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)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Infections
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2014-02-19
Enrollment: 598
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility 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

Primary outcomes:
measure: Percentage of Participants With Early Clinical Response at 48-72 Hours After the First Infusion of Study Drug in the ITT Analysis Set.
timeFrame: Baseline and 48-72 hours visit
Secondary outcomes:
measure: Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the ITT Analysis Set
timeFrame: Baseline and EOT visit (Day 11)
measure: Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the Clinically Evaluable at EOT (CE-EOT) Analysis Set
timeFrame: Baseline and EOT visit (Day 11)
measure: Overall Investigator's Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the ITT Analysis Set
timeFrame: Baseline and post-therapy evaluation visit (7-14 days after Day 11)
measure: 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
timeFrame: Baseline and post-therapy evaluation visit (7-14 days after Day 11)
measure: Investigator's Assessment of Clinical Response at 48-72 Hours
timeFrame: Baseline and at 48-72 hours
measure: Investigator's Assessment of Clinical Response at Day 7 Visit
timeFrame: Baseline and Day 7 visit
measure: Value of the Visual Analog Scale (VAS) Pain Scores at Each Time Point
timeFrame: Up to EOT visit (Day 11)
measure: Change From Baseline in the Visual Analog Scale (VAS) Pain Scores at Each Time Point
timeFrame: Up to EOT visit (Day 11)
measure: Value of the Faces Rating Scale (FRS) Pain Scores at Each Time Point
timeFrame: Up to EOT visit (Day 11)
measure: Change From Baseline in the Faces Rating Scale (FRS) Pain Scores at Each Time Point
timeFrame: Up to EOT visit (Day 11)
Other outcomes:
Locations:
city: Chula Vista
country: United States
state: California
city: La Mesa
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Las Vegas
country: United States
state: Nevada
city: Teaneck
country: United States
state: New Jersey
city: Wuhu
country: China
state: Anhui
city: Fuzhou
country: China
state: Fujian
city: Guangzhou
country: China
state: Guangdong
city: Guangzhou
country: China
state: Guangdong
city: Wuhan
country: China
state: Hubei
city: Changsha
country: China
state: Hunan
city: Changsha
country: China
state: Hunan
city: Changsha
country: China
state: Hunan
city: Nanjing
country: China
state: Jiangsu
city: Nanjing
country: China
state: Jiangsu
city: Suzhou
country: China
state: Jiangsu
city: Wuxi
country: China
state: Jiangsu
city: Changchun
country: China
state: Jilin
city: Dalian
country: China
state: Liaoning
city: Shenyang
country: China
state: Liaoning
city: Shenyang
country: China
state: Liaoning
city: Xi'an
country: China
state: Shaanxi
city: Xi'an
country: China
state: Shaanxi
city: Jinan
country: China
state: Shandong
city: Taiyuan
country: China
state: Shanxi
city: Chengdu
country: China
state: Sichuan
city: Urumchi
country: China
state: Xinjiang
city: Urumqi
country: China
state: Xinjiang
city: Kunming
country: China
state: Yunnan
city: Hangzhou
country: China
state: Zhejiang
city: Hangzhou
country: China
state: Zhejiang
city: Hangzhou
country: China
state: Zhejiang
city: Hangzhou
country: China
state: Zhejiang
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Chongqing
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Tianjin
country: China
city: Tianjin
country: China
city: Quezon City
country: Philippines
city: Taguig City
country: Philippines
city: Kaohsiung
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Taichung
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.