Real-World Observational Study Of Zavicefta to Characterize Use Patterns

NCT03923426

Last updated date
Study Location
University Hospital Jena
Jena, , 07747, Germany
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
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. 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

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Advanced Information
Descriptive Information
Brief Title Real-World Observational Study Of Zavicefta to Characterize Use Patterns
Official Title Real-World Observational Study of Zavicefta (Registered) (Ceftazidime-avibactam) to Characterize Use Patterns, Effectiveness and Safety - EZTEAM Study
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.
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Infection
Intervention Other: Zavicefta Treatment
Non-interventional - Retrospective Chart Review
Study Groups/Cohorts Not Provided
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 Recruiting
Estimated Enrollment
 (submitted: July 22, 2020)
700
Original Estimated Enrollment
 (submitted: April 18, 2019)
630
Estimated Study Completion Date June 30, 2022
Estimated Primary Completion Date March 1, 2022   (Final data collection date for primary outcome measure)
Eligibility 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.
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 Center1-800-718-1021[email protected]
Listed Location Countries Austria,   France,   Germany,   Italy,   Russian Federation,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03923426
Other Study ID Numbers C3591031
EZTEAM STUDY ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
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/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2020