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The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin and skin structure infections in adults.
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin and skin structure infections in adults. The primary focus is bacterial infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ceftaroline | Experimental | Intramuscular every 12 hours |
|
| linezolid plus optional aztreonam | Active Comparator | Intravenous every 12 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ceftaroline | Drug | 600 mg injected every 12 hours for at least 5 but not more than 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response at the Test of Cure (TOC) Visit in the Modified Intent-to-treat (MITT) Population | The coprimary efficacy outcome measures were the per-subject clinical cure rate at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) and (Modified-Intent-to-Treat) MITT Populations. Subjects were considered clinically cured at the Test of Cure (TOC) Visit if they had total resolution of all signs and symptoms of the baseline infection, or improvement of the infection to such an extent that no further antimicrobial therapy was necessary. | Test of Cure Visit (8 to 15 days after end of therapy) |
| Clinical Response at the Test-of-Cure (TOC) Visit in the Clinically Evaluable (CE) Population | The coprimary efficacy outcome measures were the per-subject clinical cure rate at the TOC Visit in the CE and MITT Populations. Subjects were considered clinically cured at the TOC Visit if they had total resolution of all signs and symptoms of the baseline infection, or improvement of the infection to such an extent that no further antimicrobial therapy was necessary. | Test of Cure Visit (8 to 15 Days after end of therapy) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Cure Rate at the TOC Visit in the cMITT Population | Evaluate per-subject the clinical response at the Test-of-Cure (TOC) Visit in the Clinical Modified Intent-to-treat (cMITT) Population. | TOC Visit (8 to 15 days after end of therapy) |
| Clinical Response at the End-of-Therapy (EOT) Visit in the MITT, cMITT and CE Populations. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor Cerexa | Forest Laboratories | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Buena Park | California | 96020 | United States | ||
| Investigational Site |
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Twelve (12) study centers in the U.S. participated in this open label trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ceftaroline | Intramuscular every 12 hours |
| FG001 | Linezolid | Intravenous Linezolid every 12 hours (with or without Aztreonam) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| linezolid | Drug | 600 mg parenteral infused over 60 minutes for a minimum of 5 days and a maximum of 14 days |
|
|
| Aztreonam | Drug | 1000 mg infused over 60 minutes every 24 hours may be started with linezolid or added later (up to 72 hours after the first dose of linezolid) for subjects with a gram-negative infection indicated. |
|
Evaluate per-subject the clinical response at the End-of-therapy (EOT) Visit in the MITT, cMITT and CE populations. |
| End-of-therapy (EOT) visit |
| The Microbiological Response at the TOC Visit in the mMITT and ME Populations. | Evaluate per-subject the microbiological response at the TOC Visit in the Microbiological Modified Intent-to-treat (mMITT) and Microbiologically Evaluable (ME) populations. | TOC Visit (8 to 15 days after end of therapy) |
| Clinical and Microbiological Response by Pathogen at the TOC Visit in the mMITT and ME Populations | Evaluate the clinical and microbiological response by pathogen at the TOC Visit in the mMITT and ME populations. | TOC Visit (8 to 15 days after end of therapy) |
| Clinical Relapse at the Late Follow-up Visit | Evaluate Clinical relapse rate at Late Follow-up (LFU) (21 to 45 days after the final dose of study drug)in those subjects clinically cured at the TOC visit. | Late Follow-up (LFU) Visit (21 to 35 days after end of therapy) |
| The Microbiological Reinfection or Recurrence at the Late Follow-up (LFU) Visit | Evaluate per-subject reinfection or recurrence rate at the LFU Visit in those subjects who had a favorable microbiological outcome (eradication or presumed eradication) at the TOC Visit. | LFU Visit (21 to 35 days after end of therapy) |
| The Safety of Ceftaroline Fosamil | Evaluate safety of Ceftaroline fosamil IM in adults with complicated skin and skin structure infection (cSSSI) | First dose of study drug through LFU Visit or 30 days after the last dose of study drug |
| Long Beach |
| California |
| 90813 |
| United States |
| Investigational Site | Los Angeles | California | 90015 | United States |
| Investigational Site | Rolling Hills Estate | California | 90274 | United States |
| Investigational Site | San Diego | California | 92114 | United States |
| Investigational Site | Atlantis | Florida | 33462 | United States |
| Investigational Site | Columbus | Georgia | 31904 | United States |
| Investigational Site | Savannah | Georgia | 31405 | United States |
| Investigational Site | Minneapolis | Minnesota | 55422 | United States |
| Investigational Site | Butte | Montana | 59701 | United States |
| Investigational Site | Somers Point | New Jersey | 08244 | United States |
| Investigational Site | Columbus | Ohio | 43215 | United States |
| Investigational Site | Toledo | Ohio | 43608 | United States |
| MITT and Safety Population |
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| Clinically Evaluable Population |
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| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ceftaroline | Intramuscular every 12 hours |
| BG001 | Linezolid | Intravenous Linezolid every 12 hours (with or without Aztreonam) |
| BG002 | Total | Total of all reporting groups |
| 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 |
| ||||||||||||||||
| Region of Enrollment | Number | 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 at the Test of Cure (TOC) Visit in the Modified Intent-to-treat (MITT) Population | The coprimary efficacy outcome measures were the per-subject clinical cure rate at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) and (Modified-Intent-to-Treat) MITT Populations. Subjects were considered clinically cured at the Test of Cure (TOC) Visit if they had total resolution of all signs and symptoms of the baseline infection, or improvement of the infection to such an extent that no further antimicrobial therapy was necessary. | Modified-Intent-to-Treat (MITT) Population - Any randomized subjects that received any amount of study drug | Posted | Number | 95% Confidence Interval | percentage of participants | Test of Cure Visit (8 to 15 days after end of therapy) |
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| Primary | Clinical Response at the Test-of-Cure (TOC) Visit in the Clinically Evaluable (CE) Population | The coprimary efficacy outcome measures were the per-subject clinical cure rate at the TOC Visit in the CE and MITT Populations. Subjects were considered clinically cured at the TOC Visit if they had total resolution of all signs and symptoms of the baseline infection, or improvement of the infection to such an extent that no further antimicrobial therapy was necessary. | The Clinically Evaluable (CE) Population included all subjects who satisfied key minimum protocol criteria | Posted | Number | 95% Confidence Interval | percentage of participants | Test of Cure Visit (8 to 15 Days after end of therapy) |
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| Secondary | Clinical Cure Rate at the TOC Visit in the cMITT Population | Evaluate per-subject the clinical response at the Test-of-Cure (TOC) Visit in the Clinical Modified Intent-to-treat (cMITT) Population. | Not Posted | TOC Visit (8 to 15 days after end of therapy) | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Clinical Response at the End-of-Therapy (EOT) Visit in the MITT, cMITT and CE Populations. | Evaluate per-subject the clinical response at the End-of-therapy (EOT) Visit in the MITT, cMITT and CE populations. | Not Posted | End-of-therapy (EOT) visit | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | The Microbiological Response at the TOC Visit in the mMITT and ME Populations. | Evaluate per-subject the microbiological response at the TOC Visit in the Microbiological Modified Intent-to-treat (mMITT) and Microbiologically Evaluable (ME) populations. | Not Posted | TOC Visit (8 to 15 days after end of therapy) | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Clinical and Microbiological Response by Pathogen at the TOC Visit in the mMITT and ME Populations | Evaluate the clinical and microbiological response by pathogen at the TOC Visit in the mMITT and ME populations. | Not Posted | TOC Visit (8 to 15 days after end of therapy) | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Clinical Relapse at the Late Follow-up Visit | Evaluate Clinical relapse rate at Late Follow-up (LFU) (21 to 45 days after the final dose of study drug)in those subjects clinically cured at the TOC visit. | Not Posted | Late Follow-up (LFU) Visit (21 to 35 days after end of therapy) | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | The Microbiological Reinfection or Recurrence at the Late Follow-up (LFU) Visit | Evaluate per-subject reinfection or recurrence rate at the LFU Visit in those subjects who had a favorable microbiological outcome (eradication or presumed eradication) at the TOC Visit. | Not Posted | LFU Visit (21 to 35 days after end of therapy) | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | The Safety of Ceftaroline Fosamil | Evaluate safety of Ceftaroline fosamil IM in adults with complicated skin and skin structure infection (cSSSI) | Not Posted | First dose of study drug through LFU Visit or 30 days after the last dose of study drug | Participants |
Date of First Dose of study drug to the TOC visit (AEs) or LFU visit (SAEs).
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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 | Ceftaroline | Intramuscular every 12 hours | 4 | 98 | 35 | 98 | ||
| EG001 | Linezolid | Intravenous Linezolid every 12 hours (with or without Aztreonam) | 0 | 45 | 15 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Skin and subcutaneous tissue disorders | MEDRA 11.1 | Systematic Assessment |
| |
| Necrotizing fasciitis | Skin and subcutaneous tissue disorders | MEDRA 11.1 | Systematic Assessment |
| |
| Postoperative wound infection | Skin and subcutaneous tissue disorders | MEDRA 11.1 | Systematic Assessment |
| |
| Skin infection | Skin and subcutaneous tissue disorders | MEDRA 11.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MEDRA 11.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MEDRA 11.1 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MEDRA 11.1 | Systematic Assessment |
| |
| Injection site irritation | General disorders | MEDRA 11.1 | Systematic Assessment | Administration site conditions |
|
| Somnolence | Nervous system disorders | MEDRA 11.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MEDRA 11.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MEDRA 11.1 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Clinical Sciences | Cerexa, Inc. | 510-285-9200 | clinicaltrials@cerexa.com |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D002481 | Cellulitis |
| D000038 | Abscess |
| D014946 | Wound Infection |
| D016908 | Gram-Positive Bacterial Infections |
| D016905 | Gram-Negative Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000097583 | Ceftaroline |
| D007267 | Injections |
| D000069349 | Linezolid |
| D001398 | Aztreonam |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D000081 | Acetamides |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D008997 | Monobactams |
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| Male |
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