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The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.
Additional purpose of this study is to compare ceftaroline effectivity versus Vancomycin plus Aztreonam in the treatment of complicated skin infections in adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ceftaroline fosamil for Injection | Experimental | Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours. |
|
| IV Vancomycin plus IV Aztreonam | Active Comparator | Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ceftaroline | Drug | 600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Cure Rate at Test of Cure (TOC) (MITT Population) | Cure: Total resolution of all signs and symptoms of the baseline infection, or improvement of the infection such that no further antimicrobial therapy was necessary. Failure: Requirement of alternative antimicrobial therapy for primary infection of complicated skin and skin structure infection (cSSSI) due to inadequate response, recurrence, new infection at the same site; treatment-limiting adverse event (AE); requirement for surgery due to failure of study drug; diagnosis of osteomyelitis after Study Day 8; or death caused by cSSSI. Indeterminate: Inability to determine an outcome | 8-15 days after last dose of study drug administration |
| The Primary Efficacy Outcome Measure Was the Per-subject Clinical Cure Rate at the TOC Visit in the Clinically Evaluable (CE) Populations. | 8-15 days after last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| To Evaluate the Microbiological Success Rate at the TOC Visit | 8-15 days after the last dose of study drug | |
| To Evaluate the Clinical Response at the End of Therapy (EOT) Visit | last day of study drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Wilcox, MD | Old Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Buena Park | California | 90620 | United States | ||
| Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34922058 | Derived | Dryden M, Kantecki M, Yan JL, Stone GG, Leister-Tebbe H, Wilcox M. Treatment outcomes of secondary bacteraemia in patients treated with ceftaroline fosamil: pooled results from six phase III clinical trials. J Glob Antimicrob Resist. 2022 Mar;28:108-114. doi: 10.1016/j.jgar.2021.10.027. Epub 2021 Dec 16. | |
| 34741280 | Derived |
Not provided
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Patients were screened for up to 24 hours
Patients were recruited worldwide from March 2007 to December 2007
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| ID | Title | Description |
|---|---|---|
| FG000 | Ceftaroline for Injection | Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours. |
| FG001 | IV Vancomycin Plus IV Aztreonam |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| vancomycin plus aztreonam | Drug | vancomycin at 1 g parenteral infused over 60 minutes followed by aztreonam 1 g infused over 60 minutes, every 12 hours, for 5 to 14 days. |
|
|
| Placebo | Drug | Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours. |
|
| To Evaluate the Clinical and Microbiological Response by Pathogen at the TOC Visit | 8-15 days after last dose of study drug |
| To Evaluate Clinical Relapse at the Late Follow Up (LFU) Visit | 21 to 35 days after the last dose of study drug |
| To Evaluate Microbiological Reinfection or Recurrence at the LFU Visit | 21-35 days after last dose of study drug |
| To Evaluate Safety | first study drug dose through TOC |
| Hawaiian Gardens |
| California |
| 90716 |
| United States |
| Investigational Site | Los Angeles | California | 90033 | United States |
| Investigational Site | Pasadena | California | 91105 | United States |
| Investigational Site | San Diego | California | 92114 | United States |
| Investigational Site | San Jose | California | 95124 | United States |
| Investigational Site | Atlantis | Florida | 33462 | United States |
| Investigational Site | Columbus | Georgia | 31904 | United States |
| Investigational Site | Marietta | Georgia | 30060 | United States |
| Investigational Site | Springfield | Illinois | 62701 | United States |
| Investigational Site | Baltimore | Maryland | 21201 | 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 | Toledo | Ohio | 43608 | United States |
| Investigational Site | Tacoma | Washington | 98405 | United States |
| Investigational Site | Milwaukee | Wisconsin | 53215 | United States |
| Investigational Site | Buenos Aires | Argentina |
| Investigational Site | Córdoba | Argentina |
| Investigational Site | Santa Fe | Argentina |
| Investigational Site | Braunau am Inn | Austria |
| Investigational Site | Graz | 8036 | Austria |
| Investigational Site | Sankt Pölten | 3100 | Austria |
| Investigational Site | Sao Paula | Brazil |
| Investigational Site | Temuco | Chile |
| Investigational Site | Valdivia | Chile |
| Investigational Site | Cottbus | 03048 | Germany |
| Investigational Site | Dortmund | 44145 | Germany |
| Investigational Site | Homburg/Saar | D-66421 | Germany |
| Investigational Site | Mainz | D-55101 | Germany |
| Investigational Site | Wiesbaden | 65191 | Germany |
| Investigational Site | Riga | LV-1001 | Latvia |
| Investigational Site | Guadalajara | Jalisco | 44280 | Mexico |
| Investigational Site | Seattle Zapopan | Jalisco | 45170 | Mexico |
| Investigational Site | Bielsko-Biala | 43-316 | Poland |
| Investigational Site | Krakow | 31-501 | Poland |
| Investigational Site | Krakow | 31-820 | Poland |
| Investigational Site | Lodz | 91-425 | Poland |
| Investigational Site | Lublin | 20-954 | Poland |
| Investigational Site | Poznan | 61-848 | Poland |
| Investigational Site | Warsaw | 02-097 | Poland |
| Investigational Site | Warsaw | 03-401 | Poland |
| Investigational Site | Wroclaw | 50-326 | Poland |
| Investigational Site | Moscow | 111020 | Russia |
| Investigational Site | Moscow | 119048 | Russia |
| Investigational Site | Moscow Region | 143405 | Russia |
| Investigational Site | Saint Petersburg | 192242 | Russia |
| Investigational Site | Saint Petersburg | Russia |
| Investigational Site | Kharkiv | 61176 | Ukraine |
| Investigational Site | Kyiv | 03110 | Ukraine |
| Investigational Site | Lviv | 79044 | Ukraine |
| Investigational Site | Zaporizhya | 69000 | Ukraine |
| Investigational Site | London | N19 5LW | United Kingdom |
| Investigational Site | London | SW10 9NH | United Kingdom |
| Wilcox M, Yan JL, Gonzalez PL, Dryden M, Stone GG, Kantecki M. Impact of Underlying Comorbidities on Outcomes of Patients Treated with Ceftaroline Fosamil for Complicated Skin and Soft Tissue Infections: Pooled Results from Three Phase III Randomized Clinical Trials. Infect Dis Ther. 2022 Feb;11(1):217-230. doi: 10.1007/s40121-021-00557-w. Epub 2021 Nov 6. |
| 30716446 | Derived | Corey GR, Wilcox MH, Gonzalez J, Jandourek A, Wilson DJ, Friedland HD, Das S, Iaconis J, Dryden M. Ceftaroline fosamil therapy in patients with acute bacterial skin and skin-structure infections with systemic inflammatory signs: A retrospective dose comparison across three pivotal trials. Int J Antimicrob Agents. 2019 Jun;53(6):830-837. doi: 10.1016/j.ijantimicag.2019.01.016. Epub 2019 Feb 1. |
| 30597021 | Derived | Cheng K, Pypstra R, Yan JL, Hammond J. Summary of the safety and tolerability of two treatment regimens of ceftaroline fosamil: 600 mg every 8 h versus 600 mg every 12 h. J Antimicrob Chemother. 2019 Apr 1;74(4):1086-1091. doi: 10.1093/jac/dky519. |
| 21115456 | Derived | Corrado ML. Integrated safety summary of CANVAS 1 and 2 trials: Phase III, randomized, double-blind studies evaluating ceftaroline fosamil for the treatment of patients with complicated skin and skin structure infections. J Antimicrob Chemother. 2010 Nov;65 Suppl 4:iv67-iv71. doi: 10.1093/jac/dkq256. |
| 21115455 | Derived | Wilcox MH, Corey GR, Talbot GH, Thye D, Friedland D, Baculik T; CANVAS 2 investigators. CANVAS 2: the second Phase III, randomized, double-blind study evaluating ceftaroline fosamil for the treatment of patients with complicated skin and skin structure infections. J Antimicrob Chemother. 2010 Nov;65 Suppl 4:iv53-iv65. doi: 10.1093/jac/dkq255. |
| 20695801 | Derived | Corey GR, Wilcox M, Talbot GH, Friedland HD, Baculik T, Witherell GW, Critchley I, Das AF, Thye D. Integrated analysis of CANVAS 1 and 2: phase 3, multicenter, randomized, double-blind studies to evaluate the safety and efficacy of ceftaroline versus vancomycin plus aztreonam in complicated skin and skin-structure infection. Clin Infect Dis. 2010 Sep 15;51(6):641-50. doi: 10.1086/655827. |
Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours.
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ceftaroline for Injection | Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours. |
| BG001 | IV Vancomycin Plus IV Aztreonam | Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours. |
| 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, Customized | Number | participants |
| |||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| Ethnicity (NIH/OMB) | 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 | Clinical Cure Rate at Test of Cure (TOC) (MITT Population) | Cure: Total resolution of all signs and symptoms of the baseline infection, or improvement of the infection such that no further antimicrobial therapy was necessary. Failure: Requirement of alternative antimicrobial therapy for primary infection of complicated skin and skin structure infection (cSSSI) due to inadequate response, recurrence, new infection at the same site; treatment-limiting adverse event (AE); requirement for surgery due to failure of study drug; diagnosis of osteomyelitis after Study Day 8; or death caused by cSSSI. Indeterminate: Inability to determine an outcome | MITT (Modified Intent to Treat) - all subjects that received any amount of study drug | Posted | Number | participants | 8-15 days after last dose of study drug administration |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | The Primary Efficacy Outcome Measure Was the Per-subject Clinical Cure Rate at the TOC Visit in the Clinically Evaluable (CE) Populations. | Not Posted | 8-15 days after last dose of study drug | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | To Evaluate the Microbiological Success Rate at the TOC Visit | Not Posted | 8-15 days after the last dose of study drug | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | To Evaluate the Clinical Response at the End of Therapy (EOT) Visit | Not Posted | last day of study drug administration | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | To Evaluate the Clinical and Microbiological Response by Pathogen at the TOC Visit | Not Posted | 8-15 days after last dose of study drug | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | To Evaluate Clinical Relapse at the Late Follow Up (LFU) Visit | Not Posted | 21 to 35 days after the last dose of study drug | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | To Evaluate Microbiological Reinfection or Recurrence at the LFU Visit | Not Posted | 21-35 days after last dose of study drug | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | To Evaluate Safety | Not Posted | first study drug dose through TOC | Participants |
Not provided
All safety analyses were performed on the Safety Population which consists of all subjects who received any amount of actual study drug.
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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 for Injection | Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours. | 14 | 341 | 144 | 341 | ||
| EG001 | IV Vancomycin Plus IV Aztreonam | Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours. | 16 | 339 | 159 | 339 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Sinoatrial block | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Anaphylactoid reaction | Immune system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Bacteremia | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Central line infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| Dislocation of joint prosthesis | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| Postprocedural hemorrhage | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Chronic lymphocytic leukemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Acute prerenal failure | Renal and urinary disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Acute pulmonary edema | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA (9.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (9.1) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Alanine aminotransferase increase | Investigations | MedDRA (9.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Systematic Assessment |
|
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Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Clinical Sciences | Cerexa, Inc. | (510) 285-9200 | clinicaltrials@cerexa.com |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D000038 | Abscess |
| D017192 | Skin Diseases, Bacterial |
| D002481 | Cellulitis |
| D013207 | Staphylococcal Skin Infections |
| D013203 | Staphylococcal Infections |
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D013492 | Suppuration |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003240 | Connective Tissue Diseases |
| D016908 | Gram-Positive Bacterial Infections |
| D014946 | Wound Infection |
| D011183 | Postoperative Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D000097583 | Ceftaroline |
| D014640 | Vancomycin |
| 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 |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008997 | Monobactams |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Indeterminate |
|