OZAVIE : Prospective observational study in patients treated with Zavicefta® (ceftazidime/avibactam) under real conditions of use

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50265
• EU PAS number:
  EUPAS26550
• Study ID:
  50265
• Official title and acronym:
  OZAVIE : Prospective observational study in patients treated with Zavicefta® (ceftazidime/avibactam) under real conditions of use
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  France

  Portugal
• Study description:
  ZAVICEFTA® is an association of a 3GC with a new β-lactamase inhibitor and avibactam, which was developed in order to circumvent the main resistance mechanisms to ceftazidime, the major one of which being the production of β-lactamases. Given its spectrum of activity and tolerability, it has raised interest in hospital departments. Phase III studies have enabled the molecule to be registered in its 4 current indications, which are i) complicated intra-abdominal infections (IAIc), ii) complicated urinary tract infections (UTIc), including pyelonephritis, iii) nosocomial pneumonias (NP), including mechanical ventilation-acquired pneumonias (MVAP) and iv) the treatment of infections due to aerobic Gram-negative bacteria in adult patients for whom the treatment options are limited. The aim of this observational study is to collect data on use under actual conditions and tolerability in this specific type of unit, the hospital departments. Primary objective: - To describe the use of ZAVICEFTA® in hospitalised subjects suffering from infection in whom the decision has been taken to treat with ZAVICEFTA®, either alone or in combination. Secondary objectives: - To measure the effectiveness of ZAVICEFTA® at the end of treatment, at 30 days after the start of treatment and at 28 days after the end of treatment - To assess the tolerability of ZAVICEFTA® - To assess in-hospital mortality and hospital readmissions - To assess length of hospital and intensive care unit stay - To define the characteristics of subjects treated with ZAVICEFTA®, particularly their comorbidities, - To describe the sensitivity of pathogens to ZAVICEFTA® and potential alternative therapies to this treatment, - To explain the reason for choosing treatment with ZAVICEFTA®
• Study status:
  Ongoing

Research institutions and networks

Institutions

Pfizer

Multiple centres: 55 centres involved in the study

Networks

SPILF

Study timelines

Date when funding contract was signed

Planned: 27/11/2018

Actual: 26/11/2018

Study start date

Planned: 01/02/2019

Actual: 29/03/2019

Data analysis start date

Planned: 01/05/2020

Date of final study report

Planned: 29/12/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

PFIZER

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable