Real-World Study of Ceftazidime Avibactam in China (REACT)

Pfizer

Status: Terminated

Conditions: Hospital Acquired Pneumonia; Ventilator Acquired Pneumonia; Complicated Intra Abdominal Infections

Treatments: Drug: ceftazidime avibactam group

Study type: Observational

Funder types: Industry

Identifiers

NCT05487586

C3591037

Details and patient eligibility

About

This observational study will enroll approximately 450 in patients. Patients treated with CAZ AVI for at least 1 dose at around 20 research centers in China will be enroll.

Full description

The recruitment will last for approximately 6 months or until recruitment target is met, and information about treatment will be collected from the patients' medical records. Patients will be followed from CAZ AVI initiation until death, withdraw of the study, 60 days after discharged from the hospitalization, whichever comes first. The endpoint events will be evaluated at: 7 days, 14 days, 21 days, 30 days, 60 days, and end of treatment (EOT) after CAZ AVI initiation, if patients are not discharged prior to the next upcoming timepoint; and 30 days, 60 days after discharge.

Enrollment: 220 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria：

• Initiate ≥1 dose of ceftazidime-avibactam during hospitalization.
• Aged ≥ 18 years old at the time of the informed consent signature.
• Provide signed informed consent. Exclusion criteria：
• Are enrolled in any clinical trial, including enrollment in non interventional studies.
• Pregnant women.

Trial design

220 participants in 1 patient group

ceftazidime avibactam group

Description:

Receive ≥1 dose of ceftazidime avibactam in routine practice; Aged ≥ 18 years old at the time of the informed consent signature.

Treatment:

Drug: ceftazidime avibactam group