Retrospective Chart Review Study to Assess Characteristics, Treatment Outcomes and Resource Use of Adults Hospitalized for CAP and CSSTi Treated With Zinforo in Multiple Countries

Study Overview
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Brief Summary
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MULTINATIONAL Retrospective Chart Review Study to Assess the Characteristics, Treatment Outcomes and Resource Use Among Adult Patients Hospitalized for Community-Acquired Pneumonia (CAP) or Complicated Skin and Soft Tissue Infections (cSSTI) Treated with Zinforo® (ceftaroline fosamil) in a Usual Care Setting

Detailed Description
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The overall study aim is to provide real world evidence (RWE) on the characteristics, clinical management, treatment outcomes and healthcare resource use of adult patients aged 18 years and older admitted to the hospital for CAP or cSSTI who received Zinforo® in a usual care setting in Europe and Latin America on or before 31-May-2019.

Official Title
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MULTINATIONAL Retrospective Chart Review Study to Assess the Characteristics, Treatment Outcomes and Resource Use Among Adult Patients Hospitalised for Community-Acquired Pneumonia (CAP) or Complicated Skin and Soft Tissue Infections (cSSTI) Treated With Zinforo (REGISTERED) (Ceftaroline Fosamil) in a Usual Care Setting

Conditions
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Community Acquired Pneumonia, Complicated Skin and Soft Tissue Infection

Intervention / Treatment
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* Drug: Zinforo (ceftaroline fosamil)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Age 18 years or older at admission date to the hospital; Received four (4) or more consecutive IV doses of Zinforo® in usual care on or before 31-May-2019; and Admitting diagnosis to the hospital was either CAP or cSSTI. Exclusion criteria: Patients who were participating in an interventional clinical trial during the same hospital admission in which Zinforo® was administered; Patients whose hospital medical records are missing documentation of the diagnostic criteria for either cSSTI or CAP; Patients whose hospital medical records are missing details of dosing with Zinforo®; Patients whose hospital medical records are missing information on the success/failure of Zinforo® treatment and the reason why treatment was discontinued; and Patients whose hospital medical records are missing discharge date and status information.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Zinforo Treated<br>Only those Adults treated with this treatment for CAP or cSSTi | Drug: Zinforo (ceftaroline fosamil)<br>* IV Solution<br>* Other names: Teflaro;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Response to Zinforo using retrospective chart data for observational study | Using the medical charts and transcribing the data to a report form, the clinical Response to Zinforo will be measured by three possible scenarios. 1)no further intravenous (IV) antibiotic, 2) switch to an oral antibiotic, or 3)IV antibiotic treatment streamlining/de-escalation prior to discharge from the hospital | baseline to 72 hours after treatment began anytime before May 31 2019 | 
| Clinical Failure of Zinforo measured by using charts for a retrospective observational study | Using the medical charts collecting the data with a report form, observing which patients had clinical Failure of Zinforo defined as: defined as switch to another IV antibiotic due to an adverse reaction, drug-drug interaction, insufficient response, or a microbiological diagnosis indicating that the pathogen is not susceptible to Zinforo | baseline to 72 hours after treatment began anytime before May 31 2019 | 
| Length of Hospital Stay using chart data for a retrospective observational study | Using the medical charts collecting the observational data and transcribing it to a report form, observing the length of hospital stay in days of patients diagnosed with Community Acquired Pneumonia and Complicated skin and skin structure tissue infection | The number of days from the hospital admission to discharge which on average is about 10-14 days collected anytime before May 31st 2019 | 
| Mortality of patients with Community Acquired Pneumonia or Complicated Skin and Skin Structure Tissue Infection | Using the medical charts and transcribing the data to a report form, observing the number of patients that died with Community Acquired Pneumonia or Complicated Skin and Skin structure tissue infections | The number of patients that died at any time between Hospital Admission to Hospital Discharge who received Zinforo any time on or before May 31, 2019. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bacteria, Zinforo® (ceftaroline fosamil), CAP, cSSTi, Hospitalized, Infectious Disease, Antibiotic, Cephalosporin