Hospital-Acquired PneumoniaPhase 4NCT04774094
Efficacy and Safety of Ceftazidime-Avibactam (CAZ-AVI) in Chinese Participants With HAP (Including VAP)
A Phase 4 study testing Zavicefta, Ceftazidime-Avibactam in people with Hospital-Acquired Pneumonia, run by Pfizer at 56 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hospital-Acquired Pneumonia
- What is being tested?
- Zavicefta, Ceftazidime-Avibactam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 56 sitesChina
- Study dates
- 21 May 2021to 4 May 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
56 sites in 1 country.
56 sites in 1 country
China56 sites
Affiliated Hospital of Hebei University
Baoding, Hebei, 071000
Baotou Central Hospital
Baotou, Inner Mongolia, 014000
Baotou Central Hospital
Baotou, Inner Mongolia, 014040
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Seventh Medical Center, The General Hospital of People's Liberation Army
Beijing
Hunan Provincial People's Hospital
Changsha, Hunan, 410005
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Chengdu Xinhua Hospital
Chengdu, Sichuan, 610055
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, 116001
Dongyang People's Hospital
Dongyang, Zhejiang, 322199
Fuyang People's Hospital
Fuyang, Anhui, 236000
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180
ZhuJiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 510630
Hainan General Hospital
Haikou, Hainan, 570311
Zhejiang Hospital
Hangzhou, Zhejiang, 310013
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310016
Zhejiang Hospital
Hangzhou, Zhejiang, 310030
Huai'an First People's Hospital
Huai'an, Jiangsu, 223300
Huizhou Central People's Hospital
Huizhou, Guangdong, 516008
Jiangyin People's Hospital
Jiangyin, Jiangsu, 214400
The First Hospital of Kunming
Kunming, Yunnan, 650034
The First People's Hospital of Lianyungang City
Lianyungang, Jiangsu, 222002
Luoyang Central Hospital
Luoyang, Henan, 471009
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330038
The First People's Hospital of Nanning
Nanning, Guangxi, 530022
NanYang central hospital
Nanyang, Henan, 473000
NanYang First people's hospital
Nanyang, Henan, 47300
Qingyuan People's Hospital
Qingyuan, Guangdong, 511500
Sanya People's Hospital
Sanya, Hainan, 572022
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200040
Shanghai Fifth People's Hospital, Fudan University
Shanghai, 200240
General Hospital of Northern Theater Command
Shenyang, Liaoning, 110016
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020
The Second People's Hospital of Shenzhen
Shenzhen, Guangdong, 518035
Shiyan Renmin Hospital
Shiyan, Hubei, 442000
Taizhou People's Hospital
Taizhou, Jiangsu, 225300
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300222
The 2nd Affiliated Hospital of WMU
Wenzhou, Zhejiang, 325035
Wenzhou Central Hospital
Wenzhou, Zhejiang, 325099
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430058
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, 214122
Zhongshan Hospital Xiamen University
Xiamen, Fujian, 361004
Zhongshan Hospital Xiamen University
Xiamen
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221002
Subei People's Hospital of Jiangsu province
Yangzhou, Jiangsu, 225001
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
Yueyang People's Hospital
Yueyang, Hunan, 414020
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, 524000
Central People's Hospital of Zhanjiang
Zhanjiang, Guangdong, 524045
Henan provincial people's hospital
Zhengzhou, Henan, 450003
The Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563000
About this study
Official title: 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.
- Conditions
- Hospital-Acquired Pneumonia
- Being tested
- Zavicefta, Ceftazidime-Avibactam
- Medical subject headings
- Healthcare-Associated Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zavicefta, Ceftazidime-AvibactamDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| CAZ-AVI | Experimental | Not described Receives: Drug: Zavicefta, Ceftazidime-Avibactam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Clinical Cure at Test of Cure (TOC) Visit: Clinical Modified Intent-to-Treat (cMITT) Population
Clinical cure: participants were considered to be a success for clinical response at TOC visit if the participants were not a clinical failure at end of treatment (EOT), and the participants were alive and all signs and symptoms of pneumonia were resolved or improved to an extent that no antibacterial therapy for HAP was taken between EOT and TOC inclusive. Gram negative is abbreviated as gram -ve and gram positive as gram +ve.
Measured: TOC visit: any day from Day 21 to 25
Secondary outcomes (11)
Percentage of Participants With Clinical Cure at EOT Visit: cMITT Population
Clinical cure: participants were considered to be a success for clinical response at EOT visit if the participants were alive and all signs and symptoms of pneumonia were resolved or improved such that all antibacterial therapies for HAP/ VAP were stopped. No antibacterial therapy other than those outlined by the protocol was administered for HAP prior to EOT.
Measured: EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days)
Percentage of Participants With Clinical Cure at EOT and TOC Visit: Microbiological Modified Intent-to-Treat (mMITT) Population
Clinical cure at EOT: participants were considered to be a success for clinical response at EOT visit if the participants were alive and all signs and symptoms of pneumonia were resolved or improved such that all antibacterial therapies for HAP/VAP were stopped. No antibacterial therapy other than those outlined by the protocol was administered for HAP prior to EOT. Clinical cure at TOC: participants were considered to be a success for clinical response at TOC visit if the participants were not a clinical failure at EOT, and the participants were alive and all signs and symptoms of pneumonia were resolved or improved to an extent that no antibacterial therapy for HAP was taken between EOT and TOC inclusive.
Measured: EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25
Percentage of Participants With Favorable Per-Participant Microbiological Response at the EOT and TOC Visits: mMITT Population
For participants from whom only 1 causative pathogen is isolated, the overall microbiological response assessment was based on the microbiological response assessment for that pathogen. For participants from whom more than 1 baseline pathogen was isolated, the overall microbiological response assessment was "favorable" only if the microbiological response assessment for each of the baseline pathogens isolated was "favorable". Favorable microbiological response included eradication (an adequate source specimen demonstrated absence of the original baseline pathogen) and presumed eradication (an adequate source specimen was not available to culture and the participant was assessed as a clinical cure). In this outcome measure percentage of participants with favorable per-participant microbiological response are recorded.
Measured: EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25
Percentage of Participants With Favorable Per-Pathogen Microbiological Response at the EOT and TOC Visits: mMITT Population
Favorable microbiological response included eradication (an adequate source specimen demonstrated absence of the original baseline pathogen) and presumed eradication (an adequate source specimen was not available to culture and the participant was assessed as a clinical cure). In this outcome measure percentage of participants with favorable per-pathogen microbiological response are recorded.
Measured: EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25
Percentage of Participants With Clinical Cure at the EOT and TOC Visits in Participants With Gram-negative Baseline Pathogens Resistant to Ceftazidime: mMITT Population
Clinical cure at EOT: participants were considered to be a success for clinical response at EOT visit if the participants were alive and all signs and symptoms of pneumonia were resolved or improved such that all antibacterial therapies for HAP/VAP were stopped. No antibacterial therapy other than those outlined by the protocol was administered for HAP prior to EOT. Clinical cure at TOC: participants were considered to be a success for clinical response at TOC visit if the participants were not a clinical failure at EOT, and the participants were alive and all signs and symptoms of pneumonia were resolved or improved to an extent that no antibacterial therapy for HAP was taken between EOT and TOC inclusive.
Measured: EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25
Percentage of Participants With Favorable Per-Participant Microbiologic Response at the EOT and TOC Visits in Participants With Gram-negative Baseline Pathogens Resistant to Ceftazidime: mMITT Population
For participants from whom only 1 causative pathogen is isolated, the overall microbiological response assessment was based on the microbiological response assessment for that pathogen. For participants from whom more than 1 baseline pathogen was isolated, the overall microbiological response assessment was "favorable" only if the microbiological response assessment for each of the baseline pathogens isolated was "favorable". Favorable microbiological response included eradication (an adequate source specimen demonstrated absence of the original baseline pathogen) and presumed eradication (an adequate source specimen was not available to culture and the participant was assessed as a clinical cure). In this outcome measure percentage of participants with favorable per-participant microbiological response are recorded.
Measured: EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25
Percentage of Participants With Death Due to Any Cause at the TOC Visit and at Day 28 Visit: cMITT Population
Measured: TOC visit: any day from Day 21 to 25; Day 28
Percentage of Participants With Death Due to Any Cause at the TOC Visit and at Day 28 Visit: mMITT Population
Measured: TOC visit: any day from Day 21 to 25; Day 28
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and all non-SAEs that occurred in the study. TEAEs were AEs between first dose of study treatment and up to 32 days post last dose that were absent before treatment or that worsened relative to pretreatment state.
Measured: Day 1 up to 32 days after last dose of CAZ-AVI (maximum up to 46 days; maximum treatment duration was of 14 days)
Number of Participants With Clinically Significant Post-Baseline Laboratory Test Abnormalities
Hematology: Hemoglobin (Hg), hematocrit, erythrocytes: less than (<)0.8*lower limit of normal (LLN) \& change (chg) more than (>)20% decrease (dec); platelets: <0.65*LLN \& chg >50% dec \&, >1.5* upper limit of normal (ULN) \& chg >100% increase (inc); leukocytes: <0.65*LLN \& chg >60% dec \&, >1.6*ULN \& chg >100% inc; lymphocytes, <0.25*LLN \& chg >75% dec; neutrophils: <0.65*LLN \& chg >75% dec \&, >1.6*ULN \& chg >100% inc; basophils, monocytes: >4.0* ULN \& chg >300% inc. Clinical chemistry: bilirubin: >2.0*ULN \& chg >150% inc; aspartate aminotransferase (AT) \& Alanine AT: >3.0*ULN \& chg >200% inc; alkaline phosphatase <0.5*LLN \& chg >80% dec \& >2.0*ULN \& chg >100% inc; creatinine: >2.0*ULN \& >chg 100% inc; sodium: <0.85*LLN \& chg >10% dec \& >1.1*ULN \& chg >10% inc; potassium \& chloride: <0.8*LLN \& chg >20% dec \& >1.2*ULN \& chg >20% dec; calcium: <0.7*LLN \& chg >30% dec \& bicarbonate: <0.7*LLN \& chg >40% dec. Clinical significance was judged by investigator.
Measured: Day 1 up to 32 days after last dose of CAZ-AVI (maximum up to 46 days; maximum treatment duration was of 14 days)
Number of Participants With Vital Signs Data According to Pre-defined Criteria
Vital signs included diastolic blood pressure (millimeters of mercury [mmHg]); pulse rate (beats per minute [bpm]) and systolic blood pressure (mmHg). Pre-defined criteria: Diastolic blood pressure: Value <50 mmHg, Diastolic blood pressure: Change more than or equal to (>=) 20 mmHg increase, Diastolic blood pressure: Change >= 20 mmHg decrease, Pulse rate: Value <40 bpm, Pulse rate: Value >120 bpm, Systolic blood pressure: Value <90 mmHg, Systolic blood pressure: Change >= 30 mmHg increase, Systolic blood pressure: Change >= 30 mmHg decrease. One participant could have more than one vital sign abnormality.
Measured: Day 1 up to 32 days after last dose of CAZ-AVI (maximum up to 46 days; maximum treatment duration was of 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start21 May 2021
- Primary completion4 May 2023
- Study completion4 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hospital-Acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774094
- Sponsor's protocol ID
- C3591026
- Status last verified
- Apr 2024
- First submitted
- 5 Feb 2021
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04774094
- Acronym / sponsor ID
- C3591026
- Conditions
- Hospital-Acquired Pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 21 May 2021 (actual)
- Primary completion
- 4 May 2023 (actual)
- Study completion
- 4 May 2023 (actual)
- First posted
- 1 Mar 2021 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAZ-AVI | Experimental | Drug: Zavicefta, Ceftazidime-Avibactam |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zavicefta, Ceftazidime-AvibactamParticipants 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. | Drug | CAZ-AVI |
Primary outcome
Percentage of Participants With Clinical Cure at Test of Cure (TOC) Visit: Clinical Modified Intent-to-Treat (cMITT) Population
Time frame: TOC visit: any day from Day 21 to 25
Clinical cure: participants were considered to be a success for clinical response at TOC visit if the participants were not a clinical failure at end of treatment (EOT), and the participants were alive and all signs and symptoms of pneumonia were resolved or improved to an extent that no antibacterial therapy for HAP was taken between EOT and TOC inclusive. Gram negative is abbreviated as gram -ve and gram positive as gram +ve.
11 secondary outcomes
Percentage of Participants With Clinical Cure at EOT Visit: cMITT Population
Time frame: EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days)
Percentage of Participants With Clinical Cure at EOT and TOC Visit: Microbiological Modified Intent-to-Treat (mMITT) Population
Time frame: EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25
Percentage of Participants With Favorable Per-Participant Microbiological Response at the EOT and TOC Visits: mMITT Population
Time frame: EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25
Percentage of Participants With Favorable Per-Pathogen Microbiological Response at the EOT and TOC Visits: mMITT Population
Time frame: EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25
Percentage of Participants With Clinical Cure at the EOT and TOC Visits in Participants With Gram-negative Baseline Pathogens Resistant to Ceftazidime: mMITT Population
Time frame: EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25
Percentage of Participants With Favorable Per-Participant Microbiologic Response at the EOT and TOC Visits in Participants With Gram-negative Baseline Pathogens Resistant to Ceftazidime: mMITT Population
Time frame: EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25
Percentage of Participants With Death Due to Any Cause at the TOC Visit and at Day 28 Visit: cMITT Population
Time frame: TOC visit: any day from Day 21 to 25; Day 28
Percentage of Participants With Death Due to Any Cause at the TOC Visit and at Day 28 Visit: mMITT Population
Time frame: TOC visit: any day from Day 21 to 25; Day 28
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Day 1 up to 32 days after last dose of CAZ-AVI (maximum up to 46 days; maximum treatment duration was of 14 days)
Number of Participants With Clinically Significant Post-Baseline Laboratory Test Abnormalities
Time frame: Day 1 up to 32 days after last dose of CAZ-AVI (maximum up to 46 days; maximum treatment duration was of 14 days)
Number of Participants With Vital Signs Data According to Pre-defined Criteria
Time frame: Day 1 up to 32 days after last dose of CAZ-AVI (maximum up to 46 days; maximum treatment duration was of 14 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
56 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zavicefta, Ceftazidime-Avibactam in people with Hospital-Acquired Pneumonia, run by Pfizer at 56 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Clinical Cure at Test of Cure (TOC) Visit: Clinical Modified Intent-to-Treat (cMITT) Population (time frame: TOC visit: any day from Day 21 to 25). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.