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

NCT04087681 | Completed

• 1 other identifier: VAC52416BAC0005
• Study Type: observational
• Target: 4,479
• Locations: 8 countries
• Sites: 8

Brief 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.

Conditions

E.Coli Infections

Keywords

Extraintestinal pathogenic Escherichia coli (ExPEC); Invasive ExPEC disease (IED); Pilot study

Outcome Measures

Primary Outcomes (7)

• Participant enrolment rate (% of patients screened/invited vs. enrolled)

  Participant enrolment rate (% of patients screened/invited vs. enrolled)

  3 months

• Number of hospital admissions of participants reported by the hospital versus the number of hospital admissions obtained through medical record checks by the primary care center versus the number of hospital admissions reported by participants narrative

  Number of hospital admissions of participants reported by the hospital versus the number of hospital admissions obtained through medical record checks by the primary care center versus the number of hospital admissions reported by participants narrative

  12 months

• Number of IED hospital admissions of participants reported by the hospital vs. the number of IED hospital admissions obtained by medical record checks of the primary care center vs. the number of IED hospital admissions reported by participants narrative

  Number of IED hospital admissions of participants reported by the hospital vs. the number of IED hospital admissions obtained by medical record checks of the primary care center vs. the number of IED hospital admissions reported by participants narrative

  12 months

• Description of medical assessment pathways based on participants medical files.

  Description of medical assessment pathways based on participants medical

  12 months

• Description of standard of care diagnostic methods based on participants medical files.

  Description of standard of care diagnostic methods based on participants medical files.

  12 months

• Description of treatment of bacteremic and nonbacteremic IED based on participants medical files.

  Description of treatment of bacteremic and nonbacteremic IED based on participants medical files.

  12 months

• Incidence of IED (number % of IED cases in the group of study participants)

  Incidence of IED (number % of IED cases in the group of study participants)

  12 months

Study Arms (1)

Elderly 60+ preferably those with increased risk of IED

Study participants are aged 60 years or older in stable health, preferably with a history of urinary tract infection in the previous 10 years.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes male and female participants aged 60 years or older in stable health, preferably at increased risk for IED. A total of 6,000 study participants will be recruited. At least 50% of the study participants will be healthy elderly aged 60 years or older with a history of UTI in the previous ten years. The other 50% of participants will be healthy elderly aged 60 years or older with no (known) history of UTI in the previous ten years.

You may qualify if:

• 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.

Sponsors & Collaborators

• MJM Bonten: lead
• Janssen Research & Development, LLC: collaborator
• Innovative Medicines Initiative: collaborator

Study Sites (8)

Duke Clinical Research Institute

Durham, North Carolina, 27701, United States

Location

Duke Clinical Research Institute

Greater Sudbury, Canada

Location

Chu Limoges - Cic

Limoges, 87042, France

Location

UKK Uniclinic Cologne

Cologne, 50937, Germany

Location

University of Verona

Verona, 37129, Italy

Location

Janssen Pharmaceutical K.K.

Tokyo, Chiyoda-ku, - 5-2 Nishikanda, 3-chome, Japan

Location

- Andalusian Public Foundation for Health Research Management in Seville (FISEVI)

Seville, 41013, Spain

Location

University of Oxford

Oxford, OX1 2JD, United Kingdom

Location

Study Officials

• Miquel Ekkelenkamp, Dr.

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor doctor

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 12, 2019
• Study Start: September 28, 2019
• Primary Completion: May 7, 2021
• Study Completion: June 21, 2021
• Last Updated: September 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); US (1); ES (1); FR (1); CA (1); GB (1); DE (1); JP (1)