E.Coli InfectionsEXPECT-1NCT04087681
Study to Collect Information About Invasive Disease Caused by Extraintestinal Pathogenic Escherichia Coli (EXPECT-1)
An observational study of E.Coli Infections, run by MJM Bonten at 8 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- E.Coli Infections
- How many people
- 4,479 participants
- Where
- 8 sitesin 8 countries
- Study dates
- 28 Sep 2019to 21 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 8 countries.
8 sites in 8 countries
United States1 site
Duke Clinical Research Institute
Durham, North Carolina, 27701
Japan1 site
Janssen Pharmaceutical K.K.
Tokyo, Chiyoda-ku, - 5-2 Nishikanda, 3-chome
Spain1 site
- Andalusian Public Foundation for Health Research Management in Seville (FISEVI)
Seville, 41013
About this study
Official title: 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
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.
Read the 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
- Keywords
- Extraintestinal pathogenic Escherichia coli (ExPEC), Invasive ExPEC disease (IED), Pilot study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant enrolment rate (% of patients screened/invited vs. enrolled)
Participant enrolment rate (% of patients screened/invited vs. enrolled)
Measured: 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
Measured: 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
Measured: 12 months
Description of medical assessment pathways based on participants medical files.
Description of medical assessment pathways based on participants medical
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start28 Sep 2019
- Primary completion7 May 2021
- Study completion21 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for E.Coli InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,479 participants (actual)
Sponsor and investigators
- Lead sponsor
- MJM Bonten
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Research & Development, LLC, Innovative Medicines Initiative
- Responsible party
- Sponsor-investigator, MJM Bonten, UMC Utrecht
- Investigators
- Miquel Ekkelenkamp, Dr., Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087681
- Sponsor's protocol ID
- VAC52416BAC0005
- Acronym
- EXPECT-1
- Status last verified
- Sep 2021
- First submitted
- 9 Sep 2019
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04087681
- Acronym / sponsor ID
- EXPECT-1 / VAC52416BAC0005
- Conditions
- E.Coli Infections
- Keywords
- Extraintestinal pathogenic Escherichia coli (ExPEC), Invasive ExPEC disease (IED), Pilot study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,479 participants (actual)
- Lead sponsor
- MJM BontenUniversity, hospital or other
- Collaborators
- Janssen Research & Development, LLC, Innovative Medicines Initiative
- Study start
- 28 Sep 2019 (actual)
- Primary completion
- 7 May 2021 (actual)
- Study completion
- 21 Jun 2021 (actual)
- First posted
- 12 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Participant enrolment rate (% of patients screened/invited vs. enrolled)
Time frame: 3 months
Participant enrolment rate (% of patients screened/invited vs. enrolled)
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
Time frame: 12 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 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
Time frame: 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
Description of medical assessment pathways based on participants medical files.
Time frame: 12 months
Description of medical assessment pathways based on participants medical
Description of standard of care diagnostic methods based on participants medical files.
Time frame: 12 months
Description of standard of care diagnostic methods based on participants medical files.
Description of treatment of bacteremic and nonbacteremic IED based on participants medical files.
Time frame: 12 months
Description of treatment of bacteremic and nonbacteremic IED based on participants medical files.
Incidence of IED (number % of IED cases in the group of study participants)
Time frame: 12 months
Incidence of IED (number % of IED cases in the group of study participants)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miquel Ekkelenkamp, Dr. principal investigator
UMC Utrecht
8 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of E.Coli Infections, run by MJM Bonten at 8 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada, France, Germany, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant enrolment rate (% of patients screened/invited vs. enrolled) (time frame: 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021; AzTrials last refreshed its copy on 3 Nov 2026.