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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/19/2021.

Real-World Observational Study Of Zavicefta to Characterize Use Patterns

Clinicaltrials.gov identifier NCT03923426

Recruitment Status Recruiting

First Posted April 22, 2019

Last update posted August 12, 2020

Study Description

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 12 countries (including but not limited to Austria, France, Germany, Greece, Italy, Spain, United Kingdom, Russia, Argentina, Colombia, Brazil, and Mexico), 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:Infection
  • Intervention/Treatment: Other: Zavicefta Treatment
  • Phase: N/A
Detailed Description

This observational study will include approximately 700 hospitalized patients with a gram-negative infection, who have received at least one dose of ceftazidime-avibactam. Patients will be recruited in approximately 62 sites across 12 countries in Europe (including Russia) and Latin America. Patients will be followed from ceftazidime-avibactam initiation until 60 days post hospital discharge, mortality, withdrawal from the study, or loss-to-follow-up, whichever occurs first. Data will be abstracted from medical records using an electronic case report form (eCRF). Baseline data include patient socio-demographics, medical history, and clinical and microbiological characteristics of the infection treated. Follow-up data will include details of treatment over time and clinical, microbiological, and healthcare resource utilization outcomes. Evaluation of clinical success will be performed in patients with at least ≥72 hours of exposure to ceftazidime-avibactam. Safety will be evaluated in all patients exposed to at least one dose of the product.

Study Design
  • Study Type: Observational
  • Estimated Enrollment: 700 participants
  • Observational Model: Case-Only
  • Time Perspective: Retrospective
  • Official Title: Real-World Observational Study of Zavicefta (Registered) (Ceftazidime-avibactam) to Characterize Use Patterns, Effectiveness and Safety - EZTEAM Study
  • Actual Study Start Date: November 2018
  • Estimated Primary Completion Date: March 2022
  • Estimated Study Completion Date: June 2022
Outcome Measures
  • 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 ]
    Usage patterns including the treatment line, dose, frequency of dose, duration, and polytherapy regimens.
  • 2. Proportion 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 ]
    Sources of infection including community-acquired infection (CAI), hospital-acquired infection (HAI) and healthcare-associated infection (HCAI).
  • 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 ]
    Treatment Success, Length of Stay in Hospital, In-Hospital mortality 30-60 day post discharge, and Hospital Re-Admissions.
  • 2. Proportion of patients and their respective safety outcomes of treatment with ceftazidime-avibactam [ Time Frame: Drug initiation until 60 days post-hospital discharge ]
    Treatment Success, Length of Stay in Hospital, In-Hospital mortality 30-60 day post discharge, and Hospital Re-Admissions.
Eligibility Criteria
  • 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.

Contacts and Locations
Contacts

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

Locations
Show 15 Study Locations
Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center Pfizer

More Information
  • Responsible Party: Pfizer
  • ClinicalTrials.gov Identifier: NCT03923426 History of Changes
  • Other Study ID Numbers: C3591031, EZTEAM STUDY
  • First Posted: April 22, 2019 Key Record Dates
  • Last Update Posted: August 12, 2020
  • Last Verified: August 2020
  • 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