Real-World Observational Study Of Zavicefta to Characterize Use Patterns
NCT03923426
ABOUT THIS STUDY
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Adult Trials: 18+ Years
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.
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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| 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 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. | ||||
| Detailed Description | Not Provided | ||||
| 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 | 1030 | ||||
| Original Estimated Enrollment | 630 | ||||
| Estimated Study Completion Date | March 1, 2022 | ||||
| Estimated Primary Completion Date | March 1, 2022 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria: Patients must not meet any of the following exclusion criteria to be eligible:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
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| Listed Location Countries | France | ||||
| 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 |
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| Responsible Party | Pfizer | ||||
| Study Sponsor | Pfizer | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Pfizer | ||||
| Verification Date | February 2020 | ||||