Real-World Study of Ceftazidime Avibactam in China

NCT05487586 | Terminated Results FDA Drug

• 1 other identifier: C3591037
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 17

Brief 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.

Conditions

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

Keywords

hospital acquired pneumonia; ventilator acquired pneumonia; complicated intra abdominal infections; ceftazidime avibactam; carbapenem-resistant Enterobacteriaceae

Outcome Measures

Primary Outcomes (35)

• Clinical Success Rate at Day 7

  The clinical success rate was defined as the number of participants with clinical outcome as "success" in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method.

  Day 7 (from the data evaluated in approximately 21 months of the study)

• Clinical Success Rate at Day 14

  The clinical success rate was defined as the number of participants with clinical outcome as "success" in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method.

  Day 14 (from the data evaluated in approximately 21 months of the study)

• Clinical Success Rate at Day 21

  The clinical success rate was defined as the number of participants with clinical outcome as "success" in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method.

  Day 21 (from the data evaluated in approximately 21 months of the study)

• Clinical Success Rate at Day 30

  The clinical success rate was defined as the number of participants with clinical outcome as "success" in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method.

  Day 30 (from the data evaluated in approximately 21 months of the study)

• Clinical Success Rate at Day 60

  The clinical success rate was defined as the number of participants with clinical outcome as "success" in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method.

  Day 60 (from the data evaluated in approximately 21 months of the study)

• Clinical Success Rate at End of Treatment (EOT)

  The clinical success rate was defined as the number of participants with clinical outcome as "success" in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method.

  At EOT (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)

• Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 7

  The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (gram positive/fungi) (colonization). 95% CI was based on Clopper-Pearson method.

  Day 7 (from the data evaluated in approximately 21 months of the study)

• Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 14

  The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.

  Day 14 (from the data evaluated in approximately 21 months of the study)

• Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 21

  The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.

  Day 21 (from the data evaluated in approximately 21 months of the study)

• Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 30

  The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.

  Day 30 (from the data evaluated in approximately 21 months of the study)

• Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 60

  The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.

  Day 60 (from the data evaluated in approximately 21 months of the study)

• Microbiological Success Rate Based on the Evaluation by Site Investigator at EOT

  The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.

  At EOT (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)

• Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 7

  The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.

  Day 7 (from the data evaluated in approximately 21 months of the study)

• Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 14

  The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.

  Day 14 (from the data evaluated in approximately 21 months of the study)

• Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 21

  The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.

  Day 21 (from the data evaluated in approximately 21 months of the study)

• Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 30

  The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.

  Day 30 (from the data evaluated in approximately 21 months of the study)

• Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 60

  The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.

  Day 60 (from the data evaluated in approximately 21 months of the study)

• Microbiological Success Rate Based on the Evaluation by Central Laboratory at EOT

  The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.

  At EOT (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)

• Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 7

  The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.

  Day 7 (from the data evaluated in approximately 21 months of the study)

• Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 14

  The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.

  Day 14 (from the data evaluated in approximately 21 months of the study)

• Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 21

  The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.

  Day 21 (from the data evaluated in approximately 21 months of the study)

• Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 30

  The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.

  Day 30 (from the data evaluated in approximately 21 months of the study)

• Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 60

  The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.

  Day 60 (from the data evaluated in approximately 21 months of the study)

• Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at EOT

  The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.

  At EOT (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)

• Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 7

  The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.

  Day 7 (from the data evaluated in approximately 21 months of the study)

• Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 14

  The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.

  Day 14 (from the data evaluated in approximately 21 months of the study)

• Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 21

  The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.

  Day 21 (from the data evaluated in approximately 21 months of the study)

• Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 30

  The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.

  Day 30 (from the data evaluated in approximately 21 months of the study)

• Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 60

  The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.

  Day 60 (from the data evaluated in approximately 21 months of the study)

• Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at EOT

  The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.

  At EOT (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)

• Number of Participants According to Indication for Ceftazidime-Avibactam at Index Date

  Index date was defined as the date when participants initiated \>=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligibility criteria.

  At index date (from the data evaluated in approximately 21 months of the study)

• Number of Participants According to Source of Infection

  Index date was defined as the date when participants initiated \>=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligibility criteria.

  At index date (from the data evaluated in approximately 21 months of the study)

• Number of Isolated Strains

  The index date was defined as the date when participants initiated \>=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria.

  At baseline (from 7 days prior to index date until index date) (from the data evaluated in approximately 21 months of the study)

• Number of Strains With Resistance to Ceftazidime-Avibactam and Other Antibiotic Drugs

  The index date was defined as the date when participants initiated \>=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participant's first hospitalization met the eligible criteria. Number of strains with resistance to ceftazidime-avibactam and other antibiotic drugs is reported. One strain could be resistant to more than one antibiotic.

  At baseline (from 7 days prior to index date until index date) (from the data evaluated in approximately 21 months of the study)

• Number of Carbapenem-Resistant Strains

  The index date was defined as the date when participants initiated \>=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria.

  At baseline (from 7 days prior to index date until index date) (from the data evaluated in approximately 21 months of the study)

Secondary Outcomes (22)

• Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Full Analysis Set

  From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)

• Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Clinically Evaluable Analysis Set

  From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)

• Duration of Exposure to Ceftazidime-Avibactam: Full Analysis Set

  From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)

• Duration of Exposure to Ceftazidime-Avibactam: Clinically Evaluable Analysis Set

  From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)

• Number of Participants Who Received Combination Therapy With Ceftazidime-Avibactam: Full Analysis Set

  From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)

Study Arms (1)

ceftazidime avibactam group

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

Drug: ceftazidime avibactam group

Interventions

ceftazidime avibactam group DRUG

Non-Interventional Study

Also known as: CAZ/AVI group

ceftazidime avibactam group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients treated with CAZ AVI for ≥1 dose in approximately 20 study sites.

You may qualify if:

• Initiate ≥1 dose of ceftazidime-avibactam during hospitalization.
• Aged ≥ 18 years old at the time of the informed consent signature.

You may not qualify if:

• Are enrolled in any clinical trial, including enrollment in non interventional studies.
• Pregnant women.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (17)

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Beijing Tsinghua Changgung Hospital

Beijing, China

Location

Xiangya Hospital Central South University

Changsha, China

Location

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, China

Location

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, China

Location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, China

Location

The First affiliated Hospital of Anhui Medical University

Hefei, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, China

Location

Zhongda Hospital Southeast University

Nanjing, China

Location

The Affiliated People's Hospital of Ningbo University

Ningbo, China

Location

Shanghai Tenth People's Hospital

Shanghai, China

Location

The Second People's Hospital of Hebei Medical University

Shijiazhuang, China

Location

The Third Hospital of Hebei Medical University

Shijiazhuang, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, China

Location

Tianjin Medical University General Hospital

Tianjing, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

Location

Henan Provincial People's Hospital

Zhengzhou, China

Location

Related Links

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

MeSH Terms

Conditions

Healthcare-Associated Pneumonia; Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: August 4, 2022
• Study Start: October 20, 2022
• Primary Completion: July 11, 2024
• Study Completion: July 11, 2024
• Last Updated: September 4, 2025
• Results First Posted: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (17)