Real-World Observational Study Of Zavicefta to Characterize Use Patterns

Launched by PFIZER · Apr 18, 2019

Keywords

ClinConnect Summary

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 pat...

Gender

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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.