TR-701 FA vs. Linezolid for the Treatment of Acute Bacter... | NCT01170221

NCT01170221

ID	Type	Description	Link
TR701-112	Other Identifier	TriusRX Unique ID

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TR-701 FA	Experimental	TR0-701 FA 200 mg tablets once a day for six days followed by 4 days of placebo	Drug: TR-701 FA
Linezolid	Active Comparator	Linezolid 600 mg tablets oral twice a day for 10 days	Drug: Linezolid

Name	Type	Description	Arm Group Labels	Other Names
TR-701 FA	Drug	Oral TR-701 FA 200 mg once daily for six days followed by four days of placebo.	TR-701 FA

Outcomes Module

Measure	Description	Time Frame
Early Clinical Response Rate	Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C	48-72 hours

Secondary Outcomes

Measure	Description	Time Frame
Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit.	Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C.	Day 11
Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit in the Clinically Evaluable-End of Therapy Analysis Sets

Eligibility Module

Contacts/Locations Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Trius investigator site 109		Dothan	Alabama	36301	United States
Trius Investigator site 130

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

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Tedizolid Phosphate	Oral Tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
FG001	Linezolid	Oral linezolid 600 mg twice daily for 10 days

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

Tedizolid Phosphate
TR-700 active moiety

All randomized participants

Arm/Group Information

ID	Title	Description
BG000	Tedizolid Phosphate	Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
BG001	Linezolid	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
	OG000264(-6.1 to 6.2) OG001266(-6.1 to 6.2)

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	The primary objective is to determine the noninferiority in the early clinical response rate of oral tedizolid phosphate compared with that of oral linezolid treatment at the 48-72 Hour Visit in the ITT Analysis Set in patients with ABSSSI.					Risk Difference (RD)	0.1				95	-6.1	6.2			Risk difference corresponds to tedizolid clinical response rate minus linezolid clinical response rate. The confidence interval was calculated using the Miettinen and Nurminen with stratification for the presence or absence of fever at baseline.		Non-Inferiority or Equivalence

Secondary

Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit.

Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C.

The ITT analysis set includes data from all randomized participants.

Posted

Number

participants

Day 11

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

Units	Counts
Participants	OG000

Secondary

Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit in the Clinically Evaluable-End of Therapy Analysis Sets

Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C

All randomized patients receiving minimal study therapy, completed 48-72 Hour and EOT assessments, no concomitant systemic antibiotic therapy through EOT, and had no confounding events or factors

Posted

Number

participants

EOT Day 11

ID	Title	Description
OG000	Tedizolid Phosphate	Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
OG001	Linezolid	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 most disease-specific signs and symptoms, absence/near resolution of systemic signs of infection, if present at baseline, no new signs, symptoms, or complications attributable to the ABSSSIs so no further antibiotic therapy was required for the treatment of the primary lesion.

The Intent to Treat analysis set included 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	Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
OG001	Linezolid	Oral linezolid 600 mg twice daily for 10 days

Units	Counts
Participants	OG000

Secondary

To Compare the Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit in the Clinically Evaluable-Post Treatment Evaluation Analysis Set

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

All randomized patients who received the minimal study therapy, completed EOT and PTE assessments, no concomitant systemic antibiotic therapy through PTE, and had 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	Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
OG001	Linezolid	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 was defined as improvement in overall clinical status.

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

Posted

Number

participants

48-72 Hour Visit

ID	Title	Description
OG000	Tedizolid Phosphate	Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
OG001	Linezolid	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 was 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	Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
OG001	Linezolid	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	Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
OG001	Linezolid	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	Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo			5	331	84	331
EG001	Linezolid	Oral linezolid 600 mg twice daily for 10 days			4	335	100	335

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac arrest	Cardiac disorders	MedDRA (13.1)	Systematic Assessment	EG0001 affected331 at risk EG0010 affected335 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (13.1)	Systematic Assessment	EG0001 affected331 at risk EG0010 affected335 at risk
Vomiting	Gastrointestinal disorders	MedDRA (13.1)	Systematic Assessment	EG0001 affected331 at risk EG0010 affected335 at risk
Abscess	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0001 affected331 at risk EG0010 affected335 at risk
Endophthalmitis	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0001 affected331 at risk EG0010 affected335 at risk
Pneumonia	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0001 affected331 at risk EG0010 affected335 at risk
Septic shock	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0001 affected331 at risk EG0010 affected335 at risk
Weight decreased	Investigations	MedDRA (13.1)	Systematic Assessment	EG0001 affected331 at risk EG0010 affected335 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (13.1)	Systematic Assessment	EG0001 affected331 at risk EG0010 affected335 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected331 at risk EG0011 affected335 at risk
VIIth nerve paralysis	Nervous system disorders	MedDRA (13.1)	Systematic Assessment	EG0001 affected331 at risk EG0010 affected335 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA (13.1)	Systematic Assessment	EG0000 affected331 at risk EG0011 affected335 at risk
Alcoholic psychosis	Psychiatric disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected331 at risk EG0011 affected335 at risk
Major depression	Psychiatric disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected331 at risk EG0011 affected335 at risk
Suicidal ideation	Psychiatric disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected331 at risk EG0011 affected335 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA (13.1)	Systematic Assessment	EG00028 affected331 at risk EG00145 affected335 at risk
Headache	Nervous system disorders	MedDRA (13.1)	Systematic Assessment	EG00021 affected331 at risk EG00117 affected335 at risk
Diarrhea	Gastrointestinal disorders	MedDRA (13.1)	Systematic Assessment	EG00015 affected331 at risk EG00118 affected335 at risk
Abscess	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG00014 affected331 at risk EG0018 affected335 at risk
Abscess limb	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG00012 affected331 at risk EG00110 affected335 at risk
Vomiting	Gastrointestinal disorders	MedDRA (13.1)	Systematic Assessment	EG0009 affected331 at risk EG00120 affected335 at risk
Cellulitis	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0008 affected331 at risk EG0018 affected335 at risk
Dizziness	Nervous system disorders	MedDRA (13.1)	Systematic Assessment	EG0008 affected331 at risk EG0017 affected335 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (13.1)	Systematic Assessment	EG0003 affected331 at risk EG0018 affected335 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (13.1)	Systematic Assessment	EG0002 affected331 at risk EG0017 affected335 at risk

ID	Term
C515040	tedizolid phosphate
D000069349	Linezolid

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

A two-sided 95% CI for the observed difference in the primary outcome measure (early clinical response at the 48-72 Hour Visit) between the tedizolid group and the linezolid group was calculated using the ITT analysis set. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10%.