
First Posted : February 19, 2014
Results First Posted : June 7, 2017
Last Update Posted : June 7, 2017
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Bayer

Brief Summary:
This study is aimed to evaluate the efficacy and safety between Tedizolid 200mg daily (intra venous) I.V. to oral for 6-day treatment compared with that of Linezolid 600mg twice daily I.V. to oral for 10-day treatment Acute Bacterial Skin and skin structure infection (ABSSSI).This is a double-blind, randomized, active control, 7-10days treatment for all subjects.

Condition or disease Intervention/treatment Phase
Bacterial Infections Drug: Tedizolid (BAY119-2631) Drug: Placebo Tedizolid (BAY119-2631) Drug: Linezolid Drug: Placebo Linezolid Phase 3

Detailed Description:

Number of participants with adverse evnets as a measure of safety and tolerability will be covered in Adverse Events section.

ABSSSI Efficacy Safety Tedizolid Phosphate Linezolid


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 598 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of Intravenous to Oral 6-Day Tedizolid Phosphate and Intravenous to Oral 10-Day Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections
Actual Study Start Date : March 4, 2014
Actual Primary Completion Date : March 6, 2016
Actual Study Completion Date : April 18, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tedizolid Phosphate (Sivextro, BAY119-2631)
Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo.
Drug: Tedizolid (BAY119-2631)
50 % of the participants will be randomized to this arm and will receive 200 mg Tedizolid once daily i.v to oral from 1-6 days

Drug: Placebo Tedizolid (BAY119-2631)
50 % of the participants will be randomized to this arm and will receive 200 mg Placebo Tedizolid once daily i.v to oral from 7-10 days

Drug: Placebo Linezolid
50 % of the participants will be randomized to this arm and will receive 600 mg Placebo Linezolid twice daily i.v. to oral from 1-10 days

Active Comparator: Linezolid
Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days.
Drug: Placebo Tedizolid (BAY119-2631)
50 % of the participants will be randomized to this arm and will receive 200 mg Placebo Tedizolid once daily i.v to oral from 7-10 days

Drug: Linezolid
50 % of the participants will be randomized to this arm and will receive 600 mg Linezolid twice daily i.v. to oral from 1-10 days




Primary Outcome Measures :
  1. Percentage of Participants With Early Clinical Response at 48-72 Hours After the First Infusion of Study Drug in the ITT Analysis Set. [ Time Frame: Baseline and 48-72 hours visit ]
    Early clinical response is defined as responder if there is >=20% reduction in the area of erythema, edema, and/or induration (length × width) of the primary acute bacterial skin and skin structure infections (ABSSSI) lesion, compared with baseline at the 48-72 Hour visit.


Secondary Outcome Measures :
  1. Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the ITT Analysis Set [ Time Frame: Baseline and EOT visit (Day 11) ]
    Clinical Failure: Presence of fever; No lesion size decrease from baseline; Clinician assessment of tenderness worse than mild; Persistent same or great intensity purulent drainage of wound infection; Confounding use of systemic concomitant antibiotic; TEAE lead to study drug discontinuation; Require additional antibiotic treatment for primary lesion; Unplanned major surgical intervention. Clinical Success: Afebrile or fever due to other cause; Lesion size decrease from baseline; Clinician assessment of mild/absent tenderness; None/lesser intensity purulent drainage of wound infection; None confounding use of systemic concomitant antibiotic; None TEAE leading to study drug discontinuation; No additional antibiotic therapy for primary lesion; No unplanned major surgical intervention; No osteomyelitis after baseline; For wound/abscess: no incision/drainage of the ABSSSI site after Day1 unless planned. For cellulitis/ersipelas: no incision/drainage of the ABSSSI site after 48‑72 H Visit.

  2. Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the Clinically Evaluable at EOT (CE-EOT) Analysis Set [ Time Frame: Baseline and EOT visit (Day 11) ]
    Clinical response will be defined as percentage of participants with clinical success, clinical failure or indeterminate.

  3. Overall Investigator's Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the ITT Analysis Set [ Time Frame: Baseline and post-therapy evaluation visit (7-14 days after Day 11) ]
    The Investigator made an assessment of clinical response at the PTE Visit (7-14 days after the EOT Visit +2 days). Participants assessed as a clinical failure at the EOT Visit are considered a clinical failure at the PTE Visit. Percentage of participants with clinical success, clinical failure or indeterminate were reported.

  4. Overall Investigator's Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the Clinically Evaluable at Post Therapy Evaluation (CE-PTE) Analysis Set [ Time Frame: Baseline and post-therapy evaluation visit (7-14 days after Day 11) ]
    The Investigator made an assessment of clinical response at the PTE Visit (7-14 days after the EOT Visit +2 days). Participants assessed as a clinical failure at the EOT Visit are considered a clinical failure at the PTE Visit. Percentage of participants with clinical success, clinical failure or indeterminate were reported.

  5. Investigator's Assessment of Clinical Response at 48-72 Hours [ Time Frame: Baseline and at 48-72 hours ]
    The Investigator made an assessment of clinical response at the 48-72 Hour Visit based on following definition: Improving (Improvement in overall clinical status of ABSSSI compatible with continuation of study drug therapy); Stable (Signs and symptoms stable, no apparent change in overall clinical status but compatible with continuation of study drug therapy); Other.

  6. Investigator's Assessment of Clinical Response at Day 7 Visit [ Time Frame: Baseline and Day 7 visit ]
    The Investigator made an assessment of clinical response at Day 7 Visit based on following definition: Improving (Improvement in overall clinical status of ABSSSI compatible with continuation of study drug therapy); Other.

  7. Value of the Visual Analog Scale (VAS) Pain Scores at Each Time Point [ Time Frame: Up to EOT visit (Day 11) ]
    The patient-reported level of pain were assessed by the visual analog scale (VAS) pain score. VAS pain score ranged from 0 mm (no pain) to 100 mm (worst pain ever). It used a 100 mm VAS to instruct the patient to indicate the point along the line that represents the pain they are feeling. Once the patient indicates how much pain they are feeling, measure the distance from no pain and enter the value.

  8. Change From Baseline in the Visual Analog Scale (VAS) Pain Scores at Each Time Point [ Time Frame: Up to EOT visit (Day 11) ]
    The patient-reported level of pain were assessed by the visual analog scale (VAS) pain score. VAS pain score ranged from 0 mm (no pain) to 100 mm (worst pain ever). It used a 100 mm VAS to instruct the patient to indicate the point along the line that represents the pain they are feeling. Once the patient indicates how much pain they are feeling, measure the distance from no pain and enter the value.

  9. Value of the Faces Rating Scale (FRS) Pain Scores at Each Time Point [ Time Frame: Up to EOT visit (Day 11) ]
    The patient-reported level of pain were assessed by the faces rating scale (FRS) pain score. Ask the patient to rate their pain from 0 to 10 with 0 being no pain at all and 10 being the worst pain then enter the numerical value.

  10. Change From Baseline in the Faces Rating Scale (FRS) Pain Scores at Each Time Point [ Time Frame: Up to EOT visit (Day 11) ]
    The patient-reported level of pain were assessed by the faces rating scale (FRS) pain score. The patient-reported level of pain were assessed by the faces rating scale (FRS) pain score. Ask the patient to rate their pain from 0 to 10 with 0 being no pain at all and 10 being the worst pain then enter the numerical value.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females >/=18 years old
  • Adequate venous access for a minimum of 2 I.V. doses of study drug
  • Acute Bacterial Skin and skin structure infection (ABSSSI) meeting at least 1 of the clinical syndrome definitions listed below and requiring I.V. antibiotic therapy. Local symptoms must have started within 7 days before the Screening Visit

    • Cellulitis/erysipelas
    • Major cutaneous abscess
    • Wound Infection
  • Suspected or documented gram-positive infection from baseline Gram stain or culture.

Exclusion Criteria:

  • Uncomplicated skin and skin structure infections such as furuncles, minor abscesses
  • Infections associated with, or in close proximity to, a prosthetic device
  • Severe sepsis or septic shock
  • Known bacteremia at time of screening
  • ABSSSI due to or associated with any of the following:

    • Suspected or documented gram-negative pathogens in patients with cellulitis/erysipelas or major cutaneous abscess that require an antibiotic with specific gram-negative coverage. Patients with wound infections where gram-negative adjunctive therapy is warranted may be enrolled if they meet the other eligibility criteria
    • Diabetic foot infections, gangrene, or perianal abscess
    • Concomitant infection at another site not including a secondary ABSSSI lesion (eg, septic arthritis, endocarditis, osteomyelitis)
    • Infected burns
    • Decubitus or chronic skin ulcer, or ischemic ulcer due to peripheral vascular disease (arterial or venous)
    • Any evolving necrotizing process (ie, necrotizing fasciitis)
  • Use of antibiotics as follows:

    • Systemic antibiotic with gram-positive cocci activity for the treatment of any infection within 24 hours before the first infusion of study drug
    • Patients who failed prior therapy for the primary infection site are also excluded from enrollment
    • Topical antibiotic on the primary lesion within 24 hours before the first infusion of study drug except for antibiotic/antiseptic-coated dressing applied to the clean postsurgical wound
  • Administration of Linezolid within 30 days before the first infusion of the study drug
  • Recent history of opportunistic infections where the underlying cause of these infections is still active (eg, leukemia, transplant, acquired immunodeficiency syndrome [AIDS])
  • Previous exposure to Tedizolid Phosphate treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02066402


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Sponsors and Collaborators
Bayer
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Bayer Study Director Bayer

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02066402     History of Changes
Other Study ID Numbers: 16121
First Posted: February 19, 2014    Key Record Dates
Results First Posted: June 7, 2017
Last Update Posted: June 7, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Bacterial Infections
Linezolid
Tedizolid
Tedizolid phosphate
Oxazolidinones
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action