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| ID | Type | Description | Link |
|---|---|---|---|
| TR701-126 | Other Identifier | TriusRX Unique ID |
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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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Characterization of the safety profile of TR-701 Free Acid (FA) in patients with major cutaneous abscess or cellulitis/erysipelas.
This is an open-label, multicenter study of oral TR-701 FA 200 mg once daily for 6 days for the treatment of major cutaneous abscess or cellulitis/erysipelas in patients 18 years of age or older. This study is designed to further characterize the safety profile and gather additional lesion measurement data of TR-701 FA in patients with major cutaneous abscess or cellulitis/erysipelas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TR-701 FA | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TR701 FA | Drug | 1 tablet 200 mg once daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Safety will be assessed through summaries of the incidence of AEs and SAEs as well as through summaries of vital signs, physical examinations, ECG findings, and laboratory assessments (hematology, serum chemistry, and urinalysis). | 24-31 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Prokocimer, MD | Trius Therapeutics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trius Investigator Site #118 | Anaheim | California | 92804 | United States | ||
| Trius Investigator Site #129 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27530088 | Result | Powers JH 3rd, Das AF, De Anda C, Prokocimer P. Clinician-reported lesion measurements in skin infection trials: Definitions, reliability, and association with patient-reported pain. Contemp Clin Trials. 2016 Sep;50:265-72. doi: 10.1016/j.cct.2016.08.010. Epub 2016 Aug 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | TR-701 FA | TR701 FA: 1 tablet 200 mg once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Buena Park |
| California |
| 90620 |
| United States |
| Trius Investigator Site 103 | Chula Vista | California | 91911 | United States |
| Trius Investigator Site 105 | La Mesa | California | 91942 | United States |
| Trius Investigator Site #106 | Long Beach | California | 90813 | United States |
| Trius Investigator Site 104 | Oceanside | California | 92056 | United States |
| Trius Investigator Site 101 | Columbus | Georgia | 31904 | United States |
| Trius Investigator Site 102 | Savannah | Georgia | 31406 | United States |
| Trius Investigator Site 128 | Las Vegas | Nevada | 89109 | United States |
| Trius Investigator Site 115 | Somers Point | New Jersey | 08244 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TR-701 FA | TR701 FA: 1 tablet 200 mg once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Safety will be assessed through summaries of the incidence of AEs and SAEs as well as through summaries of vital signs, physical examinations, ECG findings, and laboratory assessments (hematology, serum chemistry, and urinalysis). | Patients receiving any amount of study drug | Posted | Number | participants | 24-31 days |
|
|
|
From the Informed Consent Form signature through the late follow-up visit, up to 32 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 FA | TR701 FA: 1 tablet 200 mg once daily | 2 | 200 | 58 | 200 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| thrombophlebitis septic | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| diarrhea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| cellulitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| abscess | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| chills | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| constipation | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| somnolence | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
Trius 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 study agreement between Trius and Investigators. Trius written approval is required for publication of any data subsets. Final authorship will be determined in accordance with the International Conference of Medical Journal Editors definition of authorship.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carisa De Anda, Phd, Vice President Clinical Research | Cubist Pharmaceuticals | 8583522639 | carisa.deanda@cubist.com |
| ID | Term |
|---|---|
| D002481 | Cellulitis |
| D004886 | Erysipelas |
| ID | Term |
|---|---|
| D012874 | Skin Diseases, Infectious |
| D007239 | Infections |
| D013492 | Suppuration |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D017192 | Skin Diseases, Bacterial |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C546016 | tedizolid |
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