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

September 6, 2012 updated by: AstraZeneca

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4035

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium
        • Research Site
      • Bonheiden, Belgium
        • Research Site
      • Brussel, Belgium
        • Research Site
      • Charleroi, Belgium
        • Research Site
      • Dinant, Belgium
        • Research Site
      • Edegem, Belgium
        • Research Site
      • Godinne, Belgium
        • Research Site
      • Hasselt, Belgium
        • Research Site
      • Liege, Belgium
        • Research Site
      • Mons, Belgium
        • Research Site
      • Montigny-le-Tilleul, Belgium
        • Research Site
  • France
      • Alencon, France
        • Research Site
      • Amboise, France
        • Research Site
      • Amiens, France
        • Research Site
      • Bayonne, France
        • Research Site
      • Bergerac, France
        • Research Site
      • Briancon, France
        • Research Site
      • Brive La Gaillarde, France
        • Research Site
      • Cahors, France
        • Research Site
      • Cayenne, France
        • Research Site
      • Chambery, France
        • Research Site
      • Chauny, France
        • Research Site
      • Cognac, France
        • Research Site
      • Colombes, France
        • Research Site
      • Compiegne, France
        • Research Site
      • Creil, France
        • Research Site
      • Decazeville, France
        • Research Site
      • Denain, France
        • Research Site
      • Dunkerque, France
        • Research Site
      • Eaubonne, France
        • Research Site
      • Evreux, France
        • Research Site
      • Fecamp, France
        • Research Site
      • Hyeres, France
        • Research Site
      • La Tronche, France
        • Research Site
      • Lagny Sur Marne, France
        • Research Site
      • Le Chesnay, France
        • Research Site
      • Le Coudray, France
        • Research Site
      • Le Mans, France
        • Research Site
      • Lens, France
        • Research Site
      • Libourne, France
        • Research Site
      • Lille, France
        • Research Site
      • Marseille, France
        • Research Site
      • Metz, France
        • Research Site
      • Montdidier, France
        • Research Site
      • PAU, France
        • Research Site
      • Paris, France
        • Research Site
      • Pontarlier, France
        • Research Site
      • Rethel, France
        • Research Site
      • Saintes, France
        • Research Site
      • Salon de Provence, France
        • Research Site
      • St Aubin Les Elbeuf, France
        • Research Site
      • St Brieuc, France
        • Research Site
      • St Die Des Vosges, France
        • Research Site
      • St Hilaire Du Harcouet, France
        • Research Site
      • St Priest En Jarez, France
        • Research Site
      • St Quentin, France
        • Research Site
      • Strasbourg, France
        • Research Site
      • Tarbes, France
        • Research Site
      • Toul, France
        • Research Site
      • Tulle, France
        • Research Site
      • Vendome, France
        • Research Site
      • Vesoul, France
        • Research Site
  • Germany
      • Berlin, Germany
        • Research Site
    • Baden-Wuerttemberg
      • Ulm, Baden-Wuerttemberg, Germany
        • Research Site
    • North Rhine-Westphalia
      • Aachen, North Rhine-Westphalia, Germany
        • Research Site
      • Bochum, North Rhine-Westphalia, Germany
        • Research Site
      • Dortmund, North Rhine-Westphalia, Germany
        • Research Site
      • Paderborn, North Rhine-Westphalia, Germany
        • Research Site
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany
        • Research Site
      • Lubeck, Schleswig-Holstein, Germany
        • Research Site
  • Greece
      • Alexandroupolis, Greece
        • Research Site
      • Athens, Greece
        • Research Site
      • Crete, Greece
        • Research Site
      • Larissa, Greece
        • Research Site
      • Piraeus, Greece
        • Research Site
      • Thessaloniki, Greece
        • Research Site
  • Italy
      • Bologna, Italy
        • Research Site
      • Brescia, Italy
        • Research Site
      • Catania, Italy
        • Research Site
      • Catanzaro, Italy
        • Research Site
      • Chieti, Italy
        • Research Site
      • Cuneo, Italy
        • Research Site
      • Enna, Italy
        • Research Site
      • Firenze, Italy
        • Research Site
      • Genova, Italy
        • Research Site
      • Latina, Italy
        • Research Site
      • Lodi, Italy
        • Research Site
      • Milano, Italy
        • Research Site
      • Modena, Italy
        • Research Site
      • Napoli, Italy
        • Research Site
      • Padova, Italy
        • Research Site
      • Palermo, Italy
        • Research Site
      • Pavia, Italy
        • Research Site
      • Pesaro, Italy
        • Research Site
      • Pisa, Italy
        • Research Site
      • Reggio Calabria, Italy
        • Research Site
      • Roma, Italy
        • Research Site
      • Sassari, Italy
        • Research Site
      • Savona, Italy
        • Research Site
      • Siena, Italy
        • Research Site
      • Torino, Italy
        • Research Site
      • Varese, Italy
        • Research Site
    • Foggia
      • S.G. Rotondo, Foggia, Italy
        • Research Site
    • Milano
      • Rozzano, Milano, Italy
        • Research Site
    • Savona
      • Pietra Ligure, Savona, Italy
        • Research Site
    • Verona
      • Borgo Roma, Verona, Italy
        • Research Site
  • Netherlands
      • Breda, Netherlands
        • Research Site
      • Groningen, Netherlands
        • Research Site
      • Leiden, Netherlands
        • Research Site
      • Nijmegen, Netherlands
        • Research Site
      • Utrecht, Netherlands
        • Research Site
      • Zoetermeer, Netherlands
        • Research Site
    • Gelderland
      • Harderwijk, Gelderland, Netherlands
        • Research Site
    • Noord-Brabant
      • Breda, Noord-Brabant, Netherlands
        • Research Site
    • Utrecht
      • Nieuwegein, Utrecht, Netherlands
        • Research Site
  • Portugal
      • Amadora, Portugal
        • Research Site
      • Lisboa, Portugal
        • Research Site
      • Penafiel, Portugal
        • Research Site
      • Portimao, Portugal
        • Research Site
      • Torres Novas, Portugal
        • Research Site
      • Viana do Castelo, Portugal
        • Research Site
      • Vila Nova de Gaia, Portugal
        • Research Site
  • Spain
      • A Coruna, Spain
        • Research Site
      • Alicante, Spain
        • Research Site
      • Barcelona, Spain
        • Research Site
      • Cordoba, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Malaga, Spain
        • Research Site
      • Oviedo, Spain
        • Research Site
      • Palma de Mallorca, Spain
        • Research Site
      • Santander, Spain
        • Research Site
      • Sevilla, Spain
        • Research Site
      • Valencia, Spain
        • Research Site
    • Barcelona
      • Terrassa, Barcelona, Spain
        • Research Site
    • Coruna
      • Santiago de Compostela, Coruna, Spain
        • Research Site
    • Pontevedra
      • Vigo, Pontevedra, Spain
        • Research Site
  • Turkey
    • Abant
      • Bolu, Abant, Turkey
        • Research Site
    • Balova
      • Izmir, Balova, Turkey
        • Research Site
    • Be?evler
      • Ankara, Be?evler, Turkey
        • Research Site
    • Besevler
      • Ankara, Besevler, Turkey
        • Research Site
    • Bilkent
      • Ankara, Bilkent, Turkey
        • Research Site
    • Bornova
      • Izmir, Bornova, Turkey
        • Research Site
    • Bozyaka
      • ?zmir, Bozyaka, Turkey
        • Research Site
    • Capa
      • Istanbul, Capa, Turkey
        • Research Site
    • Cerrahpasa
      • Istanbul, Cerrahpasa, Turkey
        • Research Site
    • Dskapi
      • Ankara, Dskapi, Turkey
        • Research Site
    • Dumlupinar Mevkii
      • Antalya, Dumlupinar Mevkii, Turkey
        • Research Site
    • Kartal
      • ?stanbul, Kartal, Turkey
        • Research Site
    • Mraniye
      • Istanbul, Mraniye, Turkey
        • Research Site
    • Nilfer
      • Bursa, Nilfer, Turkey
        • Research Site
    • Ondokuz Mayıs
      • Samsun, Ondokuz Mayıs, Turkey
        • Research Site
    • Osmangazi
      • Eskiehir, Osmangazi, Turkey
        • Research Site
    • S?hhiye
      • Ankara, S?hhiye, Turkey
        • Research Site
    • Sihhiye
      • Ankara, Sihhiye, Turkey
        • Research Site
  • United Kingdom
      • Aintree, United Kingdom
        • Research Site
      • Blackpool, United Kingdom
        • Research Site
      • Edinburgh, United Kingdom
        • Research Site
      • Hull, United Kingdom
        • Research Site
      • Leicester, United Kingdom
        • Research Site
      • Liverpool, United Kingdom
        • Research Site
      • Middlesborough, United Kingdom
        • Research Site
      • Newcastle, United Kingdom
        • Research Site
      • Winchester, United Kingdom
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
1

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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).
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
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).
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
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).
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
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).
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
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).
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
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.
Time Frame: Retrospective. Outcome measures will be determined in patients hospitalized between 2010-12-01 and 2011-01-31.
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
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).
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
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).
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
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).
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
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).
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
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).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2011

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 7, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NIS-IEU-DUM-2010/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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