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

Community Acquired Pneumonia (CAP) Clinical Trial

— REACH  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01293435
• Other study ID #: NIS-IEU-DUM-2010/1
• Status: Completed
• Phase: N/A
• First received: February 6, 2011
• Last updated: September 6, 2012
• Start date: March 2011
• Est. completion date: June 2011

Study information

• Verified date: September 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review BoardFrance: Institutional Ethical CommitteeFrance: French Data Protection AuthorityFrance: Conseil National de l'Ordre des MédecinsGermany: Ethics CommissionGreece: Ministry of Health and WelfareGreece: Ethics CommitteeItaly: Ethics CommitteeNetherlands: Independent Ethics CommitteePortugal: Ethics Committee for Clinical ResearchSpain: Spanish Agency of MedicinesSpain: Ethics CommitteeTurkey: Ministry of HealthUnited Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4035
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Communicable Diseases
• Community Acquired Pneumonia (CAP)
• Complicated Skin and Skin Structures Infections (cSSSI)
• Infection
• Pneumonia

Locations

Country	Name	City	State
Belgium	Research Site	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
France	Research Site	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	Paris
France	Research Site	PAU
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
Germany	Research Site	Aachen	North Rhine-Westphalia
Germany	Research Site	Berlin
Germany	Research Site	Bochum	North Rhine-Westphalia
Germany	Research Site	Dortmund	North Rhine-Westphalia
Germany	Research Site	Kiel	Schleswig-Holstein
Germany	Research Site	Lubeck	Schleswig-Holstein
Germany	Research Site	Paderborn	North Rhine-Westphalia
Germany	Research Site	Ulm	Baden-Wuerttemberg
Greece	Research Site	Alexandroupolis
Greece	Research Site	Athens
Greece	Research Site	Crete
Greece	Research Site	Larissa
Greece	Research Site	Piraeus
Greece	Research Site	Thessaloniki
Italy	Research Site	Bologna
Italy	Research Site	Borgo Roma	Verona
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	Pietra Ligure	Savona
Italy	Research Site	Pisa
Italy	Research Site	Reggio Calabria
Italy	Research Site	Roma
Italy	Research Site	Rozzano	Milano
Italy	Research Site	S.G. Rotondo	Foggia
Italy	Research Site	Sassari
Italy	Research Site	Savona
Italy	Research Site	Siena
Italy	Research Site	Torino
Italy	Research Site	Varese
Netherlands	Research Site	Breda
Netherlands	Research Site	Breda	Noord-Brabant
Netherlands	Research Site	Groningen
Netherlands	Research Site	Harderwijk	Gelderland
Netherlands	Research Site	Leiden
Netherlands	Research Site	Nieuwegein	Utrecht
Netherlands	Research Site	Nijmegen
Netherlands	Research Site	Utrecht
Netherlands	Research Site	Zoetermeer
Portugal	Research Site	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
Spain	Research Site	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	Santiago de Compostela	Coruna
Spain	Research Site	Sevilla
Spain	Research Site	Terrassa	Barcelona
Spain	Research Site	Valencia
Spain	Research Site	Vigo	Pontevedra
Turkey	Research Site	?stanbul	Kartal
Turkey	Research Site	?zmir	Bozyaka
Turkey	Research Site	Ankara	Dskapi
Turkey	Research Site	Ankara	Be?evler
Turkey	Research Site	Ankara	Besevler
Turkey	Research Site	Ankara	Bilkent
Turkey	Research Site	Ankara	S?hhiye
Turkey	Research Site	Ankara	Sihhiye
Turkey	Research Site	Antalya	Dumlupinar Mevkii
Turkey	Research Site	Bolu	Abant
Turkey	Research Site	Bursa	Nilfer
Turkey	Research Site	Eskiehir	Osmangazi
Turkey	Research Site	Istanbul	Mraniye
Turkey	Research Site	Istanbul	Capa
Turkey	Research Site	Istanbul	Cerrahpasa
Turkey	Research Site	Izmir	Bornova
Turkey	Research Site	Izmir	Balova
Turkey	Research Site	Samsun	Ondokuz Mayis
United Kingdom	Research Site	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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Greece,  Italy,  Netherlands,  Portugal,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	No
Primary	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).	No
Primary	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).	No
Primary	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).	No
Primary	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).	No
Secondary	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.	No
Secondary	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).	No
Secondary	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).	No
Secondary	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).	No
Secondary	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
Secondary	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).	No