Community Acquired Pneumonia (CAP)REACHNCT01293435
Study Evaluating Management of Patients With Community-Acquired Pneumonia (CAP) or Complicated Skin Infections
An observational study of Community Acquired Pneumonia (CAP) and Complicated Skin and Skin Structures Infections (cSSSI), run by AstraZeneca at 163 sites in 10 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community Acquired Pneumonia (CAP), Complicated Skin and Skin Structures Infections (cSSSI)
- How many people
- 4,035 participants
- Where
- 163 sitesin 10 countries
- Study dates
- Mar 2011to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
163 sites in 10 countries.
163 sites in 10 countries
France51 sites
Research Site
Alençon
Research Site
Amboise
Research Site
Amiens
Research Site
Bayonne
Research Site
Bergerac
Research Site
Briançon
Research Site
Brive-la-Gaillarde
Research Site
Cahors
Research Site
Cayenne
Research Site
Chambéry
Research Site
Chauny
Research Site
Cognac
Research Site
Colombes
Research Site
Compiègne
Research Site
Creil
Research Site
Decazeville
Research Site
Denain
Research Site
Dunkirk
Research Site
Eaubonne
Research Site
Évreux
Research Site
Fécamp
Research Site
Hyères
Research Site
La Tronche
Research Site
Lagny-sur-Marne
Research Site
Le Chesnay
Research Site
Le Coudray
Research Site
Le Mans
Research Site
Lens
Research Site
Libourne
Research Site
Lille
Research Site
Marseille
Research Site
Metz
Research Site
Montdidier
Research Site
Paris
Research Site
Pau
Research Site
Pontarlier
Research Site
Rethel
Research Site
Saint-Aubin-lès-Elbeuf
Research Site
Saint-Brieuc
Research Site
Saint-Dié
Research Site
Saint-Hilaire-du-Harcouët
Research Site
Saint-Priest-en-Jarez
Research Site
Saint-Quentin
Research Site
Saintes
Research Site
Salon-de-Provence
Research Site
Strasbourg
Research Site
Tarbes
Research Site
Toul
Research Site
Tulle
Research Site
Vendôme
Research Site
Vesoul
Italy30 sites
Research Site
Bologna
Research Site
Borgo Roma, Verona
Research Site
Brescia
Research Site
Catania
Research Site
Catanzaro
Research Site
Chieti
Research Site
Cuneo
Research Site
Enna
Research Site
Florence
Research Site
Genova
Research Site
Latina
Research Site
Lodi
Research Site
Milan
Research Site
Modena
Research Site
Naples
Research Site
Padova
Research Site
Palermo
Research Site
Pavia
Research Site
Pesaro
Research Site
Pietra Ligure, Savona
Research Site
Pisa
Research Site
Reggio Calabria
Research Site
Roma
Research Site
Rozzano, Milano
Research Site
S.G. Rotondo, Foggia
Research Site
Sassari
Research Site
Savona
Research Site
Siena
Research Site
Torino
Research Site
Varese
Turkey (Türkiye)18 sites
Research Site
?stanbul, Kartal
Research Site
?zmir, Bozyaka
Research Site
Ankara, Be?evler
Research Site
Ankara, Besevler
Research Site
Ankara, Bilkent
Research Site
Ankara, Dskapi
Research Site
Ankara, S?hhiye
Research Site
Ankara, Sihhiye
Research Site
Antalya, Dumlupinar Mevkii
Research Site
Bolu, Abant
Research Site
Bursa, Nilfer
Research Site
Eskiehir, Osmangazi
Research Site
Istanbul, Capa
Research Site
Istanbul, Cerrahpasa
Research Site
Istanbul, Mraniye
Research Site
Izmir, Balova
Research Site
Izmir, Bornova
Research Site
Samsun, Ondokuz Mayıs
Spain14 sites
Research Site
A Coruña
Research Site
Alicante
Research Site
Barcelona
Research Site
Córdoba
Research Site
Madrid
Research Site
Málaga
Research Site
Oviedo
Research Site
Palma de Mallorca
Research Site
Santander
Research Site
Santiago de Compostela, Coruna
Research Site
Seville
Research Site
Terrassa, Barcelona
Research Site
Valencia
Research Site
Vigo, Pontevedra
Belgium11 sites
Research Site
Aalst
Research Site
Bonheiden
Research Site
Brussels
Research Site
Charleroi
Research Site
Dinant
Research Site
Edegem
Research Site
Godinne
Research Site
Hasselt
Research Site
Liège
Research Site
Mons
Research Site
Montigny-le-Tilleul
Netherlands9 sites
Research Site
Breda, North Brabant
Research Site
Breda
Research Site
Groningen
Research Site
Harderwijk, Gelderland
Research Site
Leiden
Research Site
Nieuwegein, Utrecht
Research Site
Nijmegen
Research Site
Utrecht
Research Site
Zoetermeer
United Kingdom9 sites
Research Site
Aintree
Research Site
Blackpool
Research Site
Edinburgh
Research Site
Hull
Research Site
Leicester
Research Site
Liverpool
Research Site
Middlesbrough
Research Site
Newcastle
Research Site
Winchester
Germany8 sites
Research Site
Aachen, North Rhine-Westphalia
Research Site
Berlin, State of Berlin
Research Site
Bochum, North Rhine-Westphalia
Research Site
Dortmund, North Rhine-Westphalia
Research Site
Kiel, Schleswig-Holstein
Research Site
Lübeck, Schleswig-Holstein
Research Site
Paderborn, North Rhine-Westphalia
Research Site
Ulm, Baden-Wurttemberg
Portugal7 sites
Research Site
Amadora
Research Site
Lisbon
Research Site
Penafiel
Research Site
Portimão
Research Site
Torres Novas
Research Site
Viana do Castelo
Research Site
Vila Nova de Gaia
Greece6 sites
Research Site
Alexandroupoli
Research Site
Athens
Research Site
Crete
Research Site
Larissa
Research Site
Piraeus
Research Site
Thessaloniki
About this study
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)
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.
- 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
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with infection resolution reaching clinical stability, as a measure of effectiveness
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Community Acquired Pneumonia (CAP)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 4,035 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01293435
- Sponsor's protocol ID
- NIS-IEU-DUM-2010/1
- Acronym
- REACH
- Status last verified
- Sep 2012
- First submitted
- 6 Feb 2011
- Last updated
- 7 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 25879713Blasi 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.
PubMed 24450444Blasi 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.
PubMed 23586347
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01293435
- Acronym / sponsor ID
- REACH / NIS-IEU-DUM-2010/1
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,035 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 10 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients hospitalised with CAP or cSSSI
Key exclusion criteria (3 listed)
- Patients already participating in clinical trials or any other interventional study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with infection resolution reaching clinical stability, as a measure of effectiveness
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
6 secondary outcomes
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2012.
- Derived from this study: PubMed 25879713Garau 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.
- Derived from this study: PubMed 24450444Blasi 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.
- Derived from this study: PubMed 23586347Blasi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
163 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Community Acquired Pneumonia (CAP) and Complicated Skin and Skin Structures Infections (cSSSI), run by AstraZeneca at 163 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 163 sites in France, Italy, Turkey (Türkiye), Spain, Belgium and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with infection resolution reaching clinical stability, as a measure of effectiveness (time frame: 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).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01293435, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2012.