Study Evaluating Management of Patients With Community-Acquired Pneumonia (CAP) or Complicated Skin Infections

Study Overview
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Brief Summary
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This study will collect real-life data from patients with community acquired pneumonia (CAP) OR complicated skin and skin structure infections (cSSSI) to assess the burden of the disease, review the treatment pathways, evaluate how health resources are used and identify any areas of unmet medical needs. The aim of the study is to compare how patients who are admitted to hospital with CAP or cSSSI are managed across Europe. This will be done by collecting data to understand the patient and disease characteristics, current practice of treatment, and outcomes for the patient. Overall 4000 patients will be recruited from 10 European countries.

Official Title
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Observational Study to Assess Clinical Management Patterns in Patients With Hospitalised Community-Acquired Pneumonia (CAP) or Complicated Skin and Skin Structure Infections (cSSSI)

Conditions
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Community Acquired Pneumonia (CAP), Complicated Skin and Skin Structures Infections (cSSSI)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients hospitalised with CAP or cSSSI CAP: Radiographically-confirmed bacterial pneumonia AND Requiring treatment with IV antimicrobials as start-up therapy cSSSI: Affecting deeper soft tissue and/or requiring significant surgical intervention or developing an abcess/ulcer/cellulitis in a lower limb AND Having at least two local signs and one systemic sign of cSSS AND Treatment with antimicrobials Exclusion Criteria: Patients already participating in clinical trials or any other interventional study. CAP: CAP suitable for outpatient therapy with an oral antimicrobial agent. cSSSI: Uncomplicated SSSI. Skin and skin-structure infections with a high cure rate after surgical incision alone or after aggressive local skin care.

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 |
| --- | --- |
| 1<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with infection resolution reaching clinical stability, as a measure of effectiveness |  | Retrospective. Outcome measures will be determined in patients hospitalized between 2010-12-01 and 2011-01-31, from the date of hospitalization, up to the date of hospital discharge (2011-02-28 at the latest). | 
| Number of patients reaching clinical stability, as a measure of effectiveness |  | Retrospective. Outcome measures will be determined in patients hospitalized between 2010-12-01 and 2011-01-31, from the date of hospitalization, up to the date of hospital discharge (2011-02-28 at the latest). | 
| Number of patients death, as a measure of clinical failure |  | Retrospective. Outcome measures will be determined in patients hospitalized between 2010-12-01 and 2011-01-31, from the date of hospitalization, up to the date of hospital discharge (2011-02-28 at the latest). | 
| Number of patients with infection recurrence, as a measure of clinical failure |  | Retrospective. Outcome measures will be determined in patients hospitalized between 2010-12-01 and 2011-01-31, from the date of hospitalization, up to the date of hospital discharge (2011-02-28 at the latest). | 
| Number of patients requiring change in antibiotic, as a measure of clinical failure |  | Retrospective. Outcome measures will be determined in patients hospitalized between 2010-12-01 and 2011-01-31, from the date of hospitalization, up to the date of hospital discharge (2011-02-28 at the latest). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients hospitalized with CAP or cSSSI, in each type of hospital and department, as a descriptive measure of burden of disease, and patient flow. |  | Retrospective. Outcome measures will be determined in patients hospitalized between 2010-12-01 and 2011-01-31. | 
| Number and type of diagnostic tests, as measure of use of resources |  | Retrospective. Outcome measures will be determined in patients hospitalized between 2010-12-01 and 2011-01-31, from the date of hospitalization, up to the date of hospital discharge (2011-02-28 at the latest). | 
| Type of medications used, as measure of use of resources |  | Retrospective. Outcome measures will be determined in patients hospitalized between 2010-12-01 and 2011-01-31, from the date of hospitalization, up to the date of hospital discharge (2011-02-28 at the latest). | 
| Duration of hospitalisation, as measure of use of resources |  | Retrospective. Outcome measures will be determined in patients hospitalized between 2010-12-01 and 2011-01-31, from the date of hospitalization, up to the date of hospital discharge (2011-02-28 at the latest). | 
| Number of patients requiring ICU / isolation / mechanical ventilation / complications, as measure of use of resources |  | Retrospective. Outcome measures will be determined in patients hospitalized between 2010-12-01 and 2011-01-31, from the date of hospitalization, up to the date of hospital discharge (2011-02-28 at the latest). | 
| No. patients infected with MR-Staphylococcus aureus in cSSSI, or with PR-Streptococcus pneumoniae in CAP, not responding to antibiotic treatment, as measure of prevalence of resistant strains and of incidence of associated clinical failure |  | Retrospective. Outcome measures will be determined in patients hospitalized between 2010-12-01 and 2011-01-31, from the date of hospitalization, up to the date of hospital discharge (2011-02-28 at the latest). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Community Acquired Pneumonia (CAP), Complicated Skin and Skin Structures Infections (cSSSI), Complicated Skin and Soft Tissues Infections (cSSTI), Antibiotics, Infection management, Use of Resources, MRSA, PRSP