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

Completed

Conditions studied: E.Coli Infections

In brief

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.

Key facts

Study ID

NCT04087681

Run by

MJM Bonten

People needed

4479

Starts

2019-09-28

Expected to finish

2021-06-21

Last updated by the study team

2021-09-21

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participant is willing to provide written informed consent prior to inclusion.
• Participant is male or female preferably with a history of UTI in the previous 10 years. Participant without a (known) history of UTI in the previous ten years may also be enrolled.
• Participant is aged 60 years or older on the day of signing the informed consent form (ICF).
• Participant is willing to be available for contact with investigator for the duration of the study.
• Participant is ambulatory and lives in the community or in assisted-living or long-term care residential facility that provides minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.
• Based on the clinical judgment of the investigator, participant must be in stable health. Participants may have underlying illnesses such as hypertension, congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), type 2 diabetes mellitus, as long as their signs and symptoms are stable and medically controlled.

You may not qualify if…

• Participant has a serious chronic disorder, including severe COPD or clinically significant CHF, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, Alzheimer's disease, or has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g. compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments.
• Participant has history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence).
• Participant has had major psychiatric illness and/or drug or alcohol abuse which in investigators opinion would compromise the participant's safety and/or compliance with the study procedures.
• Participant who, in the opinion of the investigator, is unlikely to adhere to the requirements of the study, or is unlikely to complete the full course of the study.

Where it is running

• Duke Clinical Research Institute — Durham, North Carolina, United States
• Duke Clinical Research Institute — Greater Sudbury, Canada
• Chu Limoges - Cic — Limoges, France
• UKK Uniclinic Cologne — Cologne, Germany
• University of Verona — Verona, Italy
• Janssen Pharmaceutical K.K. — Tokyo, Chiyoda-ku, Japan
• - Andalusian Public Foundation for Health Research Management in Seville (FISEVI) — Seville, Spain
• University of Oxford — Oxford, United Kingdom

Full record on ClinicalTrials.gov

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