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

NCT ID: NCT01293435

Last Updated: 2012-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4035 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-06-30

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.

Detailed Description

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Conditions

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

Keywords

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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

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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1

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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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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Countries

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Belgium France Germany Greece Italy Netherlands Portugal Spain Turkey (Türkiye) United Kingdom

References

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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.

Reference Type DERIVED
PMID: 25879713 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24450444 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23586347 (View on PubMed)

Other Identifiers

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NIS-IEU-DUM-2010/1

Identifier Type: -

Identifier Source: org_study_id