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Real-World Observational Study Of Zavicefta to Characterize Use Patterns

Last updated on June 6, 2019

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Study Location
CHU Angers - Hôpital Hôtel Dieu
Angers, , 49100 France
Contact
1-800-718-1021
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.
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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.
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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.

NCT03923426
Pfizer
Recruiting
Real-World Observational Study Of Zavicefta to Characterize Use Patterns

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