Clinical trial NCT01293435: Study Evaluating Management of Patients With Community-Acquired Pneumonia (CAP) or Complicated Skin Infections
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Community Acquired Pneumonia (CAP)
Complicated Skin and Skin Structures Infections (cSSSI)
Keywords: 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
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-02-10
Enrollment: 4035
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Number of patients with infection resolution reaching clinical stability, as a measure of effectiveness
timeFrame: 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).
measure: Number of patients reaching clinical stability, as a measure of effectiveness
timeFrame: 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).
measure: Number of patients death, as a measure of clinical failure
timeFrame: 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).
measure: Number of patients with infection recurrence, as a measure of clinical failure
timeFrame: 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).
measure: Number of patients requiring change in antibiotic, as a measure of clinical failure
timeFrame: 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:
measure: 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.
timeFrame: Retrospective. Outcome measures will be determined in patients hospitalized between 2010-12-01 and 2011-01-31.
measure: Number and type of diagnostic tests, as measure of use of resources
timeFrame: 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).
measure: Type of medications used, as measure of use of resources
timeFrame: 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).
measure: Duration of hospitalisation, as measure of use of resources
timeFrame: 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).
measure: Number of patients requiring ICU / isolation / mechanical ventilation / complications, as measure of use of resources
timeFrame: 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).
measure: 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
timeFrame: 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).
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Research Site
city: Bonheiden
country: Belgium
facility: Research Site
city: Brussel
country: Belgium
facility: Research Site
city: Charleroi
country: Belgium
facility: Research Site
city: Dinant
country: Belgium
facility: Research Site
city: Edegem
country: Belgium
facility: Research Site
city: Godinne
country: Belgium
facility: Research Site
city: Hasselt
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: Mons
country: Belgium
facility: Research Site
city: Montigny-le-Tilleul
country: Belgium
facility: Research Site
city: Alencon
country: France
facility: Research Site
city: Amboise
country: France
facility: Research Site
city: Amiens
country: France
facility: Research Site
city: Bayonne
country: France
facility: Research Site
city: Bergerac
country: France
facility: Research Site
city: Briancon
country: France
facility: Research Site
city: Brive La Gaillarde
country: France
facility: Research Site
city: Cahors
country: France
facility: Research Site
city: Cayenne
country: France
facility: Research Site
city: Chambery
country: France
facility: Research Site
city: Chauny
country: France
facility: Research Site
city: Cognac
country: France
facility: Research Site
city: Colombes
country: France
facility: Research Site
city: Compiegne
country: France
facility: Research Site
city: Creil
country: France
facility: Research Site
city: Decazeville
country: France
facility: Research Site
city: Denain
country: France
facility: Research Site
city: Dunkerque
country: France
facility: Research Site
city: Eaubonne
country: France
facility: Research Site
city: Evreux
country: France
facility: Research Site
city: Fecamp
country: France
facility: Research Site
city: Hyeres
country: France
facility: Research Site
city: La Tronche
country: France
facility: Research Site
city: Lagny Sur Marne
country: France
facility: Research Site
city: Le Chesnay
country: France
facility: Research Site
city: Le Coudray
country: France
facility: Research Site
city: Le Mans
country: France
facility: Research Site
city: Lens
country: France
facility: Research Site
city: Libourne
country: France
facility: Research Site
city: Lille
country: France
facility: Research Site
city: Marseille
country: France
facility: Research Site
city: Metz
country: France
facility: Research Site
city: Montdidier
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: PAU
country: France
facility: Research Site
city: Pontarlier
country: France
facility: Research Site
city: Rethel
country: France
facility: Research Site
city: Saintes
country: France
facility: Research Site
city: Salon de Provence
country: France
facility: Research Site
city: St Aubin Les Elbeuf
country: France
facility: Research Site
city: St Brieuc
country: France
facility: Research Site
city: St Die Des Vosges
country: France
facility: Research Site
city: St Hilaire Du Harcouet
country: France
facility: Research Site
city: St Priest En Jarez
country: France
facility: Research Site
city: St Quentin
country: France
facility: Research Site
city: Strasbourg
country: France
facility: Research Site
city: Tarbes
country: France
facility: Research Site
city: Toul
country: France
facility: Research Site
city: Tulle
country: France
facility: Research Site
city: Vendome
country: France
facility: Research Site
city: Vesoul
country: France
facility: Research Site
city: Ulm
country: Germany
facility: Research Site
state: Baden-Wuerttemberg
city: Aachen
country: Germany
facility: Research Site
state: North Rhine-Westphalia
city: Bochum
country: Germany
facility: Research Site
state: North Rhine-Westphalia
city: Dortmund
country: Germany
facility: Research Site
state: North Rhine-Westphalia
city: Paderborn
country: Germany
facility: Research Site
state: North Rhine-Westphalia
city: Kiel
country: Germany
facility: Research Site
state: Schleswig-Holstein
city: Lubeck
country: Germany
facility: Research Site
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Research Site
city: Alexandroupolis
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Crete
country: Greece
facility: Research Site
city: Larissa
country: Greece
facility: Research Site
city: Piraeus
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: S.G. Rotondo
country: Italy
facility: Research Site
state: Foggia
city: Rozzano
country: Italy
facility: Research Site
state: Milano
city: Pietra Ligure
country: Italy
facility: Research Site
state: Savona
city: Borgo Roma
country: Italy
facility: Research Site
state: Verona
city: Bologna
country: Italy
facility: Research Site
city: Brescia
country: Italy
facility: Research Site
city: Catania
country: Italy
facility: Research Site
city: Catanzaro
country: Italy
facility: Research Site
city: Chieti
country: Italy
facility: Research Site
city: Cuneo
country: Italy
facility: Research Site
city: Enna
country: Italy
facility: Research Site
city: Firenze
country: Italy
facility: Research Site
city: Genova
country: Italy
facility: Research Site
city: Latina
country: Italy
facility: Research Site
city: Lodi
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Modena
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Padova
country: Italy
facility: Research Site
city: Palermo
country: Italy
facility: Research Site
city: Pavia
country: Italy
facility: Research Site
city: Pesaro
country: Italy
facility: Research Site
city: Pisa
country: Italy
facility: Research Site
city: Reggio Calabria
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Sassari
country: Italy
facility: Research Site
city: Savona
country: Italy
facility: Research Site
city: Siena
country: Italy
facility: Research Site
city: Torino
country: Italy
facility: Research Site
city: Varese
country: Italy
facility: Research Site
city: Harderwijk
country: Netherlands
facility: Research Site
state: Gelderland
city: Breda
country: Netherlands
facility: Research Site
state: Noord-Brabant
city: Nieuwegein
country: Netherlands
facility: Research Site
state: Utrecht
city: Breda
country: Netherlands
facility: Research Site
city: Groningen
country: Netherlands
facility: Research Site
city: Leiden
country: Netherlands
facility: Research Site
city: Nijmegen
country: Netherlands
facility: Research Site
city: Utrecht
country: Netherlands
facility: Research Site
city: Zoetermeer
country: Netherlands
facility: Research Site
city: Amadora
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Penafiel
country: Portugal
facility: Research Site
city: Portimao
country: Portugal
facility: Research Site
city: Torres Novas
country: Portugal
facility: Research Site
city: Viana do Castelo
country: Portugal
facility: Research Site
city: Vila Nova de Gaia
country: Portugal
facility: Research Site
city: Terrassa
country: Spain
facility: Research Site
state: Barcelona
city: Santiago de Compostela
country: Spain
facility: Research Site
state: Coruna
city: Vigo
country: Spain
facility: Research Site
state: Pontevedra
city: A Coruna
country: Spain
facility: Research Site
city: Alicante
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Cordoba
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
city: Oviedo
country: Spain
facility: Research Site
city: Palma de Mallorca
country: Spain
facility: Research Site
city: Santander
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Bolu
country: Turkey
facility: Research Site
state: Abant
city: Izmir
country: Turkey
facility: Research Site
state: Balova
city: Ankara
country: Turkey
facility: Research Site
state: Be?evler
city: Ankara
country: Turkey
facility: Research Site
state: Besevler
city: Ankara
country: Turkey
facility: Research Site
state: Bilkent
city: Izmir
country: Turkey
facility: Research Site
state: Bornova
city: ?zmir
country: Turkey
facility: Research Site
state: Bozyaka
city: Istanbul
country: Turkey
facility: Research Site
state: Capa
city: Istanbul
country: Turkey
facility: Research Site
state: Cerrahpasa
city: Ankara
country: Turkey
facility: Research Site
state: Dskapi
city: Antalya
country: Turkey
facility: Research Site
state: Dumlupinar Mevkii
city: ?stanbul
country: Turkey
facility: Research Site
state: Kartal
city: Istanbul
country: Turkey
facility: Research Site
state: Mraniye
city: Bursa
country: Turkey
facility: Research Site
state: Nilfer
city: Samsun
country: Turkey
facility: Research Site
state: Ondokuz Mayıs
city: Eskiehir
country: Turkey
facility: Research Site
state: Osmangazi
city: Ankara
country: Turkey
facility: Research Site
state: S?hhiye
city: Ankara
country: Turkey
facility: Research Site
state: Sihhiye
city: Aintree
country: United Kingdom
facility: Research Site
city: Blackpool
country: United Kingdom
facility: Research Site
city: Edinburgh
country: United Kingdom
facility: Research Site
city: Hull
country: United Kingdom
facility: Research Site
city: Leicester
country: United Kingdom
facility: Research Site
city: Liverpool
country: United Kingdom
facility: Research Site
city: Middlesborough
country: United Kingdom
facility: Research Site
city: Newcastle
country: United Kingdom
facility: Research Site
city: Winchester
country: United Kingdom
facility: Research Site
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.