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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04882085
Recruitment Status : Recruiting
First Posted : May 11, 2021
Last Update Posted : June 2, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Urinary Tract Infection Acute Pyelonephritis Hospital Acquired Pneumonia Ventilator-associated Pneumonia Bacteremia Intra-abdominal Infection Drug: Zavicefta, Ceftazidime-Avibactam Drug: Best Available Treatment Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 26, 2021
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. The percentage of participants in Microbiologically Modified Intent to Treat (mMITT) analysis set having clinical cure [ Time Frame: Test of Cure (TOC, Day 21 - 25) ]

Secondary Outcome Measures :
  1. The percentage of participants in mMITT analysis set 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) ]
  2. The percentage of participants in Microbiologically Evaluable (ME) analysis set 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) ]
  3. The percentage of participants in ME analysis set having clinical cure [ Time Frame: Test of Cure (TOC, Day 21-Day 25) ]
  4. The percentage of participants in mMITT analysis set having favorable microbiological response [ Time Frame: Test of Cure(TOC, Day 21-Day 25) ]
  5. The percentage of participants in mMITT analysis set having favorable microbiological response [ 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) ]
  6. The percentage of participants in ME analysis set having favorable microbiological response [ 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) ]
  7. The percentage of participants in ME analysis set having favorable microbiological response [ Time Frame: Test of Cure(TOC, Day 21-Day 25) ]
  8. The percentage of participants who have died due to any cause [ Time Frame: Day 28 ]
  9. The number of treatment-emergent adverse events [ Time Frame: up to 32 days after the last dose of study intervention ]
  10. The percentage of participants experiencing the AEs [ Time Frame: up to 32 days after the last dose of study intervention ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04882085


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04882085    
Other Study ID Numbers: C3591033
First Posted: May 11, 2021    Key Record Dates
Last Update Posted: June 2, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Pneumonia
Urinary Tract Infections
Bacteremia
Pneumonia, Ventilator-Associated
Intraabdominal Infections
Healthcare-Associated Pneumonia
Pyelonephritis
Disease Attributes
Pathologic Processes
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
Urologic Diseases
 Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Bacterial Infections
Bacterial Infections and Mycoses
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Cross Infection
Iatrogenic Disease
Nephritis, Interstitial
Nephritis
Kidney Diseases
Pyelitis