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Real-World Observational Study Of Zavicefta to Characterize Use Patterns (EZTEAM)

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ClinicalTrials.gov Identifier: NCT03923426
Recruitment Status : Recruiting
First Posted : April 22, 2019
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
This is a non-interventional medical chart review study aiming to examine the treatment patterns, effectiveness, and safety of ceftazidime-avibactam in approximately 8 countries (including but not limited to Austria, France, Germany, Greece, Italy, Spain, United Kingdom, Russia), with possible expansion to other countries as ceftazidime-avibactam is launched. Eligible patients are adults who have been treated with ceftazidime-avibactam in routine practice at participating sites since 01 January, 2018 onwards or since the date of launch in the country if it is posterior to 01 January, 2018. As this is an observational study, patients will be treated based on the standard of care at the discretion of their physician. No drugs will be supplied for this study and patients will receive treatment through standard local practice.

Condition or disease Intervention/treatment
Infection Other: Zavicefta Treatment

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Study Type : Observational
Estimated Enrollment : 630 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Real-World Observational Study Of Zavicefta (Ceftazidime-Avibactam) To Characterize Use Patterns, Effectiveness And Safety
Actual Study Start Date : November 27, 2018
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ceftazidime


Intervention Details:
  • Other: Zavicefta Treatment
    Non-interventional - Retrospective Chart Review


Primary Outcome Measures :
  1. Proportion of patients for each indication and reason for use of ceftazidime-avibactam [ Time Frame: Drug initiation until 60 days post-hospital discharge ]
  2. Poportion of patients for each usage pattern of ceftazidime-avibactam. [ Time Frame: Drug initiation until 60 days post-hospital discharge ]
    Usage patterns including treatment line, dose, frequency of dose, duration, and polytherapy regimens.

  3. Proportion of patients treated with ceftazidime-avibactam with defined microbiologic evidence of infection. [ Time Frame: Drug initiation until 60 days post-hospital discharge ]
  4. Proportion of patients treated with ceftazidime-avibactam with a defined source of infection. [ Time Frame: Drug initiation until 60 days post-hospital discharge ]
    Sources of infection including community-acquired infection (CAI), hospital-acquired infection (HAI) and healthcare-associated infection (HCAI).


Secondary Outcome Measures :
  1. Proportion of patients and their respective clinical outcomes of treatment with ceftazidime-avibactam [ Time Frame: Drug initiation until 60 days post-hospital discharge ]
  2. Proportion of patients and their respective safety outcomes of treatment with ceftazidime-avibactam [ Time Frame: Drug initiation until 60 days post-hospital discharge ]


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
Hospitalized patients with ≥72 hours of exposure to ceftazidime-avibactam at 42 European sites. Patients will be identified over a 12-month period and information about treatment will be abstracted from medical records after treatment completion. Patients will be followed from ceftazidime-avibactam initiation until 60 days post hospital discharge, mortality, withdrawal, or loss-to-follow-up, whichever occurs first.
Criteria

Inclusion Criteria:

  1. Hospitalized patient ≥18 years old or considered an adult in accordance with the age of majority in the participant's country of residence at the time of treatment with ceftazidime-avibactam.
  2. Patient received ≥1 dose of ceftazidime-avibactam in routine practice at participating site since 01 January, 2018 onwards or since the date of launch in the country if it is after 01 January, 2018.
  3. Patient underwent microbiologic sampling ≤5 days before the initiation of ceftazidime-avibactam (irrespective of results and actual bacteriological identification).
  4. Patient has all required essential data elements which include:

    1. Start and stop dates of ceftazidime-avibactam,
    2. Start and stop dates of prior antibiotic therapy used for the index infection,
    3. Type of combined antibiotic therapy (if applicable) and start and stop dates of any antibiotic combined with ceftazidime-avibactam.
  5. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study where required by local regulations.

Exclusion Criteria:

Patients must not meet any of the following exclusion criteria to be eligible:

  1. The patient is enrolled in any clinical trial of an investigational product. Patients who are enrolled in non-interventional studies (NISs) (e.g. registries) are eligible for inclusion.
  2. The patient has received ceftazidime-avibactam in a compassionate care program setting.
  3. The patient was exposed to ceftazidime-avibactam before use for the index infection.

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): NCT03923426


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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France
CHU Angers - Hôpital Hôtel Dieu Recruiting
Angers, France, 49100
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: NCT03923426     History of Changes
Other Study ID Numbers: C3591031
EZTEAM STUDY ( Other Identifier: Alias Study Number )
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
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.

Keywords provided by Pfizer:
ceftazidime-avibactam
Zavicefta

Additional relevant MeSH terms:
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Ceftazidime
Avibactam
Avibactam, ceftazidime drug combination
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action