Phase 4 N=60 Randomized Treatment

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

Urinary Tract Infection · Acute Pyelonephritis · Hospital Acquired Pneumonia · Ventilator-associated Pneumonia · Bacteremia

Bottom Line

View on ClinicalTrials.gov: NCT04882085 ↗

Enrolled (actual)

Serious AEs

30.5%

Results posted

Oct 2024

Primary outcome: Primary: Percentage of Participants With Clinical Cure at Test of Cure (TOC) Visit - Microbiologically Modified Intent-to-Treat (mMITT) Analysis Set — 59.3; 25.9 Percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Zavicefta, Ceftazidime-Avibactam (Drug); Best Available Treatment (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Aug 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Clinical Cure at Test of Cure (TOC) Visit - Microbiologically Modified Intent-to-Treat (mMITT) Analysis Set	59.3; 25.9	—
SECONDARY Percentage of Participants With Clinical Cure at TOC Visit - Microbiologically Evaluable (ME) Analysis Set	78.6; 26.3	—
SECONDARY Percentage of Participants With Clinical Cure at End of Treatment (EOT) Visit -mMITT Analysis Set	66.7; 29.6	—
SECONDARY Percentage of Participants With Clinical Cure at EOT Visit - ME Analysis Set	78.6; 31.6	—
SECONDARY Percentage of Participants With Favorable Per-Participant Microbiological Response at TOC Visit - mMITT Analysis Set	59.3; 25.9	—
SECONDARY Percentage of Participants With Favorable Per-Participant Microbiological Response at TOC Visit - ME Analysis Set	71.4; 31.6	—
SECONDARY Percentage of Participants With Favorable Per-Participant Microbiological Response at EOT Visit - mMITT Analysis Set	81.5; 33.3	—
SECONDARY Percentage of Participants With Favorable Per-Participant Microbiological Response at EOT Visit - ME Analysis Set	78.6; 42.1	—
SECONDARY Percentage of Participants With Favorable Per-Pathogen Microbiological Response at TOC Visit - mMITT Analysis Set	0; 100.0; 63.2; 30.4; 37.5; 0	—
SECONDARY Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT Visit - mMITT Analysis Set	0; 100.0; 89.5; 39.1; 75.0; 0	—
SECONDARY Percentage of Participants Who Died Due to Any Cause Until Day 28	13.3; 13.8	—
SECONDARY Number of Participants With Treatment-Emergent Adverse Events	24; 26	—
SECONDARY Number of Participants With Discontinuation Due to Adverse Events	0; 0; 1; 6	—
SECONDARY Number of Participants With Potentially Clinically Significant Post-baseline Hematology Values	7; 13	—
SECONDARY Number of Participants With Potentially Clinically Significant Post-baseline Clinical Chemistry Values	4; 7	—

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04882085). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.