Efficacy and Safety of CAZ-AVI in the Treatment of Infections Due to Carbapenem-resistant G- Pathogens in Chinese Adults

August 1, 2024 updated by: Pfizer

AN OPEN-LABEL, RANDOMIZED, MULTI-CENTER, ACTIVE-CONTROLLED STUDY TO ESTIMATE THE EFFICACY AND SAFETY OF CEFTAZIDIME-AVIBACTAM (CAZ-AVI) VERSUS BEST AVAILABLE TREATMENT (BAT) IN THE TREATMENT OF INFECTIONS DUE TO CARBAPENEM-RESISTANT GRAM-NEGATIVE PATHOGENS IN CHINESE ADULTS

This is an open-label, randomized, multi-center, interventional, active-controlled Phase 4 study to evaluate the efficacy and safety of CAZ-AVI versus BAT in the treatment of infected participants with selected infection types (Hospital Acquired Pneumonia [HAP] (including Ventilator-Associated Pneumonia [VAP]); Complicated Urinary-Tract Infection [cUTI]; Complicated Intra-Abdominal Infection [cIAI]; Bloodstream Infection [BSI]) due to carbapenem-resistant Gram-negative pathogens in China.This study will be an estimation study. The statistical inference will be based on point estimate and confidence interval.

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.
60

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Jiangyin, China, 214400
        • Jiangyin People's Hospital
      • Shanghai, China, 200240
        • Shanghai Fifth People's Hospital, Fudan University
    • Anhui
      • Bengbu, Anhui, China, 233004
        • The First Affiliated Hospital of Bengbu Medical College
      • Bengbu, Anhui, China, 233000
        • The First Affiliated Hospital of Bengbu Medical
      • Chizhou, Anhui, China, 247000
        • Chizhou People's Hospital
      • Fuyang, Anhui, China, 236000
        • Fuyang People's Hospital
    • Beijing
      • Beijing, Beijing, China, 100191
        • Peking University Third Hospital
    • Fujian
      • Xiamen, Fujian, China, 361004
        • Zhongshan Hospital Xiamen University
    • Guangdong
      • Guangzhou, Guangdong, China, 510180
        • Guangzhou First People's Hospital
      • Qingyuan, Guangdong, China, 511518
        • 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
    • Guangxi
      • Guilin, Guangxi, China, 541001
        • Affiliated Hospital of Guilin Medical College
    • Guizhou
      • Zunyi, Guizhou, China, 563000
        • Affiliated Hospital of Zunyi Medical University
    • 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
      • Zhengzhou, Henan, China, 450003
        • Henan Provincial People's Hospital
      • Zhengzhou, Henan, China, 450000
        • Henan Provincial People's Hospital
    • Inner Mongolia Autonomous Region
      • Baotou, Inner Mongolia Autonomous Region, China, 014000
        • Baotou Central Hospital
    • Jiangsu
      • Jiangyin, Jiangsu, China, 214400
        • Jiangyin People's Hospital
      • Xuzhou, Jiangsu, China, 221006
        • Affiliated Hospital of Xuzhou Medical University
      • Yangzhou, Jiangsu, China, 225001
        • Subei People's Hospital of Jiangsu province
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Jiangxi Provincial People's Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Huashan Hospital, Fudan University
    • Sichuan
      • Chengdu, Sichuan, China, 610055
        • Chengdu Xinhua Hospital
    • Tianjin
      • Tianjin, Tianjin, China, 300222
        • Tianjin Chest Hospital
    • Yunnan
      • Kunming, Yunnan, China, 650034
        • The First People's Hospital of kunming
      • Kunming, Yunnan, China, 650034
        • The First People's Hospital of Kunming (South Hospital)
      • Kunming, Yunnan, China, 650224
        • The First People's Hospital of Kunming Ganmei Hospital (North Hospital)
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310014
        • Zhejiang Provincial People's Hospital
      • Hangzhou, Zhejiang, China, 310013
        • Zhejiang Hospital
      • Lishui, Zhejiang, China, 323000
        • Lishui People's Hospital
      • Taizhou, Zhejiang, China, 317000
        • Taizhou Hospital of Zhejiang Province
      • 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female >18 years of age
  • Participant must have a diagnosis of an infection (HAP/VAP, cUTI, cIAI, BSI) due to confirmed carbapenem-resistant aerobic Gram-negative pathogens, requiring administration of IV antibacterial therapy
  • Participant who had received appropriate prior empiric antibacterial therapy for a carbapenem-resistant pathogen must meet at least 1 of the following criteria: no or no more than 24h; worsening of objective symptoms or signs after at least 48 hours of antibacterial therapy; no change of objective symptoms or signs after at least 72 hours of antibacterial therapy.
  • Capable of giving signed informed consent

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 more than 21 days of treatment
  • Participants who need more than 3 systemic antibiotics as part of best available treatment (BAT)
  • 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).
  • Participant is pregnant or breastfeeding.
  • 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: Randomized
  • Interventional Model: Parallel 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
ceftazidime 2g plus avibactam 0.5g
Drug: Zavicefta, Ceftazidime-Avibactam
CAZ-AVI 2.5 g (2 g ceftazidime + 0.5 g avibactam) administered IV as a 2 hour infusion every 8 hours. Dose adjustments are available for participants with CrCL ≤50 mL/min.
Active Comparator: Best Available Treatment
Based on investigative site practice and local epidemiology and guideline
Drug: Best Available Treatment
main treatment expected to be used as either monotherapy or in combination are colistin, tigecycline, fosfomycin, amikacin, and meropenem

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
Measure Description
Time Frame
Percentage of Participants With Clinical Cure at Test of Cure (TOC) Visit - Microbiologically Modified Intent-to-Treat (mMITT) Analysis Set
Time Frame: At TOC visit (From Day 21 up to Day 24)
Clinical cure was defined as improvement in baseline signs and symptoms such that no further antimicrobial treatment was required for the index infection (i.e, complicated intra-abdominal infection [cIAI], complicated urinary-tract infection [cUTI], hospital-acquired pneumonia/ventilator-associated pneumonia [HAP/VAP] or bloodstream infection [BSI]) after study treatment. Also, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. The clinical response was assessed by the independent adjudication committee. 95 percent (%) confidence interval (CI) was calculated using Jeffrey's method.
At TOC visit (From Day 21 up to Day 24)

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
Measure Description
Time Frame
Percentage of Participants With Clinical Cure at TOC Visit - Microbiologically Evaluable (ME) Analysis Set
Time Frame: At TOC visit (From Day 21 up to Day 24)
Clinical cure: improvement in baseline signs and symptoms such that no further antimicrobial treatment was required for index infection (i.e. cIAI, cUTI, HAP/VAP or BSI) after study treatment. Also, for cIAI participants, no unplanned drainage or surgical intervention was necessary since initial procedure. 95% CI based on Jeffrey's method. ME analysis set (sub-set of mMITT): participants who received 3 days of study intervention, or received study intervention for >=48 hours with >= 80% compliance, or for <48 hours before discontinuation due to adverse event, no concomitant antibiotics against baseline carbapenem-resistant gram negative pathogens between first dose and TOC (excluding participants with failed study therapy requiring additional antibiotics), had baseline organisms genetically confirmed by central microbiological testing, no indeterminate clinical outcome at end of treatment (EOT) or TOC visits, no important protocol deviations that affect assessment of efficacy.
At TOC visit (From Day 21 up to Day 24)
Percentage of Participants With Clinical Cure at End of Treatment (EOT) Visit -mMITT Analysis Set
Time Frame: At EOT visit (up to 24 hours after the last infusion on Day 14)
Clinical cure was defined as improvement in baseline signs and symptoms such that no further antimicrobial treatment was required for the index infection (i.e., cIAI, cUTI, HAP/VAP or BSI) after study treatment. Also, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. The clinical response was assessed by the independent adjudication committee. 95% CI was calculated using Jeffrey's method.
At EOT visit (up to 24 hours after the last infusion on Day 14)
Percentage of Participants With Clinical Cure at EOT Visit - ME Analysis Set
Time Frame: At EOT visit (up to 24 hours after the last infusion on Day 14)
Clinical cure: improvement in baseline signs and symptoms such that no further antimicrobial treatment was required for index infection (i.e., cIAI, cUTI, HAP/VAP or BSI) after study treatment. Also, for cIAI participants, no unplanned drainage or surgical intervention was necessary since initial procedure. 95% CI based on Jeffrey's method. ME analysis set (sub-set of mMITT): participants who received 3 days of study intervention, or received study intervention for >=48 hours with >= 80% compliance, or for <48 hours before discontinuation due to adverse event, no concomitant antibiotics against baseline carbapenem-resistant gram negative pathogens between first dose and TOC (excluding participants with failed study therapy requiring additional antibiotics), had baseline organisms genetically confirmed by central microbiological testing, no indeterminate clinical outcome at EOT or TOC visits, no important protocol deviations that affect assessment of efficacy.
At EOT visit (up to 24 hours after the last infusion on Day 14)
Percentage of Participants With Favorable Per-Participant Microbiological Response at TOC Visit - mMITT Analysis Set
Time Frame: At TOC visit (From Day 21 up to Day 24)
Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification <10^3 colony forming units per milliliter [CFU/mL] for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/ clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). 95% CI was calculated using Jeffrey's method.
At TOC visit (From Day 21 up to Day 24)
Percentage of Participants With Favorable Per-Participant Microbiological Response at TOC Visit - ME Analysis Set
Time Frame: At TOC visit (From Day 21 up to Day 24)
Favorable microbiological response=eradication: absence (or urine quantification <10^3 CFU/mL for cUTI participants) of causative pathogen from appropriately obtained specimen at site of infection or presumed eradication: repeat culture of specimens were not performed/clinically indicated in participant who had clinical cure (specific to cIAI,HAP/VAP participants). 95% CI was calculated using Jeffrey's method. ME analysis set: participants received 3 days of study intervention,or received study intervention for >= 48 hours with >=80% compliance or for <48 hours before discontinuation due to adverse event, no concomitant antibiotics against baseline carbapenem-resistant gram negative pathogens between first dose and TOC (excluding participants with failed study therapy requiring additional antibiotics), had baseline organisms confirmed by central microbiological testing, no indeterminate clinical outcome at EOT/TOC, no important protocol deviations that affect assessment of efficacy.
At TOC visit (From Day 21 up to Day 24)
Percentage of Participants With Favorable Per-Participant Microbiological Response at EOT Visit - mMITT Analysis Set
Time Frame: At EOT visit (Up to 24 hours after last infusion on Day 14)
Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification <10^3 CFU/mL for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). 95% CI was calculated using Jeffrey's method.
At EOT visit (Up to 24 hours after last infusion on Day 14)
Percentage of Participants With Favorable Per-Participant Microbiological Response at EOT Visit - ME Analysis Set
Time Frame: At EOT visit (Up to 24 hours after last infusion on Day 14)
Favorable microbiological response=eradication: absence (or urine quantification <10^3 CFU/mL for cUTI participants) of causative pathogen from appropriately obtained specimen at site of infection or presumed eradication: repeat culture of specimens were not performed/clinically indicated in participant who had clinical cure (specific to cIAI,HAP/VAP participants). 95% CI was calculated using Jeffrey's method. ME analysis set: participants received 3 days of study intervention,or received study intervention for >= 48 hours with >=80% compliance or for <48 hours before discontinuation due to adverse event, no concomitant antibiotics against baseline carbapenem-resistant gram negative pathogens between first dose and TOC (excluding participants with failed study therapy requiring additional antibiotics), had baseline organisms confirmed by central microbiological testing, no indeterminate clinical outcome at EOT/TOC, no important protocol deviations that affect assessment of efficacy.
At EOT visit (Up to 24 hours after last infusion on Day 14)
Percentage of Participants With Favorable Per-Pathogen Microbiological Response at TOC Visit - mMITT Analysis Set
Time Frame: At TOC visit (From Day 21 up to Day 24)
Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification <10^3 CFU/mL for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). 95% CI was calculated using Jeffrey's method.
At TOC visit (From Day 21 up to Day 24)
Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT Visit - mMITT Analysis Set
Time Frame: At EOT visit (Up to 24 hours after last infusion on Day 14)
Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification <10^3 CFU/mL for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). 95% CI was calculated using Jeffrey's method.
At EOT visit (Up to 24 hours after last infusion on Day 14)
Percentage of Participants Who Died Due to Any Cause Until Day 28
Time Frame: From first dose of study intervention (Day 1) up to Day 28
Percentage of participants who died due to any cause up to Day 28 was reported in this outcome measure. The 95% CI was calculated using the Jeffrey's method.
From first dose of study intervention (Day 1) up to Day 28
Number of Participants With Treatment-Emergent Adverse Events
Time Frame: From start of study treatment on Day 1 up to 32 days after the last dose of study intervention (Up to 46 days)
An adverse event (AE) was any untoward medical occurrence in a study participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent adverse event (TEAE) was any AE that started after the study intervention start date and time.
From start of study treatment on Day 1 up to 32 days after the last dose of study intervention (Up to 46 days)
Number of Participants With Discontinuation Due to Adverse Events
Time Frame: From start of study treatment on Day 1 up to 32 days after the last dose of study intervention (Up to 46 days)
Number of participants who discontinued the study due to adverse events were reported in this outcome measure. Discontinuations from study due to TEAEs included all participants with an AE record indicating that the AE caused permanent discontinuation from the study. Permanent discontinuations from any study intervention due to TEAEs included participants with an AE record indicating that action taken with study treatment was drug withdrawn but AE did not cause the participant to be discontinued from study.
From start of study treatment on Day 1 up to 32 days after the last dose of study intervention (Up to 46 days)
Number of Participants With Potentially Clinically Significant Post-baseline Hematology Values
Time Frame: From first dose of study treatment (Day 1) until TOC (Up to Day 24)
Potentially clinically significant hematology parameters included Hemoglobin (gram/deciliter), Hematocrit (%), Erythrocytes (10^12/Liter [L]): value < 0.8*lower limit of normal (LLN) and change (Chg) > 20% decrease, value > 1.3*upper limit of normal (ULN) and Chg > 30% increase. Platelets (10^9/L): Value < 0.65*LLN and Chg > 50% decrease, Value > 1.5*ULN and Chg > 100% increase. Leukocytes (10^9/L): Value < 0.65*LLN and Chg > 60% decrease, Value > 1.6*ULN and Chg > 100% increase. Lymphocytes (10^9/L): Value < 0.25*LLN and Chg > 75% decrease, Value > 1.5*ULN and Chg > 100% increase. Neutrophils (10^9/L): Value < 0.65*LLN and Chg > 75% decrease, Value > 1.6*ULN and Chg > 100% increase. Basophils (10^9/L), Eosinophils (10^9/L), Monocytes (10^9/L): Value > 4.0*ULN and Chg > 300% increase. Number of participants with potentially clinically significant values for any hematology parameters were reported in this outcome measure.
From first dose of study treatment (Day 1) until TOC (Up to Day 24)
Number of Participants With Potentially Clinically Significant Post-baseline Clinical Chemistry Values
Time Frame: From first dose of study treatment (Day 1) until TOC (Up to Day 24)
Potentially clinically significant criteria included Bilirubin(mg/dL): >2.0*ULN and Chg >150% increase (inc).Aspartate Aminotransferase,Alanine Aminotransferase(Units/Liter[U/L]):>3.0*ULN and Chg >200% inc.Alkaline Phosphatase(U/L):<0.5*LLN and Chg >80% decrease (dec),> 2.0*ULN and Chg >100% inc.Protein,Albumin(g/dL):<0.5*LLN and Chg >50% dec,>1.5*ULN and Chg >50% inc.Blood Urea Nitrogen(mg/dL):<0.2*LLN and Chg >100% dec, >3.0*ULN and Chg >200% inc.Creatinine(mg/dL):>2.0*ULN and Chg >100% inc.Sodium(milliequivalent[mEq]/L):<0.85*LLN and Chg >10% dec, >1.1*ULN and Chg >10% inc.Potassium,Chloride(mEq/L):<0.8*LLN and Chg >20% dec, >1.2*ULN and Chg >20% inc.Calcium(mg/dL):<0.7*LLN and Chg >30% dec,> 1.3*ULN and Chg >30% inc.Bicarbonate(mEq/L):<0.7*LLN and Chg >40% dec, >1.3*ULN and Chg >40% inc.Glucose(mg/dL):<0.6*LLN and Chg >40% dec, >3.0*ULN and Chg >200% inc.Number of participants with potentially clinically significant values for any clinical chemistry parameters were reported.
From first dose of study treatment (Day 1) until TOC (Up to Day 24)

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.
August 26, 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.
August 31, 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.
August 31, 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).
April 27, 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.
May 10, 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.
May 11, 2021

Study Record Updates

Last Update Posted (Actual)

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.
October 21, 2024

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 1, 2024

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, 2024

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.
  • C3591033

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

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