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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004013-16 |
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| 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
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| 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 Test of Cure (TOC) in Modified Intent-to-treat (MITT) Analysis Set | The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline. | 7 to 20 days after the last dose of study drug |
| Clinical Response at TOC in Clinically Evaluable (CE) Analysis Set | The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline. | 7 to 20 days after the last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Per Patient Microbiological Response at TOC in Microbiologically Modified-intent-to-treat (mMITT) Analysis Set | Difference in microbiological favorable response rate at TOC in mMITT analysis set. Favorable microbiological response rate is measured by comparing TOC microbiological data to baseline microbiological data. In the absence of TOC microbiological data it is presumed from the clinical response. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Melnick, MSD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Chula Vista | California | United States | |||
| Research 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
Not provided
Not provided
Overall, 802 patients were enrolled from 111 centres in 6 regions in this study. The first patient was enrolled on 17 May 2012 and the last patient last visit was on 26 June 2014. Of 802 enrolled participants, 30 did not meet the eligibility criteria and 11 were randomized but not treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ceftaroline | Ceftaroline fosamil at 600 mg every 8 hours (q8h) |
| FG001 | Vancomycin/Aztreonam | Vancomycin Plus Aztreonam |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Vancomycin |
| Drug |
IV vancomycin 15mg/kg every 12 hours |
|
| Aztreonam | Drug | IV aztreonam 1 g every 8 hours |
|
| 7 to 20 days after the last dose of study drug |
| Per-patient Micro Response at TOC in Microbiologically Evaluable (ME) Analysis Set | Difference in microbiological favorable response rate at TOC in ME. Favourable microbiological response rate is measured by comparing TOC microbiological data to baseline microbiological data. In the absence of TOC microbiological data it is presumed from the clinical response. | 7 to 20 days after the last dose of study drug |
| Clinical Response at End of Treatment (EOT) in MITT Analysis Set | The observed difference in the clinical cure rates at EOT (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant's signs and symptoms at EOT visit to those recorded at study baseline. | On day of last dose of study drug (or + 1 day) |
| Clinical Response at EOT in CE Analysis Set | The observed difference in the clinical cure rates at EOT (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant's signs and symptoms at EOT visit to those recorded at study baseline. | On day of last dose of study drug (or +1 day) |
| Clinical Relapse at Late Follow-up (LFU) in CE Patients Who Were Cured at TOC | The observed difference in the clinical relapse rates at LFU (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical relapse rate at LFU is measured by comparing a patient's signs and symptoms at late follow-up to those when they were cured at TOC. | 21 to 42 days after the last dose of study drug |
| Early Response at 48 to 72 Hours of Treatment in MITT Analysis Set | The observed difference in the early success rates at 48 to 72 hours of treatment (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Early response rate as measured by comparing the participant's signs and symptoms at the 48-72 hour visit to those recorded at study baseline. | 48 to 72 hours after first dose of study drug |
| Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Per-pathogen microbiological response at TOC by baseline pathogen from site of skin infection in ME analysis set | 7 to 20 days after the last dose of study drug |
| Orlando |
| Florida |
| United States |
| Research Site | West Palm Beach | Florida | United States |
| Research Site | Carmel | Indiana | United States |
| Research Site | Hazard | Kentucky | United States |
| Research Site | Springfield | Massachusetts | United States |
| Research Site | Detroit | Michigan | United States |
| Research Site | Las Vegas | Nevada | United States |
| Research Site | Garden City | New York | United States |
| Research Site | Bellaire | Texas | United States |
| Research Site | Córdoba | Argentina |
| Research Site | Santa Fe | Argentina |
| Research Site | Parkville | Australia |
| Research Site | Brussels | Belgium |
| Research Site | Belo Horizonte | Brazil |
| Research Site | Passo Fundo | Brazil |
| Research Site | Salvador | Brazil |
| Research Site | São José do Rio Preto | Brazil |
| Research Site | Pleven | Bulgaria |
| Research Site | Rousse | Bulgaria |
| Research Site | Sofia | Bulgaria |
| Research Site | Temuco | Chile |
| Research Site | Viña del Mar | Chile |
| Research Site | Beijing | China |
| Research Site | Changchun | China |
| Research Site | Changsha | China |
| Research Site | Chengdu | China |
| Research Site | Chongqing | China |
| Research Site | Fuzhou | China |
| Research Site | Guangzhou | China |
| Research Site | Haikou | China |
| Research Site | Nanning | China |
| Research Site | Qingdao | China |
| Research Site | Shanghai | China |
| Research Site | Shenyang | China |
| Research Site | Shijiazhuang | China |
| Research Site | Wuhan | China |
| Research Site | Xi'an | China |
| Research Site | Slavonski Brod | Croatia |
| Research Site | Zagreb | Croatia |
| Research Site | Jihlava | Czechia |
| Research Site | Pardubice | Czechia |
| Research Site | Orléans | France |
| Research Site | Dessau | Germany |
| Research Site | Hanau | Germany |
| Research Site | Heilbronn | Germany |
| Research Site | Athens | Greece |
| Research Site | Kowloon | Hong Kong |
| Research Site | Pokfulam | Hong Kong |
| Research Site | Haifa | Israel |
| Research Site | Ramat Gan | Israel |
| Research Site | Safed | Israel |
| Research Site | Tel Aviv | Israel |
| Research Site | Milan | Italy |
| Research Site | Guadalajara | Mexico |
| Research Site | Cusco | Peru |
| Research Site | Lima | Peru |
| Research Site | Manila | Philippines |
| Research Site | Quezon City | Philippines |
| Research Site | Lodz | Poland |
| Research Site | Lublin | Poland |
| Research Site | Bucharest | Romania |
| Research Site | Moscow | Russia |
| Research Site | Perm | Russia |
| Research Site | Saint Petersburg | Russia |
| Research Site | Smolensk | Russia |
| Research Site | Vsevolozhsk | Russia |
| Research Site | Yaroslavl | Russia |
| Research Site | Benoni | South Africa |
| Research Site | Cape Town | South Africa |
| Research Site | Johannesburg | South Africa |
| Research Site | Worcester | South Africa |
| Research Site | Ansan | South Korea |
| Research Site | Deagu | South Korea |
| Research Site | Incheon | South Korea |
| Research Site | Seoul | South Korea |
| Research Site | Wŏnju | South Korea |
| Research Site | Barcelona | Spain |
| Research Site | Granada | Spain |
| Research Site | Madrid | Spain |
| Research Site | Terrassa | Spain |
| Research Site | Kaohsiung City | Taiwan |
| Research Site | Taipei | Taiwan |
| Research Site | Yung Kang City | Taiwan |
| Research Site | Ankara | Turkey (Türkiye) |
| Research Site | Diyarbakır | Turkey (Türkiye) |
| Research Site | Izmir | Turkey (Türkiye) |
| Research Site | Cherkasy | Ukraine |
| Research Site | Ivano-Frankivsk | Ukraine |
| Research Site | Kharkiv | Ukraine |
| Research Site | Odesa | 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. |
| 32607967 | Derived | Sanchez-Garcia M, Hammond J, Yan JL, Kantecki M, Ansari W, Dryden M. Baseline Characteristics and Outcomes Among Patients with Complicated Skin and Soft Tissue Infections Admitted to the Intensive Care Unit: Analysis of the Phase 3 COVERS Randomized Trial of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam. Infect Dis Ther. 2020 Sep;9(3):609-623. doi: 10.1007/s40121-020-00297-3. Epub 2020 Jun 30. |
| 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. |
| 30380060 | Derived | Das S, Li J, Iaconis J, Zhou D, Stone GG, Yan JL, Melnick D. Ceftaroline fosamil doses and breakpoints for Staphylococcus aureus in complicated skin and soft tissue infections. J Antimicrob Chemother. 2019 Feb 1;74(2):425-431. doi: 10.1093/jac/dky439. |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
|
|
761 randomized patients who received any amount of study therapy. there are 11 patients who are randomized , but didn't receive any study therapy.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ceftaroline | Ceftaroline fosamil at 600 mg every 8 hours (q8h) |
| BG001 | Vancomycin/Aztreonam | Vancomycin Plus 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 |
|
| 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 Test of Cure (TOC) in Modified Intent-to-treat (MITT) Analysis Set | The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline. | Modified intent-to-treat (MITT) | Posted | Number | Participant | 7 to 20 days after the last dose of study drug |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Clinical Response at TOC in Clinically Evaluable (CE) Analysis Set | The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline. | Clinical evaluable (CE) | Posted | Number | Participant | 7 to 20 days after the last dose of study drug |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Per Patient Microbiological Response at TOC in Microbiologically Modified-intent-to-treat (mMITT) Analysis Set | Difference in microbiological favorable response rate at TOC in mMITT analysis set. Favorable microbiological response rate is measured by comparing TOC microbiological data to baseline microbiological data. In the absence of TOC microbiological data it is presumed from the clinical response. | Microbiologically modified-intent-to-treat (mMITT) | Posted | Number | Participant | 7 to 20 days after the last dose of study drug |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Per-patient Micro Response at TOC in Microbiologically Evaluable (ME) Analysis Set | Difference in microbiological favorable response rate at TOC in ME. Favourable microbiological response rate is measured by comparing TOC microbiological data to baseline microbiological data. In the absence of TOC microbiological data it is presumed from the clinical response. | Microbiologically evaluable (ME) | Posted | Number | Participant | 7 to 20 days after the last dose of study drug |
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| Secondary | Clinical Response at End of Treatment (EOT) in MITT Analysis Set | The observed difference in the clinical cure rates at EOT (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant's signs and symptoms at EOT visit to those recorded at study baseline. | Posted | Number | Participants | On day of last dose of study drug (or + 1 day) |
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| Secondary | Clinical Response at EOT in CE Analysis Set | The observed difference in the clinical cure rates at EOT (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant's signs and symptoms at EOT visit to those recorded at study baseline. | Posted | Number | Participants | On day of last dose of study drug (or +1 day) |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Relapse at Late Follow-up (LFU) in CE Patients Who Were Cured at TOC | The observed difference in the clinical relapse rates at LFU (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical relapse rate at LFU is measured by comparing a patient's signs and symptoms at late follow-up to those when they were cured at TOC. | Posted | Number | Participants | 21 to 42 days after the last dose of study drug |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Early Response at 48 to 72 Hours of Treatment in MITT Analysis Set | The observed difference in the early success rates at 48 to 72 hours of treatment (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Early response rate as measured by comparing the participant's signs and symptoms at the 48-72 hour visit to those recorded at study baseline. | Posted | Number | Participants | 48 to 72 hours after first dose of study drug |
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| Secondary | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Per-pathogen microbiological response at TOC by baseline pathogen from site of skin infection in ME analysis set | Posted | Number | Participants | 7 to 20 days after the 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 at 600 mg every 8 hours (q8h) | 31 | 506 | 82 | 506 | ||
| EG001 | Vancomycin/Aztreonam | Vancomycin Plus Aztreonam | 15 | 255 | 46 | 255 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Diabetic gangrene | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Metal poisoning | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
| |
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Nephropathy toxic | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pulmonary haemosiderosis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Toxic epidermal necrolysis | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
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
| Male |
|
| indeterminate |
|
A two-sided 95% CI for the observed difference in the primary outcome measures (clinical cure rates) between ceftaroline group and vancomycin plus aztreonam group were calculated in both MITT and CE Populations at the TOC visit. Noninferiority was concluded if the lower limit of the 95% CI was higher than -10% in both MITT and CE Populations. |
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