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| ID | Type | Description | Link |
|---|---|---|---|
| TR701-104 | Other Identifier | TriusRX Unique ID |
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The purpose of the study is to determine the oral dosage of TR-701 to be used in Phase III studies in patients with complicated skin and skin structure infections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TR-701 200 mg | Experimental |
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| TR-701 300 mg | Experimental |
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| TR-701 400 mg | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TR-701 200 mg | Drug | oral TR-701 200 mg for 5 to 7 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response Rate at Test of Cure in the Clinically Evaluable Analysis Set | Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required. | 7 to 14 days after the last dose of study drug |
| Clinical Response Rate at Test of Cure in the Clinical Modified Intent to Treat Analysis Set | Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required. | 7-14 days after last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate at End of Therapy | Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required. | last day of study treatment |
| Microbiological Response Rate at Test of Cure in the Microbiologically Evaluable Analysis Set |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Prokocimer, MD | Trius | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trius Study Site #011 | Dothan | Alabama | 36301 | United States | ||
| Trius Study site #001 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22687509 | Result | Prokocimer P, Bien P, Deanda C, Pillar CM, Bartizal K. In vitro activity and microbiological efficacy of tedizolid (TR-700) against Gram-positive clinical isolates from a phase 2 study of oral tedizolid phosphate (TR-701) in patients with complicated skin and skin structure infections. Antimicrob Agents Chemother. 2012 Sep;56(9):4608-13. doi: 10.1128/AAC.00458-12. Epub 2012 Jun 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | TR-701 200 mg | Oral TR-701 200 mg once daily for 5 to 7 days |
| FG001 | TR-701 300 mg | Oral TR-701 300 mg once daily for 5 to 7 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| TR-701 300 mg |
| Drug |
oral TR-701 300 mg for 5 to 7 days |
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| TR-701 400 mg | Drug | TR-701 400 mg for 5 to 7 days |
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Satisfactory microbiological outcomes are eradication and presumed eradication |
| 7-14 days after last dose of study drug |
| Clinical Outcome at the Late Follow-up Visit in the Clinical Modified Intent to Treat Analysis Set | Persistent clinical cure was defined as continuing favorable response. | 21 to 28 days after the last study drug |
| To Evaluate the Safety Profile of Tedizolid Phosphate | Multiple |
| Population PK | Multiple |
| Microbiological Recurrence at Late Follow-up in Clinical Modified Intent to Treat Analysis Set | 21-28 days after last study drug |
| Chula Vista |
| California |
| 91911 |
| United States |
| Trius Study Site #009 | Long Beach | California | 92708 | United States |
| Trius Study site #002 | Oceanside | California | 92056 | United States |
| Trius Study site #010 | Pasadena | California | 91105 | United States |
| Trius Study site 007 | San Francisco | California | 94143 | United States |
| Trius Study site 003 | San Jose | California | 95124 | United States |
| Trius Study site 004 | Columbus | Georgia | 31904 | United States |
| Trius Study site #006 | Ludowici | Georgia | 31316 | United States |
| Trius Study site #005 | Savannah | Georgia | 31406 | United States |
| Trius Study site #012 | Springfield | Illinois | 62701 | United States |
| Trius study sie #008 | Detroit | Michigan | 48202 | United States |
| FG002 | TR-701 400 mg | Oral TR-701 400 mg once daily for 5 to 7 days |
| COMPLETED |
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| NOT COMPLETED |
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All randomized participants who received study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | TR-701 200 mg | Oral TR-701 200 mg once daily for 5 to 7 days |
| BG001 | TR-701 300 mg | Oral TR-701 300 mg once daily for 5 to 7 days |
| BG002 | TR-701 400 mg | Oral TR-701 400 mg once daily for 5 to 7 days |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Clinical Response Rate at Test of Cure in the Clinically Evaluable Analysis Set | Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required. | The Clinically Evaluable analysis set includes data from all participants who had a diagnosis of cSSSI, received minimal study therapy, completed an assessment, and had no confounding events or factors. | Posted | Number | 95% Confidence Interval | Percentage of participants | 7 to 14 days after the last dose of study drug |
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| Primary | Clinical Response Rate at Test of Cure in the Clinical Modified Intent to Treat Analysis Set | Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required. | The clinically modified intent to treat analysis set includes data from all participants who received study drug and had a diagnosis of complicated skin and skin structure infection. | Posted | Number | 95% Confidence Interval | Percentage of participants | 7-14 days after last dose of study drug |
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| Secondary | Response Rate at End of Therapy | Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required. | The clinical modified intent to treat analysis set includes data from all participants who received study drug and had a diagnosis of complicated skin and skin structure infection | Posted | Number | 95% Confidence Interval | Percentage of participants | last day of study treatment |
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| Secondary | Microbiological Response Rate at Test of Cure in the Microbiologically Evaluable Analysis Set | Satisfactory microbiological outcomes are eradication and presumed eradication | The microbiologically evaluable analysis set includes all participants who received study drug, had a diagnosis of complicated skin and skin structure infection, completed an assessment, had no confounding events or factors, and had a baseline Gram-positive bacterial pathogen. | Posted | Number | 95% Confidence Interval | Percentage of participants | 7-14 days after last dose of study drug |
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| Secondary | Clinical Outcome at the Late Follow-up Visit in the Clinical Modified Intent to Treat Analysis Set | Persistent clinical cure was defined as continuing favorable response. | The clinical modified intent to treat analysis set includes data from all participants who received study drug and had a diagnosis of complicated skin and skin structure infection. Microbiological samples not available from all participants. | Posted | Number | Percentage of Participants | 21 to 28 days after the last study drug |
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| Secondary | To Evaluate the Safety Profile of Tedizolid Phosphate | Not Posted | Multiple | Participants | ||||||||||||||||||||||||||||||||||||||
| Secondary | Population PK | Not Posted | Multiple | Participants | ||||||||||||||||||||||||||||||||||||||
| Secondary | Microbiological Recurrence at Late Follow-up in Clinical Modified Intent to Treat Analysis Set | The clinical modified intent to treat analysis set includes data from all participants who received study drug and had a diagnosis of complicated skin and skin structure infection. Microbiological samples not available from all participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | 21-28 days after last study drug |
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Adverse events were to be collected after informed consent through last visit (up to 36 days).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TR-701 200 mg | Oral TR-701 200 mg once daily for 5 to 7 days | 2 | 63 | 40 | 63 | ||
| EG001 | TR-701 300 mg | Oral TR-701 300 mg once daily for 5 to 7 days | 1 | 63 | 44 | 63 | ||
| EG002 | TR-701 400 mg | Oral TR-701 400 mg once daily for 5 to 7 days | 2 | 62 | 43 | 62 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
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| Abcess | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Abscess | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Skin infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA 11.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
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Sponsor intends to pursue publication of the results of the study in cooperation with a lead Investigator, subject to the terms and conditions of the clinical trial agreement between Sponsor and Investigators. Sponsor approval is required for publication of any data subsets. Final authorship will be determined by contributions to study design, enrollment, data analysis, and/or interpretation of the results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Philippe Prokocimer, MD | Cubist Pharmaceuticals, Inc. | 858-452-0370 | 241 | philippe.prokocimer@cubist.com |
| ID | Term |
|---|---|
| D012874 | Skin Diseases, Infectious |
| D017192 | Skin Diseases, Bacterial |
| D007239 | Infections |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C515040 | tedizolid phosphate |
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| Male |
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