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

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT01293435
Collaborator
(none)
4,035
Enrollment
163
Locations
3
Duration (Months)
24.8
Patients Per Site
8.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    4035 participants
    Time Perspective:
    Retrospective
    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 Start Date :
    Mar 1, 2011
    Actual Primary Completion Date :
    Jun 1, 2011
    Actual Study Completion Date :
    Jun 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    1

    Outcome Measures

    Primary Outcome Measures

    1. 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).]

    2. 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).]

    3. 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).]

    4. 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).]

    5. 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 Outcome Measures

    1. 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.]

    2. 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).]

    3. 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).]

    4. 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).]

    5. 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).]

    6. 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).]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Aalst Belgium
    2 Research Site Bonheiden Belgium
    3 Research Site Brussel Belgium
    4 Research Site Charleroi Belgium
    5 Research Site Dinant Belgium
    6 Research Site Edegem Belgium
    7 Research Site Godinne Belgium
    8 Research Site Hasselt Belgium
    9 Research Site Liege Belgium
    10 Research Site Mons Belgium
    11 Research Site Montigny-le-Tilleul Belgium
    12 Research Site Alencon France
    13 Research Site Amboise France
    14 Research Site Amiens France
    15 Research Site Bayonne France
    16 Research Site Bergerac France
    17 Research Site Briancon France
    18 Research Site Brive La Gaillarde France
    19 Research Site Cahors France
    20 Research Site Cayenne France
    21 Research Site Chambery France
    22 Research Site Chauny France
    23 Research Site Cognac France
    24 Research Site Colombes France
    25 Research Site Compiegne France
    26 Research Site Creil France
    27 Research Site Decazeville France
    28 Research Site Denain France
    29 Research Site Dunkerque France
    30 Research Site Eaubonne France
    31 Research Site Evreux France
    32 Research Site Fecamp France
    33 Research Site Hyeres France
    34 Research Site La Tronche France
    35 Research Site Lagny Sur Marne France
    36 Research Site Le Chesnay France
    37 Research Site Le Coudray France
    38 Research Site Le Mans France
    39 Research Site Lens France
    40 Research Site Libourne France
    41 Research Site Lille France
    42 Research Site Marseille France
    43 Research Site Metz France
    44 Research Site Montdidier France
    45 Research Site Paris France
    46 Research Site PAU France
    47 Research Site Pontarlier France
    48 Research Site Rethel France
    49 Research Site Saintes France
    50 Research Site Salon de Provence France
    51 Research Site St Aubin Les Elbeuf France
    52 Research Site St Brieuc France
    53 Research Site St Die Des Vosges France
    54 Research Site St Hilaire Du Harcouet France
    55 Research Site St Priest En Jarez France
    56 Research Site St Quentin France
    57 Research Site Strasbourg France
    58 Research Site Tarbes France
    59 Research Site Toul France
    60 Research Site Tulle France
    61 Research Site Vendome France
    62 Research Site Vesoul France
    63 Research Site Ulm Baden-Wuerttemberg Germany
    64 Research Site Aachen North Rhine-Westphalia Germany
    65 Research Site Bochum North Rhine-Westphalia Germany
    66 Research Site Dortmund North Rhine-Westphalia Germany
    67 Research Site Paderborn North Rhine-Westphalia Germany
    68 Research Site Kiel Schleswig-Holstein Germany
    69 Research Site Lubeck Schleswig-Holstein Germany
    70 Research Site Berlin Germany
    71 Research Site Alexandroupolis Greece
    72 Research Site Athens Greece
    73 Research Site Crete Greece
    74 Research Site Larissa Greece
    75 Research Site Piraeus Greece
    76 Research Site Thessaloniki Greece
    77 Research Site S.G. Rotondo Foggia Italy
    78 Research Site Rozzano Milano Italy
    79 Research Site Pietra Ligure Savona Italy
    80 Research Site Borgo Roma Verona Italy
    81 Research Site Bologna Italy
    82 Research Site Brescia Italy
    83 Research Site Catania Italy
    84 Research Site Catanzaro Italy
    85 Research Site Chieti Italy
    86 Research Site Cuneo Italy
    87 Research Site Enna Italy
    88 Research Site Firenze Italy
    89 Research Site Genova Italy
    90 Research Site Latina Italy
    91 Research Site Lodi Italy
    92 Research Site Milano Italy
    93 Research Site Modena Italy
    94 Research Site Napoli Italy
    95 Research Site Padova Italy
    96 Research Site Palermo Italy
    97 Research Site Pavia Italy
    98 Research Site Pesaro Italy
    99 Research Site Pisa Italy
    100 Research Site Reggio Calabria Italy
    101 Research Site Roma Italy
    102 Research Site Sassari Italy
    103 Research Site Savona Italy
    104 Research Site Siena Italy
    105 Research Site Torino Italy
    106 Research Site Varese Italy
    107 Research Site Harderwijk Gelderland Netherlands
    108 Research Site Breda Noord-Brabant Netherlands
    109 Research Site Nieuwegein Utrecht Netherlands
    110 Research Site Breda Netherlands
    111 Research Site Groningen Netherlands
    112 Research Site Leiden Netherlands
    113 Research Site Nijmegen Netherlands
    114 Research Site Utrecht Netherlands
    115 Research Site Zoetermeer Netherlands
    116 Research Site Amadora Portugal
    117 Research Site Lisboa Portugal
    118 Research Site Penafiel Portugal
    119 Research Site Portimao Portugal
    120 Research Site Torres Novas Portugal
    121 Research Site Viana do Castelo Portugal
    122 Research Site Vila Nova de Gaia Portugal
    123 Research Site Terrassa Barcelona Spain
    124 Research Site Santiago de Compostela Coruna Spain
    125 Research Site Vigo Pontevedra Spain
    126 Research Site A Coruna Spain
    127 Research Site Alicante Spain
    128 Research Site Barcelona Spain
    129 Research Site Cordoba Spain
    130 Research Site Madrid Spain
    131 Research Site Malaga Spain
    132 Research Site Oviedo Spain
    133 Research Site Palma de Mallorca Spain
    134 Research Site Santander Spain
    135 Research Site Sevilla Spain
    136 Research Site Valencia Spain
    137 Research Site Bolu Abant Turkey
    138 Research Site Izmir Balova Turkey
    139 Research Site Ankara Be?evler Turkey
    140 Research Site Ankara Besevler Turkey
    141 Research Site Ankara Bilkent Turkey
    142 Research Site Izmir Bornova Turkey
    143 Research Site ?zmir Bozyaka Turkey
    144 Research Site Istanbul Capa Turkey
    145 Research Site Istanbul Cerrahpasa Turkey
    146 Research Site Ankara Dskapi Turkey
    147 Research Site Antalya Dumlupinar Mevkii Turkey
    148 Research Site ?stanbul Kartal Turkey
    149 Research Site Istanbul Mraniye Turkey
    150 Research Site Bursa Nilfer Turkey
    151 Research Site Samsun Ondokuz Mayıs Turkey
    152 Research Site Eskiehir Osmangazi Turkey
    153 Research Site Ankara S?hhiye Turkey
    154 Research Site Ankara Sihhiye Turkey
    155 Research Site Aintree United Kingdom
    156 Research Site Blackpool United Kingdom
    157 Research Site Edinburgh United Kingdom
    158 Research Site Hull United Kingdom
    159 Research Site Leicester United Kingdom
    160 Research Site Liverpool United Kingdom
    161 Research Site Middlesborough United Kingdom
    162 Research Site Newcastle United Kingdom
    163 Research Site Winchester United Kingdom

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT01293435
    Other Study ID Numbers:
    • NIS-IEU-DUM-2010/1
    First Posted:
    Feb 10, 2011
    Last Update Posted:
    Sep 7, 2012
    Last Verified:
    Sep 1, 2012
    Keywords provided by AstraZeneca
    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
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Pneumonia
    Skin Diseases, Bacterial

    Study Results

    No Results Posted as of Sep 7, 2012