- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02066402
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)
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Beijing, China, 100044
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Beijing, China, 100050
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Beijing, China, 100730
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Beijing, China, 100034
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Beijing, China, 100191
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Chongqing, China, 400042
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Shanghai, China, 200025
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Shanghai, China, 200003
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Shanghai, China, 200092
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Shanghai, China, 200062
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Shanghai, China, 201406
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Shanghai, China, 201700
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Tianjin, China, 300052
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Tianjin, China, 300121
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Anhui
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Wuhu, Anhui, China, 241001
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Fujian
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Fuzhou, Fujian, China, 350025
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Guangdong
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Guangzhou, Guangdong, China, 510120
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Guangzhou, Guangdong, China, 510180
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Hubei
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Wuhan, Hubei, China, 430030
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Hunan
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Changsha, Hunan, China, 410013
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Changsha, Hunan, China, 410005
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Changsha, Hunan, China, 410015
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Jiangsu
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Nanjing, Jiangsu, China
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Nanjing, Jiangsu, China, 210029
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Suzhou, Jiangsu, China, 215006
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Wuxi, Jiangsu, China
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Jilin
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Changchun, Jilin, China, 130021
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Liaoning
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Dalian, Liaoning, China, 116027
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Shenyang, Liaoning, China, 110001
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Shenyang, Liaoning, China, 110016
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Shaanxi
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Xi'an, Shaanxi, China, 710061
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Xi'an, Shaanxi, China, 710038
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Shandong
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Jinan, Shandong, China, 250012
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Shanxi
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Taiyuan, Shanxi, China, 030001
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Sichuan
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Chengdu, Sichuan, China, 610041
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Xinjiang
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Urumchi, Xinjiang, China, 830054
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Urumqi, Xinjiang, China, 830054
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Yunnan
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Kunming, Yunnan, China, 650032
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Zhejiang
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Hangzhou, Zhejiang, China, 310003
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Hangzhou, Zhejiang, China, 310016
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Hangzhou, Zhejiang, China, 310009
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Hangzhou, Zhejiang, China, 310014
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Quezon City, Philippines
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Taguig City, Philippines
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Kaohsiung, Taiwan, 807
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Kaohsiung, Taiwan, 81362
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Taichung, Taiwan, 40447
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Tainan, Taiwan, 710
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Taipei, Taiwan, 116
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Taipei, Taiwan, 10002
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Taoyuan, Taiwan, 333
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California
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Chula Vista, California, United States, 91911
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La Mesa, California, United States, 91942
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Oceanside, California, United States, 92056
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Nevada
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Las Vegas, Nevada, United States, 89109
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New Jersey
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Teaneck, New Jersey, United States, 07666
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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
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
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
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Active Comparator: Linezolid
Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days.
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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
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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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.
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Baseline and 48-72 hours visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the ITT Analysis Set
Time Frame: Baseline and EOT visit (Day 11)
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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.
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Baseline and EOT visit (Day 11)
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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)
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Clinical response will be defined as percentage of participants with clinical success, clinical failure or indeterminate.
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Baseline and EOT visit (Day 11)
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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)
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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.
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Baseline and post-therapy evaluation visit (7-14 days after Day 11)
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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)
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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.
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Baseline and post-therapy evaluation visit (7-14 days after Day 11)
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Investigator's Assessment of Clinical Response at 48-72 Hours
Time Frame: Baseline and at 48-72 hours
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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.
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Baseline and at 48-72 hours
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Investigator's Assessment of Clinical Response at Day 7 Visit
Time Frame: Baseline and Day 7 visit
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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.
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Baseline and Day 7 visit
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Value of the Visual Analog Scale (VAS) Pain Scores at Each Time Point
Time Frame: Up to EOT visit (Day 11)
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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.
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Up to EOT visit (Day 11)
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Change From Baseline in the Visual Analog Scale (VAS) Pain Scores at Each Time Point
Time Frame: Up to EOT visit (Day 11)
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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.
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Up to EOT visit (Day 11)
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Value of the Faces Rating Scale (FRS) Pain Scores at Each Time Point
Time Frame: Up to EOT visit (Day 11)
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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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Up to EOT visit (Day 11)
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Change From Baseline in the Faces Rating Scale (FRS) Pain Scores at Each Time Point
Time Frame: Up to EOT visit (Day 11)
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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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Up to EOT visit (Day 11)
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16121
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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