Not provided
Not provided
Not provided
Not provided
Not provided
Overall study status is changed to "Terminated" due to low enrollment
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Forest Laboratories | INDUSTRY |
The purpose of this study is to evaluate the effects of Ceftaroline Fosamil versus Vancomycin plus Aztreonam in treatment of patients with complicated bacterial skin and soft tissue infections.
A Phase III, Multicentre, Randomised, Double-Blind Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600 mg every 8 hours) Versus Vancomycin Plus Aztreonam in the Treatment of Patients with Complicated Bacterial Skin and Soft Tissue Infections With Evidence of Systemic Inflammatory Response or Underlying Comorbidities
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ceftaroline fosamil | Experimental | Patients will receive 600 mg of ceftaroline fosamil administered as a 120-minute intravenous infusion very 8 hours. Each dose will be infused in a volume of 250 mL over 120-minutes followed by aztreonam placebo in a volume of 100 mL infused over 30 minutes every 8 hours. In addition vancomycin placebo will be given in a volume of 250 mL infused over 120 minutes every 12 hours. Doses will be adjusted according to the patient's renal function. |
|
| Vancomycin plus aztreonam | Active Comparator | Patients will receive combination of vancomycin plus aztreonam. Dose of vancomycin will be based on the patient's actual weight and will receive intravenous vancomycin every 12 hours with each dose infused over 120-minutes. Aztreonam dose will be 1 gram intravenously in a volume of 100 mL infused over 30 minutes every 8 hours. In addition, ceftaroline fosamil placebo will be given in a volume of 250 mL infused over 120 minutes every 8 hours. Doses adjusted according to patients renal function |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceftaroline fosamil | Drug | IV ceftaroline 600mg every 8 hours |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response at TOC | Clinical cure is defined as resolution or improvement of signs and symptoms compared to baseline and no further antimicrobial therapy is necessary. Clinical failure is defined as any of the following: persistence or worsening in signs or symptoms, or requirement for concomitant antibiotic therapy, or requirement of an unplanned surgical intervention >48 hours after the first dose, or death caused by skin infection, or an AE leading to study drug discontinuation with alternative antimicrobial therapy required, or diagnosis of osteomyelitis >=8 days after the first dose. | 7 to 20 days after last dose of study drug |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Melnick, MSD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research site | Córdoba | Argentina | ||||
| Research site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27585969 | Derived | Dryden M, Zhang Y, Wilson D, Iaconis JP, Gonzalez J. A Phase III, randomized, controlled, non-inferiority trial of ceftaroline fosamil 600 mg every 8 h versus vancomycin plus aztreonam in patients with complicated skin and soft tissue infection with systemic inflammatory response or underlying comorbidities. J Antimicrob Chemother. 2016 Dec;71(12):3575-3584. doi: 10.1093/jac/dkw333. Epub 2016 Sep 1. |
Not provided
Not provided
Not provided
Overall, 4 patients were enrolled from 2 centres in 1 regions in this study. The first patient was enrolled on 15 September 2014 and the last patient last visit was on 02 January 2015.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ceftaroline | Ceftaroline fosamil 600 mg 120 min |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| Vancomycin |
| Drug |
IV vancomycin 15mg/kg every 12 hours |
|
| Aztreonam | Drug | IV aztreonam 1 g every 8 hours |
|
| Salvador |
| Estado de Bahia |
| Brazil |
| Research site | Passo Fundo | Rio Grande do Sul | Brazil |
| Research site | São José do Rio Preto | Brazil |
| Research site | Pleven | Bulgaria |
| Research site | Temuco | Chile |
| Research site | Zagreb | Croatia |
| Research site | Athens | Greece |
| Research site | Haifa | Israel |
| Research site | Ramat Gan | Israel |
| Research site | Safed | Israel |
| Research site | Tel Aviv | Israel |
| Research site | Milan | Italy |
| Research site | Lodz | Poland |
| Research site | Bucharest | Romania |
| Research site | Dundee | South Africa |
| Research site | Worcester | South Africa |
| Research site | Granada | Spain |
| Research site | Terrassa | Spain |
| Research site | Ankara | Turkey (Türkiye) |
| Research site | Diyarbakır | Turkey (Türkiye) |
| Research site | Izmir | Turkey (Türkiye) |
| COMPLETED |
|
| NOT COMPLETED |
|
Randomized patients
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ceftaroline | Ceftaroline fosamil 600 mg 120 min |
| 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 |
| ||||||||||||||||||
| Race (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 Response at TOC | Clinical cure is defined as resolution or improvement of signs and symptoms compared to baseline and no further antimicrobial therapy is necessary. Clinical failure is defined as any of the following: persistence or worsening in signs or symptoms, or requirement for concomitant antibiotic therapy, or requirement of an unplanned surgical intervention >48 hours after the first dose, or death caused by skin infection, or an AE leading to study drug discontinuation with alternative antimicrobial therapy required, or diagnosis of osteomyelitis >=8 days after the first dose. | Randomized | Posted | Number | Participant | 7 to 20 days after last dose of study drug |
|
|
|
Adverse events were collected from time of the first dose of study drug up to TOC visit (8 to 15 days after the last dose). Serious AEs were collected from time of signature of informed consent up to the LFU visit (21 to 35 days after the last dose).
Not provided
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 | Ceftaroline fosamil 600 mg 120 min | 1 | 4 | 3 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment | SAE started at 12:00 pm on and resolved at 13:00 pm on 2014-08-08. It was reported as important medical event which was assessed as moderate and unrelated to study drug. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Urinary tract | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
Early termination leading to small number of subjects analyzed.
The investigator agrees not to use such Confidential study information and not to disclose them to any other third parties, except that the undersigned shall not be prevented from using or disclosing information: (a) which by written records was previously known; (b) which is now public knowledge, (c) which is lawfully obtained by the undersigned from sources who have a lawful right to disclose such information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yunxia Lu | AstraZeneca-PPD | 910-558-4197 | Yunxia.Lu@ppdi.com |
| ID | Term |
|---|---|
| D018461 | Soft Tissue Infections |
| D002481 | Cellulitis |
| D014946 | Wound Infection |
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| 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 |
| D001423 | Bacterial Infections and Mycoses |
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
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|