Study to Collect Information About Invasive Disease Caused by Extraintestinal Pathogenic Escherichia Coli-2 (EXPECT-2)

NCT04117113 | Completed

• 1 other identifier: VAC52416BAC0006
• Study Type: observational
• Target: 238
• Locations: 8 countries
• Sites: 8

Brief Summary

The purpose of this study is to collect information from study participants who are hospitalized with an invasive disease caused by Extraintestinal pathogenic E. coli (ExPEC). This information will be used to support the development of a new vaccine to prevent Extraintestinal pathogenic Escherichia coli (ExPEC). E. coli bacteria are a leading cause of serious infections. Especially adults older than 60 years have a higher risk of developing such infections. To date, there is no vaccine available to prevent E. coli infections. To support the development of a vaccine, more information about E. coli infections is first needed. This information will be collected in the current study, such as:

• Medical information such as medical history, diagnosis, duration of hospitalization
• Treatment and outcome of the Extraintestinal pathogenic Escherichia coli (ExPEC)
• Laboratory information

Conditions

E. Coli Infection

Outcome Measures

Primary Outcomes (3)

• Distribution of E. coli O-serotypes causing IED in adults aged 60 years or older, as percentage of the total study population.

  12 months

• Distribution of E. coli O-genotypes causing IED in adults aged 60 years or older, as percentage of the total study population.

  12 months

• Distribution of IED in adults aged 60 years or older over the following clinical case definitions: "Pyelonephritis", "Urosepsis", "Meningitis", "Arthritis", "Sepsis of unknown origin" and "Others", as a percentage of the total study population.

  12 months

Secondary Outcomes (8)

• Proportion of non-bacteremic and bacteremic IED of the total number of IED cases.

  12 months

• Listing of IED patients with specific risk factors for IED as a proportion of all IED patients.

  12 months

• Type of infection (community acquired, hospital-acquired or healthcare-associated) .

  12 months

• Source of infection (presence of an infectious focus within 30 days prior to IED).

  12 months

• Susceptibility of the cultured E. coli strains to antibiotics as determined by EUCAST standards (version9.0) to β-lactam antibiotics.

  12 months

Study Arms (1)

Elderly, 60+ hospitalized with Invasive ExPEC Disease

Patients 60 years or older hospitalized with Invasive Extraintestinal Pathogenic Escherichia coli Disease.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized and having culture-confirmed IED.

You may qualify if:

• Patients aged 60 years or older and hospitalized for IED at the start of the study.
• Culture confirmation of E. coli (1) in normally sterile body sites including blood, and/or (2) in urine in the presence of clinical criteria of an invasive infection (raise in SOFA score \>1, sepsis, or septic shock consequent to the infection).
• For those countries and/or study sites where no waiver for informed consent/assent has been obtained prior to data collection, eligible patients must sign a participation agreement/ICF/IAF allowing data collection and source data verification in accordance with local requirements and/or sponsor policy. For deceased patients, a participation agreement/ICF/IAF must be signed by the patient's next of kin.

Sponsors & Collaborators

• UMC Utrecht: 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, Italy

Location

Janssen Pharmaceutical K.K.

Tokyo, Chiyoda-ku, 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

Biospecimen

Retention: SAMPLES WITHOUT DNA

E. coli isolates from blood, urine, or any other normally sterile body site.

MeSH Terms

Conditions

Escherichia coli Infections

Condition Hierarchy (Ancestors)

Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Miquel B Ekkelenkamp, MD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Molecular Epidemiology of Infectious Diseases

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: October 7, 2019
• Study Start: October 22, 2019
• Primary Completion: January 31, 2021
• Study Completion: May 12, 2021
• Last Updated: September 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

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