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Real-World Observational Study Of Zavicefta to Characterize Use Patterns
Real-World Observational Study Of Zavicefta to Characterize Use Patterns

NCT03923426

CompletedN/A

Sponsor: Pfizer

Conditions: Infection

Interventions: Zavicefta Treatment

Countries: Argentina, Austria, Brazil, Colombia, France, Germany, Greece, Italy

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

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.
Locations (45)
  • Buenos Aires, Argentina
  • CABA, Argentina
  • Ciudad Autonoma Buenos Aires, Argentina
  • Ciudad Autonoma Buenos Aires, Argentina
  • Córdoba, Argentina
  • Rosario, Argentina
  • Vienna, Austria
  • Belo Horizonte, Brazil
  • Belo Horizonte, Brazil
  • Curitiba, Brazil
  • Porto Alegre, Brazil
  • Santa Maria, Brazil
  • Cali, Colombia
  • Manizales, Colombia
  • Medellín, Colombia
  • Medellín, Colombia
  • Angers, France
  • Nantes, France
  • Paris, France
  • Paris, France
  • Tourcoing, France
  • Frankfurt, Germany
  • Jena, Germany
  • Pátrai, Achaia, Greece
  • Athens, Attica, Greece
  • Rome, ROMA, Italy
  • Bologna, Italy
  • Genoa, Italy
  • Pisa, Italy
  • Torino, Italy
  • + 15 more on CT.gov