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)

Bacterial Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02066402
• Other study ID #: 16121
• Status: Completed
• Phase: Phase 3
• First received: February 17, 2014
• Last updated: May 6, 2016
• Start date: March 2014
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationPhilippines : Food and Drug AdministrationTaiwan: Taiwan Floriculture Development AssociationUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

ABSSSI Efficacy Safety Tedizolid Phosphate Linezolid

Recruitment information / eligibility

• Status: Completed
• Enrollment: 598
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Infections
• Infection

Intervention

Drug:
• 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
• 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
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  China,  Philippines,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early Clinical Response	Percentage of participants with early clinical response (defined as responder if there is = 20% reduction from baseline in the area of erythema, edema, and/or induration from baseline of the primary acute bacterial skin and skin structure infections [ ABSSSI ] lesion)	48-72 hours after baseline	No
Secondary	Clinical response at the End of Treatment (EOT) Visit	Clinical response as per protocol will be evaluated as either Clinical Success,Clinical failure or Indeterminate	11 days after baseline	No
Secondary	Investigator's assessment of clinical success at the Post Therapy Evaluation (PTE) Visit		7-14 days after End of Treatment	No
Secondary	Investigator's assessment of clinical response at the 48-72 hours visit	Investigator's assessment of clinical response will be evaluated as either Improving, Stable or Clinical Failure	48-72 hour after baseline	No
Secondary	Investigator's assessment of clinical response at the 7 day visit	Investigator's assessment of clinical response will be evaluated as either Improving or Clinical Failure	7 days after baseline	No
Secondary	Change from baseline in the pain scores	Visual Analog Scale (VAS) and Wong-Baker Faces Rating Scale (FRS) will be used to access intensity of pain experienced	Up to 36 days after baseline	No
Secondary	Number of participants with adverse events as a measure of safety and tolerability		Up to 36 days after baseline	Yes

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