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In set-up: protocol development.

aim

The aim of this pilot study is to assess success factors and barriers for the preparation of a Phase 3 clinical study to investigate the efficacy and safety of a vaccine candidate for the prevention of Invasive Extraintestinal pathogenic Escherichia coli Disease (IED) in adults aged 60 years and older.

why this is important

Extraintestinal pathogenic Escherichia coli (ExPEC) is the most common and rising cause of bacteremia and bloodstream infections worldwide. Increasing multidrug resistance among ExPEC strains constitutes a major challenge for the prevention and treatment of ExPEC infections. IED is defined as an acute illness consistent with bacterial infection that is microbiologically confirmed by the isolation and identification of E. coli from blood or other normally sterile body sites, or by the isolation and identification of E. coli from urine in a patient with signs and symptoms of invasive disease (presence of systemic inflammatory response syndrome [SIRS], sepsis or septic shock) and no other identifiable source of infection. Although IED affects all age categories, adults aged 60 years or older have an increased risk of developing IED. To date, there is no vaccine available to prevent IED. ExPEC10V is a 10-valent vaccine candidate in development by Janssen R&D for the prevention of IED in adults aged 60 years and older.

methods

A Phase 3 clinical study is planned to investigate the efficacy and safety of this vaccine. To obtain insight in the feasibility and design of the Phase 3 study, a pilot study is required. This pilot study is a prospective, multicenter, observational study conducted in a maximum of eight countries in Europe, North-America and Asia. Participant recruitment will be done in primary care (mostly by general practitioners). In each participating country a local primary care network encompassing approximately 40,000 persons and a local hospital, where patients are referred to in case of a suspicion of IED, will participate in this study.