Phase 3
N=598
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
Bottom Line
View on ClinicalTrials.gov: NCT02066402 ↗Enrolled (actual)
598
Serious AEs
3.2%
Results posted
Jun 2017
Primary outcome: Primary: Percentage of Participants With Early Clinical Response at 48-72 Hours After the First Infusion of Study Drug in the ITT Analysis Set. — 75.3; 79.9 Percentage of participants — p=0.2027
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tedizolid (BAY119-2631) (Drug); Placebo Tedizolid (BAY119-2631) (Drug); Linezolid (Drug); Placebo Linezolid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Early Clinical Response at 48-72 Hours After the First Infusion of Study Drug in the ITT Analysis Set. |
75.3; 79.9 | 0.2027 |
| SECONDARY Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the ITT Analysis Set |
82.0; 84.2; 18.0; 15.8 | — |
| SECONDARY Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the Clinically Evaluable at EOT (CE-EOT) Analysis Set |
89.7; 91.8; 10.3; 8.2 | — |
| SECONDARY Overall Investigator's Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the ITT Analysis Set |
79.7; 81.9; 20.3; 18.1 | — |
| SECONDARY 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 |
90.4; 93.5; 9.6; 6.5 | — |
| SECONDARY Investigator's Assessment of Clinical Response at 48-72 Hours |
86.7; 90.3; 4.7; 3.0; 0.7; 0.0 | — |
| SECONDARY Investigator's Assessment of Clinical Response at Day 7 Visit |
88.3; 87.6; 0.3; 0.3; 11.3; 12.1 | — |
| SECONDARY Value of the Visual Analog Scale (VAS) Pain Scores at Each Time Point |
40.9; 40.1; 30.2; 30.7; 18.8; 17.8 | — |
| SECONDARY Change From Baseline in the Visual Analog Scale (VAS) Pain Scores at Each Time Point |
-12.5; -13.8; -23.2; -23.2; -34.7; -36.1 | — |
| SECONDARY Value of the Faces Rating Scale (FRS) Pain Scores at Each Time Point |
4.1; 4.2; 3.2; 3.2; 2.1; 2.0 | — |
| SECONDARY Change From Baseline in the Faces Rating Scale (FRS) Pain Scores at Each Time Point |
-1.5; -1.5; -2.4; -2.4; -3.5; -3.6 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02066402). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.