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

Purpose

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.

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

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

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Pneumonia

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Number of patients with infection resolution reaching clinical stability, as a measure of effectiveness [ Time Frame: 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). ] [ Designated as safety issue: No ]
Number of patients reaching clinical stability, as a measure of effectiveness [ Time Frame: 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). ] [ Designated as safety issue: No ]
Number of patients death, as a measure of clinical failure [ Time Frame: 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). ] [ Designated as safety issue: No ]
Number of patients with infection recurrence, as a measure of clinical failure [ Time Frame: 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). ] [ Designated as safety issue: No ]
Number of patients requiring change in antibiotic, as a measure of clinical failure [ Time Frame: 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). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: Retrospective. Outcome measures will be determined in patients hospitalized between 2010-12-01 and 2011-01-31. ] [ Designated as safety issue: No ]
Number and type of diagnostic tests, as measure of use of resources [ Time Frame: 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). ] [ Designated as safety issue: No ]
Type of medications used, as measure of use of resources [ Time Frame: 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). ] [ Designated as safety issue: No ]
Duration of hospitalisation, as measure of use of resources [ Time Frame: 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). ] [ Designated as safety issue: No ]
Number of patients requiring ICU / isolation / mechanical ventilation / complications, as measure of use of resources [ Time Frame: 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). ] [ Designated as safety issue: No ]
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 [ Time Frame: 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). ] [ Designated as safety issue: No ]

Enrollment:	4035
Study Start Date:	March 2011
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
1

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients over 18, diagnosed with community acquired pneumonia or complicated skin and skin structure infection hospitalised between 2010-12-01 and 2011-01-31.

Criteria

Inclusion Criteria:

Patients hospitalised with CAP or cSSSI
1. CAP: Radiographically-confirmed bacterial pneumonia AND Requiring treatment with IV antimicrobials as start-up therapy
2. 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.
1. CAP: CAP suitable for outpatient therapy with an oral antimicrobial agent.
2. cSSSI: Uncomplicated SSSI. Skin and skin-structure infections with a high cure rate after surgical incision alone or after aggressive local skin care.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01293435

Show 163 Study Locations

Sponsors and Collaborators

AstraZeneca

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01293435 History of Changes
Other Study ID Numbers:	NIS-IEU-DUM-2010/1
Study First Received:	February 6, 2011
Last Updated:	September 6, 2012
Health Authority:	Belgium: Institutional Review Board France: Institutional Ethical Committee France: French Data Protection Authority France: Conseil National de l'Ordre des Médecins Germany: Ethics Commission Greece: Ministry of Health and Welfare Greece: Ethics Committee Italy: Ethics Committee Netherlands: Independent Ethics Committee Portugal: Ethics Committee for Clinical Research Spain: Spanish Agency of Medicines Spain: Ethics Committee Turkey: Ministry of Health United Kingdom: Research Ethics Committee

Keywords provided by AstraZeneca:

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

Additional relevant MeSH terms:

Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on May 23, 2013

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