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

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: Completed
• Conditions: Community Acquired Pneumonia (CAP); Complicated Skin and Skin Structures Infections (cSSSI)

• Study Type: Observational
• Enrollment (Actual): 4035

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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).

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

General Publications

• Garau J, Blasi F, Medina J, McBride K, Ostermann H; REACH study group. Early response to antibiotic treatment in European patients hospitalized with complicated skin and soft tissue infections: analysis of the REACH study. BMC Infect Dis. 2015 Feb 19;15:78. doi: 10.1186/s12879-015-0822-2.
• Blasi F, Ostermann H, Racketa J, Medina J, McBride K, Garau J; REACH study group. Early versus later response to treatment in patients with community-acquired pneumonia: analysis of the REACH study. Respir Res. 2014 Jan 22;15(1):6. doi: 10.1186/1465-9921-15-6.
• Blasi F, Garau J, Medina J, Avila M, McBride K, Ostermann H; REACH study group. Current management of patients hospitalized with community-acquired pneumonia across Europe: outcomes from REACH. Respir Res. 2013 Apr 15;14(1):44. doi: 10.1186/1465-9921-14-44.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (ACTUAL): June 1, 2011
• Study Completion (ACTUAL): June 1, 2011

Study Registration Dates

• First Submitted: February 6, 2011
• First Submitted That Met QC Criteria: February 9, 2011
• First Posted (ESTIMATE): February 10, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): September 7, 2012
• Last Update Submitted That Met QC Criteria: September 6, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: MRSA; Antibiotics; Community Acquired Pneumonia (CAP); Complicated Skin and Skin Structures Infections (cSSSI); Complicated Skin and Soft Tissues Infections (cSSTI); Infection management; Use of Resources; PRSP
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Infections; Communicable Diseases; Pneumonia; Skin Diseases, Bacterial
• Other Study ID Numbers: NIS-IEU-DUM-2010/1