Clinical Trials List
Protocol NumberBAY 119-2631 (formerly 117-0438)/16121
2013-11-01 - 2016-06-20
Phase III
Study ended7
ICD-10T86.822
Skin graft (allograft) (autograft) infection
ICD-10L56.8
Other specified acute skin changes due to ultraviolet radiation
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 Applicant
BAYER TAIWAN COMPANY LTD.
-
Sponsor
Bayer
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- SUNG-CHING PAN Division of Infectious Disease
- Jann-Tay Wang Division of Infectious Disease
- 陳世英 Division of Infectious Disease
- 黃崧溪 Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Study ended
Principal Investigator
Co-Principal Investigator
- Po-Chang Lin Division of Infectious Disease
- Jen-Hsien Wang Division of Infectious Disease
- Ho Mao-Wang Division of Infectious Disease
- 林伯昌 Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Study ended
Co-Principal Investigator
- Te-Fa Chiu Division of Emergency Medicine
- 黃集仁 Division of Emergency Medicine
- 王醫林 Division of Emergency Medicine
The Actual Total Number of Participants Enrolled
0 Study ended
Co-Principal Investigator
- Yin-Ching Chuang Division of Infectious Disease
- Wei-Ting Chang Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Study ended
The Actual Total Number of Participants Enrolled
0 Study ended
Co-Principal Investigator
- Po-Liang Lu Division of Infectious Disease
- Chun-Yu Lin Division of Infectious Disease
- Chung-Hao Huang Division of Infectious Disease
- 林蔚如 Division of Infectious Disease
- 賴宗志 Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Study ended
Co-Principal Investigator
- Fu-Lun Chen Division of Infectious Disease
- Tsong-Yih Ou Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Study ended
Condition/Disease
Acute Bacterial Skin and SkinStructure Infections
Objectives
The primary objective is to determine the non-inferiority (NI) in the early clinical response
rate of intravenous (I.V.) to oral 6-day Tedizolid Phosphate compared with that of I.V. to oral
10-day Linezolid treatment at 48-72 hours after the first infusion of study drug in the intentto-treat (ITT) analysis set in patients with acute bacterial skin and skin structure infections
(ABSSSI).
The secondary objectives are:
To compare the programmatic clinical response of I.V. to oral 6-day Tedizolid
Phosphate treatment and I.V. to oral 10-day Linezolid treatment at the end of
therapy (EOT) Visit (Day 11) in the ITT and Clinically Evaluable at EOT
(CE-EOT) analysis sets
To compare the Investigator’s assessment of clinical success at the post-therapy
evaluation (PTE) Visit (7-14 days after the EOT Visit) in the ITT and Clinically
Evaluable at PTE (CE-PTE) analysis sets
To compare the Investigator’s assessment of clinical response at the 48-72 Hour and
Day 7 Visits in the ITT analysis set
To compare patient-reported pain, by study visit
To evaluate the safety profile of I.V. to oral Tedizolid Phosphate in comparison with
that of I.V. to oral Linezolid
The additional objectives are:
To compare the per-patient favorable microbiological response rate at the PTE Visit
in the Microbiological ITT (MITT) and microbiologically evaluable (ME) analysis
sets
To compare the per-pathogen favorable microbiological response rate at the PTE
Visit in the MITT and ME analysis sets
To compare the Investigator’s assessment of clinical success at the PTE Visit in the
MITT and ME analysis sets
To compare the per-pathogen Investigator’s assessment of clinical success at the
PTE Visit in the MITT and ME analysis sets
Test Drug
Tedizolid Phosphate
Active Ingredient
Tedizolid Phosphate
Dosage Form
Injection
Dosage
200 mg
Endpoints
Primary efficacy outcome
The primary efficacy outcome is the early clinical response rate at 48-72 hours after the first
infusion of study drug in the ITT analysis set. Early clinical
response (responder [≥20% reduction from baseline in the area of erythema, edema, and/or
induration from baseline of the primary ABSSSI lesion] and nonresponders) will be
determined programmatically from lesion area measurements recorded on the electronic case
report form (e-CRF).
Secondary efficacy outcomes
Secondary outcome measures are the following:
♦ Clinical response at the EOT Visit in the ITT and CE-EOT analysis sets
♦ Investigator’s assessment of clinical success at the PTE Visit in the ITT
and CE-PTE analysis sets. Patients assessed as a clinical failure at the
EOT Visit are considered a clinical failure at the PTE Visit
♦ Investigator’s assessment of clinical response at the 48-72 Hour and Day
7 Visits
♦ Change from baseline in the pain scores at each time point
Additional efficacy outcomes
♦ Change from baseline in lesion size, assessment of local signs and
symptoms, and regional or systemic signs (lymphadenopathy,
temperature, percentage immature neutrophils, WBC count)
♦ Per-patient favorable (eradication or presumed eradication)
microbiological response at the PTE Visit in the MITT and ME analysis
set. Per-patient microbiological response is based on per-pathogen
outcomes
♦ Per-pathogen microbiological response at the PTE Visit in the MITT and
ME analysis sets
♦ Investigator’s assessment of clinical success at the PTE Visit in the MITT
and ME analysis sets
♦ Per-pathogen Investigator’s assessment of clinical success at the PTE
Visit in the MITT and ME analysis sets
The primary efficacy outcome is the early clinical response rate at 48-72 hours after the first
infusion of study drug in the ITT analysis set. Early clinical
response (responder [≥20% reduction from baseline in the area of erythema, edema, and/or
induration from baseline of the primary ABSSSI lesion] and nonresponders) will be
determined programmatically from lesion area measurements recorded on the electronic case
report form (e-CRF).
Secondary efficacy outcomes
Secondary outcome measures are the following:
♦ Clinical response at the EOT Visit in the ITT and CE-EOT analysis sets
♦ Investigator’s assessment of clinical success at the PTE Visit in the ITT
and CE-PTE analysis sets. Patients assessed as a clinical failure at the
EOT Visit are considered a clinical failure at the PTE Visit
♦ Investigator’s assessment of clinical response at the 48-72 Hour and Day
7 Visits
♦ Change from baseline in the pain scores at each time point
Additional efficacy outcomes
♦ Change from baseline in lesion size, assessment of local signs and
symptoms, and regional or systemic signs (lymphadenopathy,
temperature, percentage immature neutrophils, WBC count)
♦ Per-patient favorable (eradication or presumed eradication)
microbiological response at the PTE Visit in the MITT and ME analysis
set. Per-patient microbiological response is based on per-pathogen
outcomes
♦ Per-pathogen microbiological response at the PTE Visit in the MITT and
ME analysis sets
♦ Investigator’s assessment of clinical success at the PTE Visit in the MITT
and ME analysis sets
♦ Per-pathogen Investigator’s assessment of clinical success at the PTE
Visit in the MITT and ME analysis sets
Inclution Criteria
1. Males or females ≥ 18 years old
2. Adequate venous access for a minimum of 2 I.V. doses of study drug
3. 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
a. Cellulitis/erysipelas defined as a diffuse skin infection, characterized by all of the
following within 24 hours:
• Rapidly spreading areas of erythema, edema, and/or induration of a minimum total
lesion surface area of 75 cm2
• No collection of pus apparent upon visual examination (diagnosis still consistent
with cellulitis/erysipelas if pus is collected from the lesion)
• At least 2 of the following signs of infection:
- Erythema
- Induration
- Localized warmth
- Pain or tenderness on palpation
- Swelling/edema
• At least 1 of the following regional or systemic signs of infection:
- Lymph node tenderness and increase in volume or palpable proximal to the
primary ABSSSI
- Fever, defined as body temperature ≥ 38°C (100.4°F) oral, ≥ 38.5°C (101.3°F)
tympanic, or ≥ 39°C (102.2°F) rectal (observed by a health care provider)
- WBC count ≥ 10,000 cells/mm3
or < 4,000 cells/mm3
- >10% immature neutrophils
b. Major cutaneous abscess defined as an infection characterized by a collection of pus
apparent upon visual examination spreading within the dermis or deeper that is
accompanied by all of the following within 24 hours:
• Erythema, edema, and/or induration extending at least 5 cm in the shortest distance
from the peripheral margin of the abscess and with a minimum total lesion surface
area of 75 cm2
• At least 1 of the following signs of infection:
- Fluctuance
- Incision and drainage required
- Purulent or seropurulent drainage
- Localized warmth
- Pain or tenderness on palpation
• At least 1 of the following regional or systemic signs of infection:
- Lymph node tenderness and increase in volume or palpable proximal to the
primary ABSSSI
- Fever, defined as body temperature ≥ 38°C (100.4°F) oral, ≥ 38.5°C (101.3°F)
tympanic, or ≥ 39°C (102.2°F) rectal (observed by a health care provider)
- WBC count ≥ 10,000 cells/mm3
or < 4,000 cells/mm3
- > 10% immature neutrophils
c. Wound Infection defined as an infection of any apparent break in the skin characterized
by the following:
• Superficial incision surgical site infection meeting all of the following criteria:
- Follows clean surgery (elective, not emergency, nontraumatic, primarily closed,
no acute inflammation; no break in technique; respiratory, gastrointestinal,
biliary, and genitourinary tracts not entered)
- Involves only the skin or subcutaneous tissue around the incision, does not
involve fascia
- Occurs within 30 days after procedure
- Original surgical incision ≥ 3 cm
- Purulent drainage (spontaneous or therapeutic) with surrounding erythema,
edema, and/or induration extending at least 5 cm in the shortest distance from
the peripheral margin of the wound and with a minimum total lesion surface area
of 75 cm2
- At least 1 of the following regional or systemic signs of infection:
Lymph node tenderness and increase in volume or palpable proximal to the
primary ABSSSI
Fever, defined as body temperature ≥ 38°C (100.4°F) oral, ≥ 38.5°C
(101.3°F) tympanic, or ≥ 39°C (102.2°F) rectal (observed by a health care
provider)
WBC count ≥ 10,000 cells/mm3
or < 4000 cells/mm3
10% immature neutrophils
• Post-traumatic wound (including penetrating trauma [needle, nail, knife])
characterized by all of the following within 24 hours:
- Purulent drainage (spontaneous or therapeutic) with surrounding erythema,
edema, and/or induration extending at least 5 cm in the shortest distance from
the peripheral margin of the wound and with a minimum total lesion surface area
of 75 cm2
- At least 1 of the following regional or systemic signs of infection:
Lymph node tenderness and increase in volume or palpable proximal to the
primary ABSSSI
Fever, defined as body temperature ≥ 38°C (100.4°F) oral, ≥ 38.5°C
(101.3°F) tympanic, or ≥ 39°C (102.2°F) rectal (observed by a health care
provider)
WBC count ≥ 10,000 cells/mm3
or < 4000 cells/mm3
10% immature neutrophils
4. Suspected or documented gram-positive infection from baseline Gram stain or culture. The
microbiological sample must have been collected using a valid sampling technique such as
an aspirate, biopsy, incision, deep swab, etc. A superficial swab is not acceptable.
Specimens for culture are required for abscesses and wounds at Screening; cellulitis
specimens are to be collected according to standard practice at the site.
5. Able to give written informed consent and willing to comply with all required study
procedures
6. Women of childbearing potential and men must agree to use adequate contraception when
sexually active. This applies since signing of the informed consent form until 7 days after
the last study drug administration. The definition of adequate contraception will be based on
the judgment of the investigator.
2. Adequate venous access for a minimum of 2 I.V. doses of study drug
3. 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
a. Cellulitis/erysipelas defined as a diffuse skin infection, characterized by all of the
following within 24 hours:
• Rapidly spreading areas of erythema, edema, and/or induration of a minimum total
lesion surface area of 75 cm2
• No collection of pus apparent upon visual examination (diagnosis still consistent
with cellulitis/erysipelas if pus is collected from the lesion)
• At least 2 of the following signs of infection:
- Erythema
- Induration
- Localized warmth
- Pain or tenderness on palpation
- Swelling/edema
• At least 1 of the following regional or systemic signs of infection:
- Lymph node tenderness and increase in volume or palpable proximal to the
primary ABSSSI
- Fever, defined as body temperature ≥ 38°C (100.4°F) oral, ≥ 38.5°C (101.3°F)
tympanic, or ≥ 39°C (102.2°F) rectal (observed by a health care provider)
- WBC count ≥ 10,000 cells/mm3
or < 4,000 cells/mm3
- >10% immature neutrophils
b. Major cutaneous abscess defined as an infection characterized by a collection of pus
apparent upon visual examination spreading within the dermis or deeper that is
accompanied by all of the following within 24 hours:
• Erythema, edema, and/or induration extending at least 5 cm in the shortest distance
from the peripheral margin of the abscess and with a minimum total lesion surface
area of 75 cm2
• At least 1 of the following signs of infection:
- Fluctuance
- Incision and drainage required
- Purulent or seropurulent drainage
- Localized warmth
- Pain or tenderness on palpation
• At least 1 of the following regional or systemic signs of infection:
- Lymph node tenderness and increase in volume or palpable proximal to the
primary ABSSSI
- Fever, defined as body temperature ≥ 38°C (100.4°F) oral, ≥ 38.5°C (101.3°F)
tympanic, or ≥ 39°C (102.2°F) rectal (observed by a health care provider)
- WBC count ≥ 10,000 cells/mm3
or < 4,000 cells/mm3
- > 10% immature neutrophils
c. Wound Infection defined as an infection of any apparent break in the skin characterized
by the following:
• Superficial incision surgical site infection meeting all of the following criteria:
- Follows clean surgery (elective, not emergency, nontraumatic, primarily closed,
no acute inflammation; no break in technique; respiratory, gastrointestinal,
biliary, and genitourinary tracts not entered)
- Involves only the skin or subcutaneous tissue around the incision, does not
involve fascia
- Occurs within 30 days after procedure
- Original surgical incision ≥ 3 cm
- Purulent drainage (spontaneous or therapeutic) with surrounding erythema,
edema, and/or induration extending at least 5 cm in the shortest distance from
the peripheral margin of the wound and with a minimum total lesion surface area
of 75 cm2
- At least 1 of the following regional or systemic signs of infection:
Lymph node tenderness and increase in volume or palpable proximal to the
primary ABSSSI
Fever, defined as body temperature ≥ 38°C (100.4°F) oral, ≥ 38.5°C
(101.3°F) tympanic, or ≥ 39°C (102.2°F) rectal (observed by a health care
provider)
WBC count ≥ 10,000 cells/mm3
or < 4000 cells/mm3
10% immature neutrophils
• Post-traumatic wound (including penetrating trauma [needle, nail, knife])
characterized by all of the following within 24 hours:
- Purulent drainage (spontaneous or therapeutic) with surrounding erythema,
edema, and/or induration extending at least 5 cm in the shortest distance from
the peripheral margin of the wound and with a minimum total lesion surface area
of 75 cm2
- At least 1 of the following regional or systemic signs of infection:
Lymph node tenderness and increase in volume or palpable proximal to the
primary ABSSSI
Fever, defined as body temperature ≥ 38°C (100.4°F) oral, ≥ 38.5°C
(101.3°F) tympanic, or ≥ 39°C (102.2°F) rectal (observed by a health care
provider)
WBC count ≥ 10,000 cells/mm3
or < 4000 cells/mm3
10% immature neutrophils
4. Suspected or documented gram-positive infection from baseline Gram stain or culture. The
microbiological sample must have been collected using a valid sampling technique such as
an aspirate, biopsy, incision, deep swab, etc. A superficial swab is not acceptable.
Specimens for culture are required for abscesses and wounds at Screening; cellulitis
specimens are to be collected according to standard practice at the site.
5. Able to give written informed consent and willing to comply with all required study
procedures
6. Women of childbearing potential and men must agree to use adequate contraception when
sexually active. This applies since signing of the informed consent form until 7 days after
the last study drug administration. The definition of adequate contraception will be based on
the judgment of the investigator.
Exclusion Criteria
1. Uncomplicated skin and skin structure infections such as furuncles, minor abscesses (area of
suppuration not surrounded by cellulitis/erysipelas), impetiginous lesions, superficial or
limited cellulitis/erysipelas, and minor wound infections (eg, stitch abscesses)
2. Infections associated with, or in close proximity to, a prosthetic device
3. Severe sepsis or septic shock
4. Known bacteremia at time of screening
5. 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 (i.e., necrotizing fasciitis)
• Infected human or animal bites. However, subjects with arthropod (e.g., insects, spiders,
‘bugs’) bites can be included since these are not considered animal bites in this study3
• Infections at vascular catheter sites or involving thrombophlebitis
• Incision surgical site infection with any of the following characteristics:
- Follows clean-contaminated surgery (urgent or emergency case that is otherwise
clean, elective opening of respiratory, gastrointestinal, biliary, or genitourinary tract
with minimal spillage [eg, appendectomy] not encountering infected urine or bile;
minor technique break)
- Follows contaminated surgery (nonpurulent inflammation; gross spillage from
gastrointestinal tract; entry into biliary or genitourinary tract in the presence of
infected bile or urine; major break in technique; chronic open wounds to be grafted
or covered)
- Follows dirty surgery (purulent inflammation [eg, abscess]; preoperative perforation
of respiratory, gastrointestinal, biliary, or genitourinary tract)
- Extends into the fascia or muscle layers, organs, or spaces
6. 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
7. Administration of Linezolid within 30 days before the first infusion of the study drug
8. Recent history of opportunistic infections where the underlying cause of these infections is
still active (eg, leukemia, transplant, acquired immunodeficiency syndrome [AIDS])
9. Receiving chronic systemic immunosuppressive therapy such as prednisone doses ≥ 20 mg
per day for ≥ 3 of the last 12 months OR therapies that in the Investigator’s judgment could
predispose to opportunistic infections
10. Chronic (daily for the previous 30 days) use of antipyretic medication (eg, acetaminophen,
paracetamol, nonsteroidal anti-inflammatory drugs [NSAIDs]). Low-dose aspirin (≤ 200
mg per day) for cardiovascular prophylaxis is allowed
11. Receiving treatment for active tuberculosis
12. Last known CD4 count < 200 cells/mm3
in patients with AIDS
13. Current or anticipated neutropenia with absolute neutrophil count (ANC) < 1000 cells/mm3
14. Severe renal disease defined as creatinine clearance (CrCl) < 30 mL/min estimated by the
Cockcroft-Gault formula OR requirement for peritoneal dialysis, plasmapheresis,
hemodialysis, venovenous dialysis, or other forms of renal filtration
15. ALT (alanine aminotransferase) or AST (aspartate aminotransferase) ≥ 5 upper limit of
normal OR moderate to severe hepatic disease with Child-Pugh score ≥7 defined by the
following:
• Presence of ascites upon examination
• Evidence of encephalopathy upon examination
• Total bilirubin ≥ 2 mg/dL
• Serum albumin ≤ 3.5 g/dL
• Prothrombin time (PT) ≥ 4 seconds longer than control, or international normalized ratio
(INR) ≥ 1.7
To calculate the Child-Pugh score, see section 7.1.2.1
16. Significant or life-threatening condition or organ or system condition or disease
(eg, endocarditis, meningitis, unstable CNS conditions, acidosis or history of lactic
acidosis) that would confound or interfere with the assessment of the ABSSSI
17. ECG finding of corrected QT interval > 500 msec using Bazett’s correction method (QTcB)
or Fridericia’s correction method (QTcF)
18. In patients with uncontrolled hypertension, pheochromocytoma, carcinoid syndrome, or
thyrotoxicosis, the use of the following medications within 2 days before the first infusion
of study drug or planned use through the EOT Visit (see Section 14.7 for examples):
• Systemic directly and indirectly acting sympathomimetic agents (eg, pseudoephedrine,
phenylpropanolamine), vasopressive agents (eg, epinephrine, norepinephrine), or
dopaminergic agents (eg, dopamine, dobutamine). Use of a small amount of a
vasoconstrictor (eg, lidocaine containing epinephrine) during a minor surgical
procedure under local anesthesia (eg, incision and drainage) is allowed
19. Use of the following medications within 14 days before the first infusion of study drug or
planned use through the EOT Visit (see Section 14.7 for examples):
• Monoamine oxidase A and B (MAOA and MAOB) inhibitors (eg, phenelzine,
isocarboxazid)
• Serotonergic agents including antidepressants such as selective serotonin reuptake
inhibitors (SSRIs), tricyclic antidepressants, and serotonin 5-hydroxytryptamine
(5-HT1) receptor agonists (triptans), meperidine, or buspirone
20. High tyramine diet (see Section 14.1)
21. Treatment with any investigational medicinal product within 30 days before the first
infusion of study drug and previous assignment to treatment during this study.
22. Investigational device present, or removed < 30 days before the first infusion of study drug
or presence of device-related infection
23. Previous exposure to Tedizolid Phosphate treatment 4
24. Hypersensitivity to oxazolidinones or any component in the formulation
25. If aztreonam adjunctive therapy is required in patients with wound infections, history of
hypersensitivity to ceftazidime or any component of the aztreonam formulation
26. For patients with wound infections, history of hypersensitivity to metronidazole or any
component of the formulation, if metronidazole adjunctive therapy is required
27. Pregnant or breast-feeding women 5
28. Patients who the Investigator considers unlikely to adhere to the protocol, comply with
study drug administration, or complete the clinical study
29. Close affiliation with the investigational site; e.g., a close relative of the investigator,
dependent person (e.g., employee or student of the investigational site)
suppuration not surrounded by cellulitis/erysipelas), impetiginous lesions, superficial or
limited cellulitis/erysipelas, and minor wound infections (eg, stitch abscesses)
2. Infections associated with, or in close proximity to, a prosthetic device
3. Severe sepsis or septic shock
4. Known bacteremia at time of screening
5. 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 (i.e., necrotizing fasciitis)
• Infected human or animal bites. However, subjects with arthropod (e.g., insects, spiders,
‘bugs’) bites can be included since these are not considered animal bites in this study3
• Infections at vascular catheter sites or involving thrombophlebitis
• Incision surgical site infection with any of the following characteristics:
- Follows clean-contaminated surgery (urgent or emergency case that is otherwise
clean, elective opening of respiratory, gastrointestinal, biliary, or genitourinary tract
with minimal spillage [eg, appendectomy] not encountering infected urine or bile;
minor technique break)
- Follows contaminated surgery (nonpurulent inflammation; gross spillage from
gastrointestinal tract; entry into biliary or genitourinary tract in the presence of
infected bile or urine; major break in technique; chronic open wounds to be grafted
or covered)
- Follows dirty surgery (purulent inflammation [eg, abscess]; preoperative perforation
of respiratory, gastrointestinal, biliary, or genitourinary tract)
- Extends into the fascia or muscle layers, organs, or spaces
6. 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
7. Administration of Linezolid within 30 days before the first infusion of the study drug
8. Recent history of opportunistic infections where the underlying cause of these infections is
still active (eg, leukemia, transplant, acquired immunodeficiency syndrome [AIDS])
9. Receiving chronic systemic immunosuppressive therapy such as prednisone doses ≥ 20 mg
per day for ≥ 3 of the last 12 months OR therapies that in the Investigator’s judgment could
predispose to opportunistic infections
10. Chronic (daily for the previous 30 days) use of antipyretic medication (eg, acetaminophen,
paracetamol, nonsteroidal anti-inflammatory drugs [NSAIDs]). Low-dose aspirin (≤ 200
mg per day) for cardiovascular prophylaxis is allowed
11. Receiving treatment for active tuberculosis
12. Last known CD4 count < 200 cells/mm3
in patients with AIDS
13. Current or anticipated neutropenia with absolute neutrophil count (ANC) < 1000 cells/mm3
14. Severe renal disease defined as creatinine clearance (CrCl) < 30 mL/min estimated by the
Cockcroft-Gault formula OR requirement for peritoneal dialysis, plasmapheresis,
hemodialysis, venovenous dialysis, or other forms of renal filtration
15. ALT (alanine aminotransferase) or AST (aspartate aminotransferase) ≥ 5 upper limit of
normal OR moderate to severe hepatic disease with Child-Pugh score ≥7 defined by the
following:
• Presence of ascites upon examination
• Evidence of encephalopathy upon examination
• Total bilirubin ≥ 2 mg/dL
• Serum albumin ≤ 3.5 g/dL
• Prothrombin time (PT) ≥ 4 seconds longer than control, or international normalized ratio
(INR) ≥ 1.7
To calculate the Child-Pugh score, see section 7.1.2.1
16. Significant or life-threatening condition or organ or system condition or disease
(eg, endocarditis, meningitis, unstable CNS conditions, acidosis or history of lactic
acidosis) that would confound or interfere with the assessment of the ABSSSI
17. ECG finding of corrected QT interval > 500 msec using Bazett’s correction method (QTcB)
or Fridericia’s correction method (QTcF)
18. In patients with uncontrolled hypertension, pheochromocytoma, carcinoid syndrome, or
thyrotoxicosis, the use of the following medications within 2 days before the first infusion
of study drug or planned use through the EOT Visit (see Section 14.7 for examples):
• Systemic directly and indirectly acting sympathomimetic agents (eg, pseudoephedrine,
phenylpropanolamine), vasopressive agents (eg, epinephrine, norepinephrine), or
dopaminergic agents (eg, dopamine, dobutamine). Use of a small amount of a
vasoconstrictor (eg, lidocaine containing epinephrine) during a minor surgical
procedure under local anesthesia (eg, incision and drainage) is allowed
19. Use of the following medications within 14 days before the first infusion of study drug or
planned use through the EOT Visit (see Section 14.7 for examples):
• Monoamine oxidase A and B (MAOA and MAOB) inhibitors (eg, phenelzine,
isocarboxazid)
• Serotonergic agents including antidepressants such as selective serotonin reuptake
inhibitors (SSRIs), tricyclic antidepressants, and serotonin 5-hydroxytryptamine
(5-HT1) receptor agonists (triptans), meperidine, or buspirone
20. High tyramine diet (see Section 14.1)
21. Treatment with any investigational medicinal product within 30 days before the first
infusion of study drug and previous assignment to treatment during this study.
22. Investigational device present, or removed < 30 days before the first infusion of study drug
or presence of device-related infection
23. Previous exposure to Tedizolid Phosphate treatment 4
24. Hypersensitivity to oxazolidinones or any component in the formulation
25. If aztreonam adjunctive therapy is required in patients with wound infections, history of
hypersensitivity to ceftazidime or any component of the aztreonam formulation
26. For patients with wound infections, history of hypersensitivity to metronidazole or any
component of the formulation, if metronidazole adjunctive therapy is required
27. Pregnant or breast-feeding women 5
28. Patients who the Investigator considers unlikely to adhere to the protocol, comply with
study drug administration, or complete the clinical study
29. Close affiliation with the investigational site; e.g., a close relative of the investigator,
dependent person (e.g., employee or student of the investigational site)
The Estimated Number of Participants
-
Taiwan
45 participants
-
Global
708 participants
