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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

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ClinicalTrials.gov Identifier: NCT04198571
Recruitment Status : Completed
First Posted : December 13, 2019
Last Update Posted : August 18, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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

Condition or disease Intervention/treatment
Community Acquired Pneumonia Complicated Skin and Soft Tissue Infection Drug: Zinforo (ceftaroline fosamil)

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: MULTINATIONAL Retrospective Chart Review Study to Assess the Characteristics, Treatment Outcomes and Resource Use Among Adult Patients Hospitalised for Community-Acquired Pneumonia (CAP) or Complicated Skin and Soft Tissue Infections (cSSTI) Treated With Zinforo (REGISTERED) (Ceftaroline Fosamil) in a Usual Care Setting
Actual Study Start Date : May 17, 2020
Actual Primary Completion Date : July 23, 2021
Actual Study Completion Date : July 23, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Group/Cohort Intervention/treatment
Zinforo Treated
Only those Adults treated with this treatment for CAP or cSSTi
Drug: Zinforo (ceftaroline fosamil)
IV Solution
Other Name: Teflaro




Primary Outcome Measures :
  1. Clinical Response to Zinforo using retrospective chart data for observational study [ Time Frame: baseline to 72 hours after treatment began anytime before May 31 2019 ]
    Using the medical charts and transcribing the data to a report form, the clinical Response to Zinforo will be measured by three possible scenarios. 1)no further intravenous (IV) antibiotic, 2) switch to an oral antibiotic, or 3)IV antibiotic treatment streamlining/de-escalation prior to discharge from the hospital

  2. Clinical Failure of Zinforo measured by using charts for a retrospective observational study [ Time Frame: baseline to 72 hours after treatment began anytime before May 31 2019 ]

    Using the medical charts collecting the data with a report form, observing which patients had clinical Failure of Zinforo defined as:

    defined as switch to another IV antibiotic due to an adverse reaction, drug-drug interaction, insufficient response, or a microbiological diagnosis indicating that the pathogen is not susceptible to Zinforo


  3. Length of Hospital Stay using chart data for a retrospective observational study [ Time Frame: The number of days from the hospital admission to discharge which on average is about 10-14 days collected anytime before May 31st 2019 ]
    Using the medical charts collecting the observational data and transcribing it to a report form, observing the length of hospital stay in days of patients diagnosed with Community Acquired Pneumonia and Complicated skin and skin structure tissue infection

  4. Mortality of patients with Community Acquired Pneumonia or Complicated Skin and Skin Structure Tissue Infection [ Time Frame: The number of patients that died at any time between Hospital Admission to Hospital Discharge who received Zinforo any time on or before May 31, 2019. ]
    Using the medical charts and transcribing the data to a report form, observing the number of patients that died with Community Acquired Pneumonia or Complicated Skin and Skin structure tissue infections


Biospecimen Retention:   None Retained
Not Applicable for this study


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The target population is adult patients aged 18 years and older hospitalized for CAP or cSSTI who received intravenous (IV) Zinforo® treatment in a usual care setting in Europe and Latin America on or before 31-May-2019.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04198571


Locations
Show Show 25 study locations
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04198571    
Other Study ID Numbers: C2661041
First Posted: December 13, 2019    Key Record Dates
Last Update Posted: August 18, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Pfizer:
Bacteria
Zinforo® (ceftaroline fosamil)
CAP
cSSTi
Hospitalized
Infectious Disease
Antibiotic
Cephalosporin
Additional relevant MeSH terms:
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Infection
Soft Tissue Infections
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Ceftaroline fosamil
Anti-Bacterial Agents
Anti-Infective Agents