NCT01293435

Brief Summary

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
4,035

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2011

Shorter than P25 for all trials

Geographic Reach
10 countries

163 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 10, 2011

Completed
19 days until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

September 7, 2012

Status Verified

September 1, 2012

Enrollment Period

3 months

First QC Date

February 6, 2011

Last Update Submit

September 6, 2012

Conditions

Keywords

Community Acquired Pneumonia (CAP)Complicated Skin and Skin Structures Infections (cSSSI)Complicated Skin and Soft Tissues Infections (cSSTI)AntibioticsInfection managementUse of ResourcesMRSAPRSP

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (6)

  • 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).

  • +1 more secondary outcomes

Study Arms (1)

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (163)

Research Site

Aalst, Belgium

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Bonheiden, Belgium

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Brussels, Belgium

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Charleroi, Belgium

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Dinant, Belgium

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Edegem, Belgium

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Godinne, Belgium

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Hasselt, Belgium

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Liège, Belgium

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Mons, Belgium

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Montigny-le-Tilleul, Belgium

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Alençon, France

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Amboise, France

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Amiens, France

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Bayonne, France

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Bergerac, France

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Briançon, France

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Brive-la-Gaillarde, France

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Cahors, France

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Cayenne, France

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Chambéry, France

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Chauny, France

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Cognac, France

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Colombes, France

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Compiègne, France

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Creil, France

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Decazeville, France

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Denain, France

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Dunkirk, France

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Eaubonne, France

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Évreux, France

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Fécamp, France

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Hyères, France

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La Tronche, France

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Lagny-sur-Marne, France

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Le Chesnay, France

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Le Coudray, France

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Le Mans, France

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Lens, France

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Libourne, France

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Lille, France

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Marseille, France

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Metz, France

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Montdidier, France

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Paris, France

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Pau, France

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Pontarlier, France

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Rethel, France

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Saint-Aubin-lès-Elbeuf, France

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Saint-Brieuc, France

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Saint-Dié, France

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Saint-Hilaire-du-Harcouët, France

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Saint-Priest-en-Jarez, France

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Saint-Quentin, France

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Saintes, France

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Salon-de-Provence, France

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Strasbourg, France

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Tarbes, France

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Toul, France

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Tulle, France

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Vendôme, France

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Vesoul, France

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Ulm, Baden-Wurttemberg, Germany

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Aachen, North Rhine-Westphalia, Germany

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Bochum, North Rhine-Westphalia, Germany

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Dortmund, North Rhine-Westphalia, Germany

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Paderborn, North Rhine-Westphalia, Germany

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Kiel, Schleswig-Holstein, Germany

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Lübeck, Schleswig-Holstein, Germany

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Berlin, State of Berlin, Germany

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Alexandroupoli, Greece

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Athens, Greece

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Crete, Greece

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Larissa, Greece

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Piraeus, Greece

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Thessaloniki, Greece

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S.G. Rotondo, Foggia, Italy

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Rozzano, Milano, Italy

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Pietra Ligure, Savona, Italy

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Borgo Roma, Verona, Italy

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Bologna, Italy

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Brescia, Italy

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Catania, Italy

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Catanzaro, Italy

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Chieti, Italy

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Cuneo, Italy

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Enna, Italy

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Florence, Italy

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Genova, Italy

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Latina, Italy

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Lodi, Italy

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Milan, Italy

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Modena, Italy

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Napoli, Italy

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Padua, Italy

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Palermo, Italy

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Pavia, Italy

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Pesaro, Italy

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Pisa, Italy

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Reggio Calabria, Italy

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Roma, Italy

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Sassari, Italy

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Savona, Italy

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Siena, Italy

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Torino, Italy

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Varese, Italy

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Harderwijk, Gelderland, Netherlands

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Breda, North Brabant, Netherlands

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Nieuwegein, Utrecht, Netherlands

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Breda, Netherlands

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Groningen, Netherlands

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Leiden, Netherlands

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Nijmegen, Netherlands

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Utrecht, Netherlands

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Zoetermeer, Netherlands

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Amadora, Portugal

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Lisbon, Portugal

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Penafiel, Portugal

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Portimão, Portugal

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Torres Novas, Portugal

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Viana do Castelo, Portugal

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Vila Nova de Gaia, Portugal

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Terrassa, Barcelona, Spain

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Santiago de Compostela, Coruna, Spain

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Vigo, Pontevedra, Spain

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A Coruña, Spain

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Alicante, Spain

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Barcelona, Spain

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Córdoba, Spain

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Madrid, Spain

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Málaga, Spain

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Oviedo, Spain

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Palma de Mallorca, Spain

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Santander, Spain

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Seville, Spain

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Valencia, Spain

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Bolu, Abant, Turkey (Türkiye)

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Izmir, Balova, Turkey (Türkiye)

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Ankara, Be?evler, Turkey (Türkiye)

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Ankara, Besevler, Turkey (Türkiye)

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Ankara, Bilkent, Turkey (Türkiye)

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Izmir, Bornova, Turkey (Türkiye)

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?zmir, Bozyaka, Turkey (Türkiye)

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Istanbul, Capa, Turkey (Türkiye)

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Istanbul, Cerrahpasa, Turkey (Türkiye)

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Ankara, Dskapi, Turkey (Türkiye)

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Antalya, Dumlupinar Mevkii, Turkey (Türkiye)

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?stanbul, Kartal, Turkey (Türkiye)

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Istanbul, Mraniye, Turkey (Türkiye)

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Bursa, Nilfer, Turkey (Türkiye)

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Samsun, Ondokuz Mayıs, Turkey (Türkiye)

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Eskiehir, Osmangazi, Turkey (Türkiye)

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Ankara, S?hhiye, Turkey (Türkiye)

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Ankara, Sihhiye, Turkey (Türkiye)

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Aintree, United Kingdom

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Blackpool, United Kingdom

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Edinburgh, United Kingdom

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Hull, United Kingdom

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Leicester, United Kingdom

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Liverpool, United Kingdom

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Middlesbrough, United Kingdom

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Newcastle, United Kingdom

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Winchester, United Kingdom

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Related Publications (3)

  • 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.

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2011

First Posted

February 10, 2011

Study Start

March 1, 2011

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

September 7, 2012

Record last verified: 2012-09

Locations