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

Pfizer

Status and phase: Completed; Phase 4

Conditions: Intra-abdominal Infection; Ventilator-associated Pneumonia; Urinary Tract Infection; Bacteremia; Hospital Acquired Pneumonia; Acute Pyelonephritis

Treatments: Drug: Zavicefta, Ceftazidime-Avibactam; Drug: Best Available Treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT04882085

C3591033

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

CAZ-AVI

Experimental group

Description:

ceftazidime 2g plus avibactam 0.5g

Treatment:

Drug: Zavicefta, Ceftazidime-Avibactam

Best Available Treatment

Active Comparator group

Description:

Based on investigative site practice and local epidemiology and guideline

Treatment:

Drug: Best Available Treatment