Study Completed

Bacterial Infections

Bayer Identifier:

16121

ClinicalTrials.gov Identifier:

NCT02066402

EudraCT Number:

Not Available

EU CT Number:

Not Available

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)

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A

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 summary

Enrollment Goal

598

Trial Dates

March 2014 - April 2016

Phase

Phase 3

Could I Receive a placebo

Yes

Products

Sivextro (Tedizolid phosphate, BAY119-2631)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Las Vegas, 89109, United States
Completed		Oceanside, 92056, United States
Completed		Teaneck, 07666, United States
Completed		La Mesa, 91942, United States
Completed		Chula Vista, 91911, United States
Completed		Chengdu, 610041, China
Completed		Chengdu, 610041, China
Completed		Beijing, 100191, China
Terminated		Beijing, 100034, China
Terminated		Beijing, 100044, China
Terminated		Beijing, 100044, China
Completed		Beijing, 100730, China
Completed		Dalian, 116027, China
Completed		Guangzhou, 510180, China
Completed		Guangzhou, 510120, China
Completed		Wuhan, 430030, China
Completed		Changsha, 410005, China
Completed		Nanjing, 210029, China
Completed		Changchun, 130021, China
Completed		Kunming, 650032, China
Completed		Nanjing, China
Terminated		Jinan, 250012, China
Completed		Shanghai, 200003, China
Completed		Shanghai, 200025, China
Completed		Shanghai, 200092, China
Completed		Shanghai, 200062, China
Completed		Beijing, 100050, China
Completed		Suzhou, 215006, China
Completed		Tianjin, 300121, China
Completed		Tianjin, 300052, China
Completed		Wuhu, 241001, China
Completed		Wuxi, China
Completed		Xi'an, 710061, China
Completed		Urumqi, 830054, China
Completed		Urumchi, 830054, China
Completed		Hangzhou, 310009, China
Terminated		Hangzhou, 310003, China
Completed		Hangzhou, 310014, China
Terminated		Chongqing, 400042, China
Terminated		Chongqing, 400042, China
Completed		Fuzhou, 350025, China
Completed		Shenyang, 110016, China
Terminated		Shenyang, 110001, China
Completed		Changsha, 410013, China
Completed		Changsha, 410013, China
Completed		Quezon City, Philippines
Completed		Taguig City, Philippines
Completed		Xi'an, 710038, China
Completed		Taipei, 10002, Taiwan
Terminated		Taoyuan, 333, Taiwan
Completed		Taichung, 40447, Taiwan
Completed		Tainan, 710, Taiwan
Completed		Kaohsiung, 81362, Taiwan
Completed		Kaohsiung, 807, Taiwan
Completed		Taipei, 116, Taiwan
Completed		Changsha, 410015, China
Completed		Hangzhou, 310016, China
Completed		Shanghai, 201700, China
Completed		Beijing, 100730, China
Completed		Taiyuan, 030001, China
Completed		Shanghai, 201406, China

Primary Outcome

Percentage of participants with early clinical response at 48-72 hours after the first infusion of study drug in the ITT analysis set.
Early clinical response is defined as responder if there is >=20% reduction in the area of erythema, edema, and/or induration (length × width) of the primary acute bacterial skin and skin structure infections (ABSSSI) lesion, compared with baseline at the 48-72 Hour visit.
Time Frame:
Baseline and 48-72 hours visit
Safety Issue:
No

Secondary Outcome

Programmatically defined clinical response at end of therapy (EOT) visit in the ITT analysis set
Clinical response will be defined as percentage of participants with clinical success, clinical failure or indeterminate.
Time Frame:
Baseline and EOT visit (Day 11)
Safety Issue:
No
Programmatically defined clinical response at end of therapy (EOT) visit in the Clinically Evaluable at EOT (CE-EOT) analysis set
Clinical response will be defined as percentage of participants with clinical success, clinical failure or indeterminate.
Time Frame:
Baseline and EOT visit (Day 11)
Safety Issue:
No
Overall investigator’s assessment of clinical success at post therapy evaluation (PTE) visit (7-14 days after EOT visit) in the ITT analysis set
The Investigator made an assessment of clinical response at the PTE Visit (7-14 days after the EOT Visit +2 days). Participants assessed as a clinical failure at the EOT Visit are considered a clinical failure at the PTE Visit. Percentage of participants with clinical success, clinical failure or indeterminate were reported.
Time Frame:
Baseline and post-therapy evaluation visit (7-14 days after Day 11)
Safety Issue:
No
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
The Investigator made an assessment of clinical response at the PTE Visit (7-14 days after the EOT Visit +2 days). Participants assessed as a clinical failure at the EOT Visit are considered a clinical failure at the PTE Visit. Percentage of participants with clinical success, clinical failure or indeterminate were reported.
Time Frame:
Baseline and post-therapy evaluation visit (7-14 days after Day 11)
Safety Issue:
No
Investigator’s assessment of clinical response at 48-72 hours
The Investigator made an assessment of clinical response at the 48-72 Hour Visit based on following definition: Improving (Improvement in overall clinical status of ABSSSI compatible with continuation of study drug therapy); Stable (Signs and symptoms stable, no apparent change in overall clinical status but compatible with continuation of study drug therapy); Other.
Time Frame:
Baseline and at 48-72 hours
Safety Issue:
No
Investigator’s assessment of clinical response at Day 7 visit
The Investigator made an assessment of clinical response at Day 7 Visit based on following definition: Improving (Improvement in overall clinical status of ABSSSI compatible with continuation of study drug therapy); Other.
Time Frame:
Baseline and Day 7 visit
Safety Issue:
No
Value of the visual analog scale (VAS) pain scores at each time point
The patient-reported level of pain were assessed by the visual analog scale (VAS) pain score. Using a 10 cm VAS (from no pain to worst pain ever), instruct the patient to indicate the point along the line that represents the pain they are feeling. Once the patient indicates how much pain they are feeling, measure the distance from no pain and enter the value.
Time Frame:
Up to EOT visit (Day 11)
Safety Issue:
No
Change from baseline in the visual analog scale (VAS) pain scores at each time point
The patient-reported level of pain were assessed by the visual analog scale (VAS) pain score. Using a 10 cm VAS (from no pain to worst pain ever), instruct the patient to indicate the point along the line that represents the pain they are feeling. Once the patient indicates how much pain they are feeling, measure the distance from no pain and enter the value.
Time Frame:
Up to EOT visit (Day 11)
Safety Issue:
No
Value of the faces rating scale (FRS) pain scores at each time point
The patient-reported level of pain were assessed by the faces rating scale (FRS) pain score. Ask the patient to rate their pain from 0 to 10 with 0 being no pain at all and 10 being the worst pain then enter the numerical value.
Time Frame:
Up to EOT visit (Day 11)
Safety Issue:
No
Change from baseline in the faces rating scale (FRS) pain scores at each time point
The patient-reported level of pain were assessed by the faces rating scale (FRS) pain score. The patient-reported level of pain were assessed by the faces rating scale (FRS) pain score. Ask the patient to rate their pain from 0 to 10 with 0 being no pain at all and 10 being the worst pain then enter the numerical value.
Time Frame:
Up to EOT visit (Day 11)
Safety Issue:
No

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Double Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

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