You are here

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

Last updated on January 17, 2020

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Community Acquired Pneumonia, Complicated Skin and Soft Tissue Infection
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT04198571
Pfizer
Not yet recruiting
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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Descriptive Information
Brief Title 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
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
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
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   None Retained
Description:
Not Applicable for this study
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.
Condition
  • Community Acquired Pneumonia
  • Complicated Skin and Soft Tissue Infection
Intervention Drug: Zinforo (ceftaroline fosamil)
IV Solution
Other Name: Teflaro
Study Groups/Cohorts Zinforo Treated
Only those Adults treated with this treatment for CAP or cSSTi
Intervention: Drug: Zinforo (ceftaroline fosamil)
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: December 12, 2019)
600
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04198571
Other Study ID Numbers C2661041
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
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/da....
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2019

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now