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
1 other identifier
interventional
598
4 countries
55
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2014
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2014
CompletedFirst Posted
Study publicly available on registry
February 19, 2014
CompletedStudy Start
First participant enrolled
March 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 6, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 18, 2016
CompletedResults Posted
Study results publicly available
June 7, 2017
CompletedJune 7, 2017
May 1, 2017
2 years
February 17, 2014
February 15, 2017
May 5, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline and 48-72 hours visit
Secondary Outcomes (10)
Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the ITT Analysis Set
Baseline and EOT visit (Day 11)
Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the Clinically Evaluable at EOT (CE-EOT) Analysis Set
Baseline and EOT visit (Day 11)
Overall Investigator's Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the ITT Analysis Set
Baseline and post-therapy evaluation visit (7-14 days after Day 11)
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
Baseline and post-therapy evaluation visit (7-14 days after Day 11)
Investigator's Assessment of Clinical Response at 48-72 Hours
Baseline and at 48-72 hours
- +5 more secondary outcomes
Study Arms (2)
Tedizolid Phosphate (Sivextro, BAY119-2631)
EXPERIMENTALParticipants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo.
Linezolid
ACTIVE COMPARATORParticipants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days.
Interventions
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 Linezolid twice daily i.v. to oral from 1-10 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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (55)
Unknown Facility
Chula Vista, California, 91911, United States
Unknown Facility
La Mesa, California, 91942, United States
Unknown Facility
Oceanside, California, 92056, United States
Unknown Facility
Las Vegas, Nevada, 89109, United States
Unknown Facility
Teaneck, New Jersey, 07666, United States
Unknown Facility
Wuhu, Anhui, 241001, China
Unknown Facility
Fuzhou, Fujian, 350025, China
Unknown Facility
Guangzhou, Guangdong, 510120, China
Unknown Facility
Guangzhou, Guangdong, 510180, China
Unknown Facility
Wuhan, Hubei, 430030, China
Unknown Facility
Changsha, Hunan, 410005, China
Unknown Facility
Changsha, Hunan, 410013, China
Unknown Facility
Changsha, Hunan, 410015, China
Unknown Facility
Nanjing, Jiangsu, 210029, China
Unknown Facility
Nanjing, Jiangsu, China
Unknown Facility
Suzhou, Jiangsu, 215006, China
Unknown Facility
Wuxi, Jiangsu, China
Unknown Facility
Changchun, Jilin, 130021, China
Unknown Facility
Dalian, Liaoning, 116027, China
Unknown Facility
Shenyang, Liaoning, 110001, China
Unknown Facility
Shenyang, Liaoning, 110016, China
Unknown Facility
Xi'an, Shaanxi, 710038, China
Unknown Facility
Xi'an, Shaanxi, 710061, China
Unknown Facility
Jinan, Shandong, 250012, China
Unknown Facility
Taiyuan, Shanxi, 030001, China
Unknown Facility
Chengdu, Sichuan, 610041, China
Unknown Facility
Ürümqi, Xinjiang, 830054, China
Unknown Facility
Kunming, Yunnan, 650032, China
Unknown Facility
Hangzhou, Zhejiang, 310003, China
Unknown Facility
Hangzhou, Zhejiang, 310009, China
Unknown Facility
Hangzhou, Zhejiang, 310014, China
Unknown Facility
Hangzhou, Zhejiang, 310016, China
Unknown Facility
Beijing, 100034, China
Unknown Facility
Beijing, 100044, China
Unknown Facility
Beijing, 100050, China
Unknown Facility
Beijing, 100191, China
Unknown Facility
Beijing, 100730, China
Unknown Facility
Chongqing, 400042, China
Unknown Facility
Shanghai, 200003, China
Unknown Facility
Shanghai, 200025, China
Unknown Facility
Shanghai, 200062, China
Unknown Facility
Shanghai, 200092, China
Unknown Facility
Shanghai, 201406, China
Unknown Facility
Shanghai, 201700, China
Unknown Facility
Tianjin, 300052, China
Unknown Facility
Tianjin, 300121, China
Unknown Facility
City of Taguig, Philippines
Unknown Facility
Quezon City, Philippines
Unknown Facility
Kaohsiung City, 807, Taiwan
Unknown Facility
Kaohsiung City, 81362, Taiwan
Unknown Facility
Taichung, 40447, Taiwan
Unknown Facility
Tainan, 710, Taiwan
Unknown Facility
Taipei, 10002, Taiwan
Unknown Facility
Taipei, 116, Taiwan
Unknown Facility
Taoyuan District, 333, Taiwan
Related Publications (1)
Lv X, Alder J, Li L, O'Riordan W, Rybak MJ, Ye H, Zhang R, Zhang Z, Zhu X, Wilcox MH. Efficacy and Safety of Tedizolid Phosphate versus Linezolid in a Randomized Phase 3 Trial in Patients with Acute Bacterial Skin and Skin Structure Infection. Antimicrob Agents Chemother. 2019 Jun 24;63(7):e02252-18. doi: 10.1128/AAC.02252-18. Print 2019 Jul.
PMID: 30988146DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Bayer
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2014
First Posted
February 19, 2014
Study Start
March 4, 2014
Primary Completion
March 6, 2016
Study Completion
April 18, 2016
Last Updated
June 7, 2017
Results First Posted
June 7, 2017
Record last verified: 2017-05