EZTEAM: Real-World Observational Study Of Zavicefta to Characterize Use Patterns
Study Details
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 | Intervention/Treatment | Phase |
|---|---|---|
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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
Outcome Measures
Primary Outcome Measures
- Proportion of patients for each indication and reason for use of ceftazidime-avibactam [Drug initiation until 60 days post-hospital discharge]
Usage patterns including the treatment line, dose, frequency of dose, duration, and polytherapy regimens.
- Proportion of patients for each usage pattern of ceftazidime-avibactam. [Drug initiation until 60 days post-hospital discharge]
Usage patterns including treatment line, dose, frequency of dose, duration, and polytherapy regimens.
- Proportion of patients treated with ceftazidime-avibactam with defined microbiologic evidence of infection. [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).
- Proportion of patients treated with ceftazidime-avibactam with a defined source of infection. [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
- Proportion of patients and their respective clinical outcomes of treatment with ceftazidime-avibactam [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.
- Proportion of patients and their respective safety outcomes of treatment with ceftazidime-avibactam [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
Criteria
Inclusion Criteria:
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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.
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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.
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Patient underwent microbiologic sampling ≤5 days before the initiation of ceftazidime-avibactam (irrespective of results and actual bacteriological identification).
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Patient has all required essential data elements which include:
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Start and stop dates of ceftazidime-avibactam,
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Start and stop dates of prior antibiotic therapy used for the index infection,
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Type of combined antibiotic therapy (if applicable) and start and stop dates of any antibiotic combined with ceftazidime-avibactam.
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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:
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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.
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The patient has received ceftazidime-avibactam in a compassionate care program setting.
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The patient was exposed to ceftazidime-avibactam before use for the index infection.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | AKH - Medizinische Universität Wien | Vienna | Austria | 1090 | |
| 2 | CHU Angers - Hôpital Hôtel Dieu | Angers | France | 49100 | |
| 3 | University Hospital Jena | Jena | Germany | 07747 | |
| 4 | Policlinico Universitario Agostino Gemelli | Rome | Roma | Italy | 00168 |
| 5 | Regional Clinical Hospital #1 | Krasnodar | Russian Federation | 350000 | |
| 6 | SBIH of Moscow City Clinical Hospital # 7 | Moscow | Russian Federation | 115446 | |
| 7 | FSBI "State Scientific Centre of Coloproctology" of the MoH of RF | Moscow | Russian Federation | 123154 | |
| 8 | FSBI "Hematological Research Center" MoH of RF | Moscow | Russian Federation | 125167 | |
| 9 | North-West Federal Medical Research Center n.a. V.A. Almazov | Saint-Petersburg | Russian Federation | 197341 | |
| 10 | SBIH Republican Clinical Hospital n.a. G. G. Kuvatov | Ufa | Russian Federation | 450000 | |
| 11 | Complexo Hospitalario Universitario de Vigo | Vigo | Pontevedra | Spain | 36312 |
| 12 | Hospital Universitari Vall d'Hebron | Barcelona | Spain | 08035 | |
| 13 | Hospital Universitari de Bellvitge | Barcelona | Spain | 08207 | |
| 14 | Hospital Universitario Reina Sofía | Córdoba | Spain | 14004 | |
| 15 | Hopsital Ramón y Cajal | Madrid | Spain | 28034 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- C3591031
- EZTEAM STUDY