NCT04087681

Study to Collect Information About Invasive Disease Caused by Extraintestinal Pathogenic Escherichia Coli (EXPECT-1)

Pilot Study to Assess Success Factors and Barriers for Preparation of a Phase 3 Study With ExPEC10V in Adults Aged 60 Years or Older and in Stable Health

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4,479 (actual)
• Sponsor: MJM Bonten · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to collect information from study participants who develop an invasive disease caused by Extraintestinal pathogenic E. coli (ExPEC) during a period of 12 months. This information will be used to support the development of a new vaccine to prevent ExPEC infections.

Detailed description

Invasive ExPEC disease (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 and no other identifiable source of infection. 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. 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. 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. Database screening at the primary care centers will be performed to identify and invite potential eligible study participants. Upon consent, each study participant will be followed for a period of maximum 12 months after enrollment in the study. At baseline, demographic data and medical history data will be collected. During the follow-up period, any referral of study participants to a hospital for any reason including IED will be collected. IED identification and Medical Resource Utilization (MRU) during the follow-up period will be performed by regular telephone calls with all study participants. At the end of the study, the primary care files will also be checked for MRU. If a participant is diagnosed with IED and admitted to the hospital, the following data will be collected: medical history and treatment received 90 days prior to the IED, clinical and laboratory data, data on the treatment and outcome of IED and data on MRU related to IED. Data will be collected on Day 1 of IED diagnosis (signs/ symptoms) and Day 28 after IED diagnosis.

Conditions

• E.Coli Infections

Timeline

• Start date: 2019-09-28
• Primary completion: 2021-05-07
• Completion: 2021-06-21
• First posted: 2019-09-12
• Last updated: 2021-09-21

Locations

8 sites across 8 countries: United States, Canada, France, Germany, Italy, Japan, Spain, United Kingdom