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)

Bayer

Status and phase: Completed; Phase 3

Conditions: Bacterial Infections

Treatments: Drug: Placebo Tedizolid (BAY119-2631); Drug: Linezolid; Drug: Tedizolid (BAY119-2631); Drug: Placebo Linezolid

Study type: Interventional

Funder types: Industry

Identifiers

NCT02066402

16121

Details and patient eligibility

About

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.

Full 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

Enrollment: 598 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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598 participants in 2 patient groups

Tedizolid Phosphate (Sivextro, BAY119-2631)

Experimental group

Description:

Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo.

Treatment:

Drug: Placebo Linezolid

Drug: Placebo Tedizolid (BAY119-2631)

Drug: Tedizolid (BAY119-2631)

Linezolid

Active Comparator group

Description:

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

Treatment:

Drug: Placebo Tedizolid (BAY119-2631)

Drug: Linezolid