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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 the 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 for Injection | Experimental |
| |
| IV Vancomycin and IV Aztreonam | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV Vancomycin plus IV 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. |
|
| 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 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 the end of treatment |
| Clinical Cure Rate of Ceftaroline Compared With That of Vancomycin Plus Aztreonam Treatment at TOC in the Clinically Evaluable (CE) Population | 8-15 days after last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiological Success Rate at the TOC Visit | 8-15 days after last dose of study drug | |
| 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 |
|---|---|---|
| Ralph Corey, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Dothan | Alabama | 36301 | 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 February 2007 to November 2007
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| ID | Title | Description |
|---|---|---|
| FG000 | Ceftaroline Fosamil for Injection | Ceftaroline fosamil 600 mg administered IV 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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|
| Ceftaroline | Drug | 600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days |
|
|
| Clinical and Microbiological Response by Pathogen at the TOC Visit |
| 8-15 days after last dose of study drug |
| Clinical Relapse at the Late Follow Up (LFU) Visit | 21 to 35 days after the last dose of study drug |
| Microbiological Reinfection or Recurrence at the LFU Visit | 21 to 35 days after the last dose of study drug |
| Assess Safety | Comparisons of the number of participants with Adverse Events | First dose of study drug through TOC visit |
| Long Beach |
| California |
| 90813 |
| United States |
| Investigational Site | Los Angeles | California | 90015 | United States |
| Investigational Site | Sacramento | California | 95817 | United States |
| Investigational Site | Sacramento | California | 95819 | United States |
| Investigational Site | San Diego | California | 92114 | United States |
| Investigational Site | San Francisco | California | 94110 | United States |
| Investigational Site | Torrance | California | 90509 | United States |
| Investigational Site | Savannah | Georgia | 31405 | United States |
| Investigational Site | Naperville | Illinois | 60540 | United States |
| Investigational Site | Indianapolis | Indiana | 46280 | United States |
| Investigational Site | Shreveport | Louisiana | 71103 | United States |
| Investigational Site | Columbus | Ohio | 43215 | United States |
| Investigational Site | Landsdale | Pennsylvania | 19446 | United States |
| Investigational Site | Tacoma | Washington | 98405 | United States |
| Investigational Site | Buenos Aires | 1240 C1180AAX | Argentina |
| Investigational Site | Buenos Aires | 164 | Argentina |
| Investigational Site | Buenos Aires | Argentina |
| Invetigational Site | Buenos Aires | Argentina |
| Investigational Site | Córdoba | Argentina |
| Invetigational Site | Córdoba | Argentina |
| Investigational Site | Entre RÃos | Argentina |
| Investigational Site | Santa Fe | Argentina |
| Investigational Site | Curiuba-Parans | 1089 | Brazil |
| Investigational Site | São Paulo | 04039-020 | Brazil |
| Investigational Site | Santiago | Chile |
| Investigational Site | Viña del Mar | Chile |
| Investigational Site | Berlin | D-10249 | Germany |
| Investigational Site | Bochum | 44791 | Germany |
| Investigational Site | Hanau | Germany |
| Investigational Site | Plauen | 08529 | Germany |
| Investigational Site | Quedlinburg | 06484 | Germany |
| Investigational Site | Chihuahua City | 31238 | Mexico |
| Invetigational Site | Lima | 29 | Peru |
| Investigational Site | Bytom | 41-902 | Poland |
| Investigational Site | Krakow | 31-913 | Poland |
| Investigational Site | Lublin | 20-081 | Poland |
| Investigational Site | Sosnowiec | 41-200 | Poland |
| Investigational Site | Todz | 91-425 | Poland |
| Investigational Site | Bucharest | 010816 | Romania |
| Investigational Site | Bucharest | 041915 | Romania |
| Investigational Site | Timișoara | 300736 | Romania |
| Investigational Site | Moscow | 105229 | Russia |
| Investigational Site | Moscow | 111539 | Russia |
| Investigational Site | Moscow | 129327 | Russia |
| Investigational Site | Saint Petersburg | 192242 | Russia |
| Investigational Site | Saint Petersburg | 194354 | Russia |
| Investigational Site | Saint Petersburg | 196247 | Russia |
| Investigational Site | Smolensk | 214019 | Russia |
| Investigational Site | Dnipropetrovsk | 49600 | Ukraine |
| Investigational Site | Ivano-Frankivsk | 76008 | Ukraine |
| Investigational Site | Lviv | 79659 | Ukraine |
| 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. |
| 21115454 | Derived | Corey GR, Wilcox MH, Talbot GH, Thye D, Friedland D, Baculik T; CANVAS 1 investigators. CANVAS 1: the first 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:iv41-51. doi: 10.1093/jac/dkq254. |
| 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 |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ceftaroline Fosamil for Injection | Ceftaroline fosamil 600 mg administered IV 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | 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 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) - Any randomized subjects that received any amount of study drug | Posted | Number | participants | 8-15 days after the end of treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Clinical Cure Rate of Ceftaroline Compared With That of Vancomycin Plus Aztreonam Treatment at TOC in the Clinically Evaluable (CE) Population | Not Posted | 8-15 days after last dose of study drug | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Microbiological Success Rate at the TOC Visit | Not Posted | 8-15 days after last dose of study drug | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Response at the End of Therapy (EOT) Visit | Not Posted | Last day of study drug administration | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical and Microbiological Response by Pathogen at the TOC Visit | Not Posted | 8-15 days after last dose of study drug | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Relapse at the Late Follow Up (LFU) Visit | Not Posted | 21 to 35 days after the last dose of study drug | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Microbiological Reinfection or Recurrence at the LFU Visit | Not Posted | 21 to 35 days after the last dose of study drug | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Assess Safety | Comparisons of the number of participants with Adverse Events | Not Posted | First dose of study drug through TOC visit | Participants |
Not provided
All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ceftaroline Fosamil for Injection | Ceftaroline fosamil 600 mg administered IV over 60 minutes every 12 hours followed by placebo administered over 60 minutes every 12 hours | 16 | 351 | 128 | 351 | ||
| 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 | 12 | 347 | 162 | 347 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Hematochezia | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Intestinal ischemia | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Peptic ulcer hemorrhage | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Generalized edema | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Clostridial infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Renal abscess | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Electrocardiogram ST segment elevation | Investigations | MedDRA (9.1) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Transient ischemic attack | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Arterial thrombosis limb | Vascular disorders | MedDRA (9.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Pruritus generalized | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Pruritus | 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 |
| |
| Dizziness | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (9.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (9.1) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Clinical Sciences | Cerexa | (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 |
|---|---|
| D014640 | Vancomycin |
| D001398 | Aztreonam |
| D000097583 | Ceftaroline |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008997 | Monobactams |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D002511 | Cephalosporins |
| D013843 | Thiazines |
Not provided
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| <18 years |
|
| >=18 years and < 65 years |
|
| Male |
|
| Hispanic |
|
| Indeterminate |
|