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)

NCT ID: NCT02066402

Last Updated: 2017-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 598 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-04
• Study Completion Date: 2016-04-18

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

Conditions

Bacterial Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Tedizolid (BAY119-2631)

Intervention Type: DRUG

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

Placebo Tedizolid (BAY119-2631)

Intervention Type: DRUG

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

Placebo Linezolid

Intervention Type: DRUG

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

Linezolid

Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days.

Group Type: ACTIVE_COMPARATOR

Placebo Tedizolid (BAY119-2631)

Intervention Type: DRUG

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

Linezolid

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Chula Vista, California, United States

La Mesa, California, United States

Oceanside, California, United States

Las Vegas, Nevada, United States

Teaneck, New Jersey, United States

Wuhu, Anhui, China

Fuzhou, Fujian, China

Guangzhou, Guangdong, China

Guangzhou, Guangdong, China

Wuhan, Hubei, China

Changsha, Hunan, China

Changsha, Hunan, China

Changsha, Hunan, China

Nanjing, Jiangsu, China

Nanjing, Jiangsu, China

Suzhou, Jiangsu, China

Wuxi, Jiangsu, China

Changchun, Jilin, China

Dalian, Liaoning, China

Shenyang, Liaoning, China

Shenyang, Liaoning, China

Xi'an, Shaanxi, China

Xi'an, Shaanxi, China

Jinan, Shandong, China

Taiyuan, Shanxi, China

Chengdu, Sichuan, China

Ürümqi, Xinjiang, China

Kunming, Yunnan, China

Hangzhou, Zhejiang, China

Hangzhou, Zhejiang, China

Hangzhou, Zhejiang, China

Hangzhou, Zhejiang, China

Beijing, , China

Beijing, , China

Beijing, , China

Beijing, , China

Beijing, , China

Chongqing, , China

Shanghai, , China

Shanghai, , China

Shanghai, , China

Shanghai, , China

Shanghai, , China

Shanghai, , China

Tianjin, , China

Tianjin, , China

City of Taguig, , Philippines

Quezon City, , Philippines

Kaohsiung City, , Taiwan

Kaohsiung City, , Taiwan

Taichung, , Taiwan

Tainan City, , Taiwan

Taipei, , Taiwan

Taipei, , Taiwan

Taoyuan District, , Taiwan

Countries

United States; China; Philippines; Taiwan

References

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.

Reference Type: DERIVED

PMID: 30988146 (View on PubMed)

Other Identifiers

16121

Identifier Type: -

Identifier Source: org_study_id