TR-701 FA vs Linezolid for the Treatment of Acute Bacteri... | NCT01421511

ID	Type	Description	Link
TR701-113	Other Identifier	TriusRX Unique ID

TR-701 FA vs Linezolid for the Treatment of Acute Bacteri... | NCT01421511 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TR-701 FA	Experimental	• TR-701 FA IV followed by TR-701 FA tablets	Drug: TR-701 FA
Linezolid	Active Comparator	• Linezolid IV followed by Linezolid Tablets	Drug: Linezolid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TR-701 FA	Drug	TR-701 FA 200 mg once daily in 250 mL sterile saline for injection as a 60 minute IV infusion TR-701 FA Tablets, 200 mg, orally once daily	TR-701 FA

Outcomes Module

Measure	Description	Time Frame
The Early Clinical Response Rate	Responder: No increase in lesion surface area from baseline.	48-72 hours

Secondary Outcomes

Measure	Description	Time Frame
Clinical Response at the End of Therapy Visit	Responder: No increase in lesion surface area from baseline.	Day 11
Clinical Response at the End of Therapy Visit in the Clinically Evaluable at End of Therapy Analysis Set

Contacts/Locations Module

Name	Affiliation	Role
Philippe G Prokocimer, MD	Trius Therapeutics	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Trius investigator site 159		Dothan	Alabama	36305	United States
Trius investigator site 103

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28264845	Derived	Sandison T, De Anda C, Fang E, Das AF, Prokocimer P. Clinical Response of Tedizolid versus Linezolid in Acute Bacterial Skin and Skin Structure Infections by Severity Measure Using a Pooled Analysis from Two Phase 3 Double-Blind Trials. Antimicrob Agents Chemother. 2017 Apr 24;61(5):e02687-16. doi: 10.1128/AAC.02687-16. Print 2017 May.
28003218

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Tedizolid Phosphate	IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
FG001	Linezolid	IV to oral linezolid 600 mg twice daily for 10 days.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Lost to Follow-up		FG00011 subjects FG00114 subjects
Randomized but didn't receive study drug		FG0001 subjects FG0017 subjects
Physician Decision		FG0000 subjects FG0011 subjects
Withdrawal by Subject		FG0006 subjects FG0015 subjects
Death		FG0001 subjects FG0011 subjects

Arm/Group Information

ID	Title	Description
BG000	Tedizolid Phosphate	IV to oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo.
BG001	Linezolid	IV to oral linezolid 600 mg twice daily for 10 days.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00045.6± 15.79 BG00145.6± 15.57 BG00245.6± 15.67

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000107 BG001120 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

The Early Clinical Response Rate

Responder: No increase in lesion surface area from baseline.

The Intent to Treat analysis set includes data from all randomized participants.

Posted

Number

participants

48-72 hours

ID	Title	Description
OG000	Tedizolid Phosphate	IV to oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo.
OG001	Linezolid	IV to oral linezolid 600 mg twice daily for 10 days.

Units	Counts
Participants	OG000332 OG001334

Title

Denominators

Categories

Title	Measurements
	OG000283 OG001276

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Risk Difference (RD)	2.6			2-Sided	95	-3.0	8.2			Risk difference corresponds to the tedizolid responder rate minus the linezolid responder rate.		Non-Inferiority or Equivalence	A two-sided 95% CI was calculated for the observed differences in the early clinical response rates at 48 to 72 Hours after the first infusion of study drug using the method of Miettinen and Nurminen without stratification. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10%.

Secondary

Clinical Response at the End of Therapy Visit

Responder: No increase in lesion surface area from baseline.

The Intent to Treat analysis set includes data from all randomized participants.

Posted

Number

participants

Day 11

ID	Title	Description
OG000	Tedizolid Phosphate	IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
OG001	Linezolid	IV to oral linezolid 600 mg twice daily for 10 days.

Units	Counts
Participants	OG000

Secondary

Clinical Response at the End of Therapy Visit in the Clinically Evaluable at End of Therapy Analysis Set

Responder: No increase in lesion surface area from baseline.

All randomized participants receiving minimal study therapy, completed EOT assessment, no concomitant systemic antibiotic therapy and no confounding events or factors.

Posted

Number

participants

End of Therapy Day 11

ID	Title	Description
OG000	Tedizolid Phosphate	IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
OG001	Linezolid	IV to oral linezolid 600 mg twice daily for 10 days.

Units	Counts
Participants	OG000

Secondary

Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit

Clinical success defined as resolution/near resolution of disease specific signs and symptoms, absence/near resolution of baseline systemic signs of infection, and no further antibiotic therapy required for treatment of primary ABSSSI lesion.

The Intent to Treat analysis set includes data from all randomized participants.

Posted

Number

participants

Post-Treatment Evaluation (7-14 days after the End of Therapy)

ID	Title	Description
OG000	Tedizolid Phosphate	IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
OG001	Linezolid	IV to oral linezolid 600 mg twice daily for 10 days.

Units	Counts
Participants	OG000

Secondary

Investigator's Assessment of Clinical Success of the Post Therapy Evaluation Visit in Clinically Evaluable-Post Treatment Evaluation Analysis Set.

Clinical success defined as resolution/near resolution of disease specific signs and symptoms, absence/near resolution of baseline systemic signs of infection, no new signs, symptoms or complications attributable to the ABSSSI and no further antibiotic therapy required for treatment of primary ABSSSI lesion.

All randomized participants receiving minimal study therapy, completed EOT and PTE Investigator's assessments, no concomitant systemic antibiotic therapy through PTE, and no confounding events or factors.

Posted

Number

participants

Post-Treatment Evaluation (7-14 days after the End of Therapy)

ID	Title	Description
OG000	Tedizolid Phosphate	IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
OG001	Linezolid	IV to oral linezolid 600 mg twice daily for 10 days.

Units	Counts
Participants

Secondary

Investigator's Assessment of Clinical Response at the 48-72 Hour Visit

Clinical improvement defined as improvement in overall clinical status.

The Intent to Treat analysis set includes data from all randomized participants.

Posted

Number

participants

48-72 Hours

ID	Title	Description
OG000	Tedizolid Phosphate	IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
OG001	Linezolid	IV to oral linezolid 600 mg twice daily for 10 days.

Units	Counts
Participants	OG000

Secondary

Investigator's Assessment of Clinical Response at the Day-7 Visit

Clinical improvement defined as improvement in overall clinical status.

The Intent to Treat analysis set includes data from all randomized participants.

Posted

Number

participants

Day 7

ID	Title	Description
OG000	Tedizolid Phosphate	IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
OG001	Linezolid	IV to oral linezolid 600 mg twice daily for 10 days.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Patient-reported Pain, by Study Visit

0=no pain, 10=worst pain Only 1 visit per participant for Day 4-6, only 1 visit for Day 7-9, and only 1 visit for Day 10-13.

The Intent to Treat analysis set includes data from all randomized participants.

Posted

Mean

Standard Deviation

units on a scale

Multiple

ID	Title	Description
OG000	Tedizolid Phosphate	IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
OG001	Linezolid	IV to oral linezolid 600 mg twice daily for 10 days.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Tedizolid Phosphate	IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.			7	331	84	331
EG001	Linezolid	IV to oral linezolid 600 mg twice daily for 10 days.			9	327	90	327

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute coronary syndrome	Cardiac disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected331 at risk EG0011 affected327 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected331 at risk EG0011 affected327 at risk
Myocardial infarction	Cardiac disorders	MedDRA (13.1)	Systematic Assessment	EG0001 affected331 at risk EG0010 affected327 at risk
Anaphylactic reaction	Immune system disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected331 at risk EG0011 affected327 at risk
Cellutitis	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0000 affected331 at risk EG0012 affected327 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0001 affected331 at risk EG0010 affected327 at risk
Meningitis tuberculous	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0000 affected331 at risk EG0011 affected327 at risk
Pneumonia	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0001 affected331 at risk EG0010 affected327 at risk
Septic shock	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0001 affected331 at risk EG0010 affected327 at risk
Staphyloccal bacteraemia	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0001 affected331 at risk EG0010 affected327 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0000 affected331 at risk EG0011 affected327 at risk
Blood glucose increased	Investigations	MedDRA (13.1)	Systematic Assessment	EG0000 affected331 at risk EG0011 affected327 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (13.1)	Systematic Assessment	EG0001 affected331 at risk EG0010 affected327 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (13.1)	Systematic Assessment	EG0001 affected331 at risk EG0010 affected327 at risk
Hypertension	Vascular disorders	MedDRA (13.1)	Systematic Assessment	EG0001 affected331 at risk EG0010 affected327 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected331 at risk EG0011 affected327 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA (13.1)	Systematic Assessment	EG00011 affected331 at risk EG00117 affected327 at risk
Nausea	Gastrointestinal disorders	MedDRA (13.1)	Systematic Assessment	EG00026 affected331 at risk EG00136 affected327 at risk
Vomiting	Gastrointestinal disorders	MedDRA (13.1)	Systematic Assessment	EG00010 affected331 at risk EG00117 affected327 at risk
Fatigue	General disorders	MedDRA (13.1)	Systematic Assessment	EG0008 affected331 at risk EG0017 affected327 at risk
Abscess	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG00014 affected331 at risk EG00110 affected327 at risk
Cellulitis	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0009 affected331 at risk EG0016 affected327 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0002 affected331 at risk EG0017 affected327 at risk
Dizziness	Nervous system disorders	MedDRA (13.1)	Systematic Assessment	EG0004 affected331 at risk EG0017 affected327 at risk
Headache	Nervous system disorders	MedDRA (13.1)	Systematic Assessment	EG00020 affected331 at risk EG00122 affected327 at risk

Ancestor Terms

ID	Term
D000081	Acetamides
D000577	Amides
D009930	Organic Chemicals
D000085	Acetates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D023303	Oxazolidinones
D010080	Oxazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001					Hierarchical testing procedure of Westfall and Krishen used to control for inflation of the overall type I error rate. If NI is declared for the primary, NI will be tested for the secondary outcomes in this order: Secondary Outcomes Measures 2 to 5.	Risk Difference (RD)	-1.0			2-Sided	95	-6.1	4.1			Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.		Non-Inferiority or Equivalence	A two-sided 95% CI was calculated for the observed differences in the programmatic clinical response at the EOT visit using the method of Miettinen and Nurminen without stratification. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Risk Difference (RD)	-4.1			2-Sided	95	-8.8	0.3			Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.		Non-Inferiority or Equivalence	A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the Investigator's assessment of clinical response at the EOT Visit using the method of Miettinen and Nurminen without stratification. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Risk Difference (RD)	0.3			2-Sided	95	-4.8	5.3			Risk difference corresponds to the tedizolid clinical success rate minus the linezolid clinical success rate.		Non-Inferiority or Equivalence	A two-sided 95% CI was calculated for the observed differences in the clinical success rate based on the Investigator's assessment of clinical response at the PTE Visit using the method of Miettinen and Nurminen without stratification. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Risk Difference (RD)	-3.7			2-Sided	95	-7.7	0.2			Risk difference corresponds to the tedizolid clinical success rate minus the linezolid clinical success rate.		Non-Inferiority or Equivalence	A two-sided 95% CI was calculated for the observed differences in the clinical success rate based on the Investigator's assessment of clinical response at the PTE Visit using the method of Miettinen and Nurminen without stratification. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the Investigator's assessment of clinical response at the 48-72 Hour Visit using the method of Miettinen and Nurminen without stratification.					Risk Difference (RD)	1.2			2-Sided	95	-3.3	5.6			Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.		Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the Investigator's assessment of clinical response at the Day 7 Visit using the method of Miettinen and Nurminen without stratification.					Risk Difference (RD)	0.9			2-Sided	95	-3.2	4.9			Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.		Superiority or Other

Title

Denominators

Categories

Day 2

Title	Measurements
	OG000-1.7± 2.05 OG001-2.1± 2.29

Day 4-6

Title	Measurements
	OG000-3.1± 2.67 OG001-3.3± 2.56

Day 7-9

Title	Measurements
	OG000-4.9± 2.89 OG001-4.9± 2.96

Day 10-13

Title	Measurements
	OG000-5.4± 2.80 OG001-5.6± 2.84