Efficacy and Safety of Ceftazidime-Avibactam (CAZ-AVI) in Chinese Participants With HAP (Including VAP)

August 29, 2023 updated by: Pfizer

A SINGLE ARM, OPEN-LABEL, MULTI-CENTER, INTERVENTIONAL STUDY EVALUATING THE EFFICACY AND SAFETY OF CEFTAZIDIME-AVIBACTAM (CAZ-AVI) IN CHINESE ADULTS WITH HAP (INCLUDING VAP)

This is a prospective, single arm, open-label, multi-center clinical study evaluating the effectiveness and safety of CAZ-AVI in participants with HAP (including VAP), who have initiated treatment with CAZ-AVI in an inpatient hospital setting. The duration of antibiotic treatment with the CAZ-AVI is 7-14 days. Participants must receive intravenously (IV) CAZ-AVI in the hospital for at least 7 full days. There are no formal hypothesis tests planned for this study. The number and percent of participants having clinical cure, failure, and indeterminate at TOC visit in the cMITT analysis population will be summarized.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
235

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Seventh Medical Center, The General Hospital of People's Liberation Army
      • Shanghai, China, 200240
        • Shanghai Fifth People's Hospital, Fudan University
      • Xiamen, China
        • Zhongshan Hospital Xiamen University
    • Anhui
      • Fuyang, Anhui, China, 236000
        • Fuyang People's Hospital
    • Beijing
      • Beijing, Beijing, China, 100191
        • Peking University Third Hospital
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • The First Affiliated Hospital of Fujian Medical University
      • Xiamen, Fujian, China, 361004
        • Zhongshan Hospital Xiamen University
    • Guangdong
      • Guangzhou, Guangdong, China, 510180
        • Guangzhou First People's Hospital
      • Guangzhou, Guangdong, China, 510630
        • The First Affiliated Hospital of Jinan University
      • Guangzhou, Guangdong, China, 510280
        • ZhuJiang Hospital of Southern Medical University
      • Huizhou, Guangdong, China, 516008
        • Huizhou Central People's Hospital
      • Qingyuan, Guangdong, China, 511500
        • Qingyuan People's Hospital
      • Shenzhen, Guangdong, China, 518020
        • Shenzhen People's Hospital
      • Shenzhen, Guangdong, China, 518035
        • The Second People's Hospital of Shenzhen
      • Zhanjiang, Guangdong, China, 524000
        • Affiliated Hospital of Guangdong Medical University
      • Zhanjiang, Guangdong, China, 524045
        • Central People's Hospital of Zhanjiang
    • Guangxi Zhuang Autonomous Region
      • Nanning, Guangxi Zhuang Autonomous Region, China, 530022
        • The First People's Hospital of Nanning
    • Guizhou
      • Zunyi, Guizhou, China, 563000
        • The Affiliated Hospital of Zunyi Medical University
    • Hainan
      • Haikou, Hainan, China, 570311
        • Hainan General Hospital
      • Sanya, Hainan, China, 572022
        • Sanya People's Hospital
    • Hebei
      • Baoding, Hebei, China, 071000
        • Affiliated Hospital of Hebei University
    • Henan
      • Luoyang, Henan, China, 471009
        • Luoyang Central Hospital
      • Nanyang, Henan, China, 473000
        • Nanyang Central Hospital
      • Nanyang, Henan, China, 47300
        • Nanyang First People's Hospital
      • Zhengzhou, Henan, China, 450003
        • Henan Provincial People's Hospital
    • Hubei
      • Shiyan, Hubei, China, 442000
        • Shiyan Renmin Hospital
      • Wuhan, Hubei, China, 430060
        • Renmin Hospital of Wuhan University
      • Wuhan, Hubei, China, 430058
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    • Hunan
      • Changsha, Hunan, China, 410005
        • Hunan Provincial People's Hospital
      • Yueyang, Hunan, China, 414020
        • Yueyang People's Hospital
    • Inner Mongolia Autonomous Region
      • Baotou, Inner Mongolia Autonomous Region, China, 014040
        • Baotou Central Hospital
      • Baotou, Inner Mongolia Autonomous Region, China, 014000
        • Baotou Central Hospital
    • Jiangsu
      • Huai'an, Jiangsu, China, 223300
        • Huai'an first people's hospital
      • Jiangyin, Jiangsu, China, 214400
        • Jiangyin People's Hospital
      • Lianyungang, Jiangsu, China, 222002
        • The First People's Hospital of Lianyungang City
      • Taizhou, Jiangsu, China, 225300
        • Taizhou People's Hospital
      • Wuxi, Jiangsu, China, 214122
        • Affiliated Hospital of Jiangnan University
      • Xuzhou, Jiangsu, China, 221002
        • The Affiliated Hospital of Xuzhou Medical University
      • Yangzhou, Jiangsu, China, 225001
        • Subei People's Hospital of Jiangsu province
    • Jiangxi
      • Nanchang, Jiangxi, China, 330038
        • Jiangxi Provincial People's Hospital
    • Liaoning
      • Dalian, Liaoning, China, 116001
        • Affiliated Zhongshan Hospital of Dalian University
      • Shenyang, Liaoning, China, 110016
        • General Hospital of Northern Theater Command
    • Ningxia
      • Yinchuan, Ningxia, China, 750004
        • General Hospital of Ningxia Medical University
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Huashan Hospital Fudan University
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital of Sichuan University
      • Chengdu, Sichuan, China, 610055
        • Chengdu Xinhua Hospital
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Tianjin Medical University General Hospital
      • Tianjin, Tianjin, China, 300222
        • Tianjin Chest Hospital
    • Yunnan
      • Kunming, Yunnan, China, 650034
        • The First Hospital of Kunming
    • Zhejiang
      • Dongyang, Zhejiang, China, 322199
        • Dongyang People's Hospital
      • Hangzhou, Zhejiang, China, 310014
        • Zhejiang Provincial People's Hospital
      • Hangzhou, Zhejiang, China, 310030
        • Zhejiang Hospital
      • Hangzhou, Zhejiang, China, 310013
        • Zhejiang Hospital
      • Hangzhou, Zhejiang, China, 310016
        • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
      • Wenzhou, Zhejiang, China, 325035
        • The 2nd Affiliated Hospital of WMU
      • Wenzhou, Zhejiang, China, 325099
        • Wenzhou Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female participants ≥18 and ≤90 years of age.
  • Onset of symptoms ≥48 hours after admission or <7 days after discharge from an inpatient acute or chronic care facility.
  • New or worsening infiltrate on chest X-ray obtained within 48 hours prior to screening.
  • Participants have systemic signs and respiratory signs or symptoms of HAP/VAP

Exclusion Criteria:

  • Other medical or psychiatric condition may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  • Participant is expected to require a treatment course for HAP longer than 14 days.
  • The total duration of antibiotic exposure for antibiotics whose administration begins in the 48 hours is longer than 24 hours.
  • Previous administration with an investigational drug within 30 days or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
  • Acute Physiology and Chronic Health Evaluation (APACHE) II score >30 or <10 using the most recent available data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CAZ-AVI
Drug: Zavicefta, Ceftazidime-Avibactam
Participants will receive CAZ-AVI (2000 mg of ceftazidime and 500 mg of avibactam) administered by IV infusion in a volume of 100 mL at a constant rate over 2 hours.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The number of HAP participants having clinical cure
Time Frame: Test of Cure(TOC, Day 21 - 25)
Test of Cure(TOC, Day 21 - 25)
The percentage of HAP participants having clinical cure
Time Frame: Test of Cure(TOC, Day 21 - 25)
Test of Cure(TOC, Day 21 - 25)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The number of HAP participants having clinical cure
Time Frame: End of Treatment(EOT, participants were followed after the last IV dose but no later than 24 hours after the last IV dose)
End of Treatment(EOT, participants were followed after the last IV dose but no later than 24 hours after the last IV dose)
The number of HAP participants having microbiological favorable response (per-patient and per-pathogen)
Time Frame: Test of Cure(TOC, Day 21-Day 25)
Test of Cure(TOC, Day 21-Day 25)
The number of HAP participants with death
Time Frame: Day 28 after enrollment
Day 28 after enrollment
The percentage of HAP participants having clinical cure
Time Frame: End of Treatment(EOT, participants were followed after the last IV dose but no later than 24 hours after the last IV dose)
End of Treatment(EOT, participants were followed after the last IV dose but no later than 24 hours after the last IV dose)
The percentage of HAP participants having microbiological favorable response (per-patient and per-pathogen)
Time Frame: Test of Cure(TOC, Day 21-Day 25)
Test of Cure(TOC, Day 21-Day 25)
The percentage of HAP participants having microbiological favorable response (per-patient and per-pathogen)
Time Frame: End of Treatment(EOT, participants were followed after the last IV dose but no later than 24 hours after the last IV dose)
End of Treatment(EOT, participants were followed after the last IV dose but no later than 24 hours after the last IV dose)
The number of HAP participants having microbiological favorable response (per-patient and per-pathogen)
Time Frame: End of Treatment(EOT, participants were followed after the last IV dose but no later than 24 hours after the last IV dose)
End of Treatment(EOT, participants were followed after the last IV dose but no later than 24 hours after the last IV dose)
The percentage of HAP participants with death
Time Frame: Day 28 after enrollment
Day 28 after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 21, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 4, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 4, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 1, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C3591026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings