check_circleStudy Completed

Bacterial Infections

Bayer Identifier:
16121
ClinicalTrials.gov Identifier:
NCT02066402
EudraCT Number:
Not Available
EU CT Number:
Not Available
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)

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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.
  • - 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

Trial summary

Enrollment Goal
598
Trial Dates
March 2014 - April 2016
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Sivextro (Tedizolid phosphate, BAY119-2631)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Las Vegas, 89109, United States
Completed
Oceanside, 92056, United States
Completed
Teaneck, 07666, United States
Completed
La Mesa, 91942, United States
Completed
Chula Vista, 91911, United States
Completed
Chengdu, 610041, China
Completed
Chengdu, 610041, China
Completed
Beijing, 100191, China
Terminated
Beijing, 100034, China
Terminated
Beijing, 100044, China
Terminated
Beijing, 100044, China
Completed
Beijing, 100730, China
Completed
Dalian, 116027, China
Completed
Guangzhou, 510180, China
Completed
Guangzhou, 510120, China
Completed
Wuhan, 430030, China
Completed
Changsha, 410005, China
Completed
Nanjing, 210029, China
Completed
Changchun, 130021, China
Completed
Kunming, 650032, China
Completed
Nanjing, China
Terminated
Jinan, 250012, China
Completed
Shanghai, 200003, China
Completed
Shanghai, 200025, China
Completed
Shanghai, 200092, China
Completed
Shanghai, 200062, China
Completed
Beijing, 100050, China
Completed
Suzhou, 215006, China
Completed
Tianjin, 300121, China
Completed
Tianjin, 300052, China
Completed
Wuhu, 241001, China
Completed
Wuxi, China
Completed
Xi'an, 710061, China
Completed
Urumqi, 830054, China
Completed
Urumchi, 830054, China
Completed
Hangzhou, 310009, China
Terminated
Hangzhou, 310003, China
Completed
Hangzhou, 310014, China
Terminated
Chongqing, 400042, China
Terminated
Chongqing, 400042, China
Completed
Fuzhou, 350025, China
Completed
Shenyang, 110016, China
Terminated
Shenyang, 110001, China
Completed
Changsha, 410013, China
Completed
Changsha, 410013, China
Completed
Quezon City, Philippines
Completed
Taguig City, Philippines
Completed
Xi'an, 710038, China
Completed
Taipei, 10002, Taiwan
Terminated
Taoyuan, 333, Taiwan
Completed
Taichung, 40447, Taiwan
Completed
Tainan, 710, Taiwan
Completed
Kaohsiung, 81362, Taiwan
Completed
Kaohsiung, 807, Taiwan
Completed
Taipei, 116, Taiwan
Completed
Changsha, 410015, China
Completed
Hangzhou, 310016, China
Completed
Shanghai, 201700, China
Completed
Beijing, 100730, China
Completed
Taiyuan, 030001, China
Completed
Shanghai, 201406, China

Primary Outcome

  • Percentage of participants with early clinical response at 48-72 hours after the first infusion of study drug in the ITT analysis set.
    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.
    date_rangeTime Frame:
    Baseline and 48-72 hours visit
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Programmatically defined clinical response at end of therapy (EOT) visit in the ITT analysis set
    Clinical response will be defined as percentage of participants with clinical success, clinical failure or indeterminate.
    date_rangeTime Frame:
    Baseline and EOT visit (Day 11)
    enhanced_encryption
    Safety Issue:
    No
  • Programmatically defined clinical response at end of therapy (EOT) visit in the Clinically Evaluable at EOT (CE-EOT) analysis set
    Clinical response will be defined as percentage of participants with clinical success, clinical failure or indeterminate.
    date_rangeTime Frame:
    Baseline and EOT visit (Day 11)
    enhanced_encryption
    Safety Issue:
    No
  • Overall investigator’s assessment of clinical success at post therapy evaluation (PTE) visit (7-14 days after EOT visit) in the ITT analysis set
    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.
    date_rangeTime Frame:
    Baseline and post-therapy evaluation visit (7-14 days after Day 11)
    enhanced_encryption
    Safety Issue:
    No
  • 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
    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.
    date_rangeTime Frame:
    Baseline and post-therapy evaluation visit (7-14 days after Day 11)
    enhanced_encryption
    Safety Issue:
    No
  • Investigator’s assessment of clinical response 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.
    date_rangeTime Frame:
    Baseline and at 48-72 hours
    enhanced_encryption
    Safety Issue:
    No
  • Investigator’s assessment of clinical response at 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.
    date_rangeTime Frame:
    Baseline and Day 7 visit
    enhanced_encryption
    Safety Issue:
    No
  • Value of the visual analog scale (VAS) pain scores at each time point
    The patient-reported level of pain were assessed by the visual analog scale (VAS) pain score. Using a 10 cm VAS (from no pain to worst pain ever), 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.
    date_rangeTime Frame:
    Up to EOT visit (Day 11)
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in the visual analog scale (VAS) pain scores at each time point
    The patient-reported level of pain were assessed by the visual analog scale (VAS) pain score. Using a 10 cm VAS (from no pain to worst pain ever), 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.
    date_rangeTime Frame:
    Up to EOT visit (Day 11)
    enhanced_encryption
    Safety Issue:
    No
  • Value of the faces rating scale (FRS) pain scores at each time point
    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.
    date_rangeTime Frame:
    Up to EOT visit (Day 11)
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in the faces rating scale (FRS) pain scores at each time point
    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.
    date_rangeTime Frame:
    Up to EOT visit (Day 11)
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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