Retrospective Chart Review Study to Assess Characteristics, Treatment Outcomes and Resource Use of Adults Hospitalized for CAP and CSSTi Treated With Zinforo in Multiple Countries

NCT ID: NCT04198571

Last Updated: 2024-03-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

317 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-17

Study Completion Date

2021-08-30

Brief Summary

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MULTINATIONAL Retrospective Chart Review Study to Assess the Characteristics, Treatment Outcomes and Resource Use Among Adult Patients Hospitalized for Community-Acquired Pneumonia (CAP) or Complicated Skin and Soft Tissue Infections (cSSTI) Treated with Zinforo® (ceftaroline fosamil) in a Usual Care Setting

Detailed Description

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The overall study aim is to provide real world evidence (RWE) on the characteristics, clinical management, treatment outcomes and healthcare resource use of adult patients aged 18 years and older admitted to the hospital for CAP or cSSTI who received Zinforo® in a usual care setting in Europe and Latin America on or before 31-May-2019.

Conditions

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Community Acquired Pneumonia Complicated Skin and Soft Tissue Infection

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Zinforo Treated

Only those Adults treated with this treatment for CAP or cSSTi

Zinforo (ceftaroline fosamil)

Intervention Type DRUG

IV Solution

Interventions

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Zinforo (ceftaroline fosamil)

IV Solution

Intervention Type DRUG

Other Intervention Names

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Teflaro

Eligibility Criteria

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Inclusion Criteria

1. Age 18 years or older at admission date to the hospital;
2. Received four (4) or more consecutive IV doses of Zinforo® in usual care on or before 31-May-2019; and
3. Admitting diagnosis to the hospital was either CAP or cSSTI.

Exclusion Criteria

1. Patients who were participating in an interventional clinical trial during the same hospital admission in which Zinforo® was administered;
2. Patients whose hospital medical records are missing documentation of the diagnostic criteria for either cSSTI or CAP;
3. Patients whose hospital medical records are missing details of dosing with Zinforo®;
4. Patients whose hospital medical records are missing information on the success/failure of Zinforo® treatment and the reason why treatment was discontinued; and
5. Patients whose hospital medical records are missing discharge date and status information.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Real Hospital Português de Beneficência

Recife, Pernambuco, Brazil

Site Status

Hospital Esperança

Recife, , Brazil

Site Status

Clínica Las Américas

Medellín, Antioquia, Colombia

Site Status

E.S.E. Hospital Universitario San Jorge de Pereira

Pereira, Risaralda Department, Colombia

Site Status

Fundación Valle del Lili

Cali, Valle del Cauca Department, Colombia

Site Status

Centro médico Imbanaco

Cali, , Colombia

Site Status

CHU Francois Mitterrand

Dijon, , France

Site Status

CHU de Grenoble Alpes

Grenoble, , France

Site Status

Croix-Rousse hospital, Hospices Civils de Lyon

Lyon, , France

Site Status

CHU Nantes

Nantes, , France

Site Status

Attikon University General Hospital

Athens, , Greece

Site Status

University Hospital of Heraklion

Heraklion, , Greece

Site Status

General University Hospital of Larissa

Larissa, , Greece

Site Status

Patras University Medical School

Pátrai, , Greece

Site Status

AHEPA General University Hospital of Thessaloniki

Thessaloniki, , Greece

Site Status

Asst Spedali Civili Brescia and Universita Degli Studi di Brescia

Brescia, Other, Italy

Site Status

AORN Ospedali dei Colli - Ospedale Monaldi

Napoli, Other, Italy

Site Status

Azienda Ospedaliera Dei Colli

Napoli, , Italy

Site Status

Aou Citta Della Salute E Della Scienza Scdu Malattie Infettive 2

Turin, , Italy

Site Status

Azienda Sanitaria Universitaria Friuli Centrale (ASU FC), Presidio Ospedaliero Universitario Santa

Udine, , Italy

Site Status

Republican Clinical Hospital named after G.G. Kuvatova

Ufa, Bashkortostan Republic, Russia

Site Status

BUZ UR First Republican Clinical Hospital under the Ministry of Healthcare of Udmurt Republic UR

Izhevsk, Udmurtiya Republic, Russia

Site Status

Hospital Clínic

Barcelona, , Spain

Site Status

Hospital Universitario Valle de Hebrón

Barcelona, , Spain

Site Status

Hospital Ramon y Cajal

Madrid, , Spain

Site Status

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status

Countries

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Brazil Colombia France Greece Italy Russia Spain

References

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Ferry T, Gogos C, Soriano A, Blasi F, Ansari W, Kantecki M, Schweikert B, Luna G, Bassetti M. Real-World Use and Treatment Outcomes of Ceftaroline Fosamil in Patients with Complicated Skin and Soft Tissue Infection: A Multinational Retrospective Study. Infect Drug Resist. 2024 Jul 4;17:2773-2783. doi: 10.2147/IDR.S455515. eCollection 2024.

Reference Type DERIVED
PMID: 38979062 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C2661041

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Other Identifiers

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C2661041

Identifier Type: -

Identifier Source: org_study_id

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