Real-World Study of Ceftazidime Avibactam in China

Hospital Acquired Pneumonia Clinical Trial

— REACT  

Official title:

Real-World Study of Ceftazidime-Avibactam to Characterize the Usage in Clinical Practice

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05487586
• Other study ID #: C3591037
• Status: Recruiting
• Start date: October 20, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: November 2023
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Complicated Intra Abdominal Infections
• Healthcare-Associated Pneumonia
• Hospital Acquired Pneumonia
• Intraabdominal Infections
• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Acquired Pneumonia

Intervention

Drug:
• ceftazidime avibactam group
Non-Interventional Study

Locations

Country	Name	City	State
China	Beijing Tsinghua Changgung Hospital	Beijing
China	Xiangya Hospital Central South University	Changsha
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou
China	Sir Run Run Shaw Hospital, Zhejiang University School of Medicine	Hangzhou
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou
China	The First affiliated Hospital of Anhui Medical University	Hefei
China	The First Affiliated Hospital of Nanchang University	Nanchang
China	Zhongda Hospital Southeast University	Nanjing
China	The Affiliated People's Hospital of Ningbo University	Ningbo
China	Huashan Hospital Fudan University	Shanghai	Shanghai
China	Shanghai Tenth People's Hospital	Shanghai
China	The Second People's Hospital of Hebei Medical University	Shijiazhuang
China	The Third Hospital of Hebei Medical University	Shijiazhuang
China	The First Affiliated Hospital of Soochow University	Suzhou
China	Tianjin Medical University General Hospital	Tianjing
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xian
China	Henan Provincial People's Hospital	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical success rate after ceftazidime-avibactam treatment initiation		Up to 1 year
Primary	Microbiologic success rate after ceftazidime-avibactam treatment initiation		Up to 1 year
Primary	Percentage of patients by demographic characteristics		Day 1
Primary	Percentage of patients by indication type		Day 1
Primary	Percentage of patients by source of infection		Day 1
Primary	Percentage of isolated strains		Day 1
Primary	Susceptibility of ceftazidime-avibactam		Day 1
Primary	The percentage of carbapenem-resistant organisms		Day 1
Primary	Percentage of Genotype		Day 1
Secondary	The percentage of patients treated in different dose and frequency of ceftazidime-avibactam		Up to 1 year
Secondary	The percentage of patients receiving combination therapy with ceftazidime-avibactam.		Up to 1 year
Secondary	The percentage of patients in each combination therapy with ceftazidime-avibactam.		Up to 1 year
Secondary	Duration in days of exposure to ceftazidime-avibactam		Up to 1 year
Secondary	Length of Stay (LOS)		Up to 1 year
Secondary	Length of Stay in ICU (LOS-ICU)		Up to 1 year
Secondary	The percentage of patients by different admission diagnosis		Up to 1 year
Secondary	The percentage of patients with invasive procedures, source of infection management, dialysis and/or surgery		Up to 1 year
Secondary	Length of mechanical ventilation		Up to 1 year
Secondary	The number and percentage of patients by different discharge diagnosis		Up to 1 year
Secondary	The percentage of patients with any re-admission due to recurrence of infection happened in the same location within 30 and 60 days after discharge.		Up to 1 year
Secondary	The percentage of patients treated by ceftazidime-avibactam that died during hospitalization.		Up to 1 year

External Links

•   To obtain contact information for a study center near you, click here.