Extended Spectrum Beta Lactamases (ESBL) E. ColiNCT04764500
Developing Microbials to Fight Extended-spectrum Beta-lactamase (ESBL)-Producing Escherichia Coli
An observational study of Extended Spectrum Beta Lactamases (ESBL) E. Coli, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This study is to identify and isolate well-defined microbials (non-ESBL E. coli) in an observational setting exploring natural gastrointestinal decolonization of humans colonized with ESBL E. coli. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Extended Spectrum Beta Lactamases (ESBL) E. Coli
- What is being tested?
- examination of stool sample, patient questionnaire and examination of blood sample
- How many people
- 39 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Jun 2019to 31 Dec 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Clients planning to travel to Southeast Asia will be recruited while receiving pre-travel health advice at the travel clinic of the Swiss Tropical and Public Health Institute in Basel.
Who may be able to join
- travelling to Southeast Asia (India, Bhutan, Nepal, Bangladesh, Myanmar, Thailand, Laos, Cambodia, Vietnam) for a maximum of 4 weeks.
Who cannot join
- other travelling destinations than mentioned above
- antibiotic use at the first sampling time
- Participants who are not colonized will serve as a control group for microbiome comparison
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Division of Clinical Microbiology
Basel, 4031
About this study
This study is to identify and isolate well-defined microbials (non-ESBL E. coli) in an observational setting exploring natural gastrointestinal decolonization of humans colonized with ESBL E. coli.
Read the detailed description
Antibiotic resistance is a severe threat to contemporary medicine. Effective approaches to fight multi-drug resistant pathogenic bacteria are needed.
This clinical observational study is to investigate whether express extended spectrum beta lactamases (ESBL) E. coli colonizing the human gut can be out-competed by other, ideally pan-sensitive strains (non-ESBL E. coli).
- Being tested
- examination of stool sample, patient questionnaire, examination of blood sample
- Keywords
- Antibiotic resistance, pan-sensitive strains (non-ESBL E. coli), multidrug resistant E. coli strains, ESBL E. coli displacement, multidrug resistant Enterobacteriaceae
- Medical subject headings
- Escherichia coli Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
examination of stool sampleOther
Each participant provides stool samples before and after travelling, after 2, 4, 6, 8, 10, 12, 16, 20 and 52 weeks. Stool samples will be used for isolating both a) ESBL E. coli strains and b) pan-sensitive E. coli strains. Part of the stool sample is stored for isolation of further E. coli clones and microbiota analysis of the isolation of other microbiota strains. All found Enterobacteriaceae will be screened for additional resistance such as Carbapenem and Colistin. In case of a specific resistance, this will be confirmed with additional phenotypic and genotypic tests such as ROSCO disk and polymerase chain reaction (PCR) based panel and whole genome sequencing in order to detect specific resistance mechanisms and genes. Bacteria will be sequenced using Illumina and Nanopore based sequencing. Bioinformatic analysis will allow to determine the whole bacterial genome with containing resistance genes and also describe the microbiota diversity over time in single individuals.
patient questionnaireOther
Each participant will have to provide a questionnaire before and after travelling, as well after 2, 4, 6, 8, 10, 12, 16, 20 and 52 weeks.
examination of blood sampleOther
Each participant will have to provide a blood sample before and after travelling and after 6, 12 and 20 weeks. A serum sample (5mL) for antibody measurement and a 50 ml blood sample for recovery of peripheral blood mononuclear cells (PBMCs in 6 CPTs) for cell mediated immunity will be collected. Serum and PBMCs will allow the analysis of anti-E. coli humoral and cellular responses in order to characterize the individual immune response to specific bacteria over time. Single nucleotide polymorphisms associated with humoral and cellular immune responses will be characterized and linked to immunological and clinical phenotypes and endpoints of the study.
| Study group | Role | What they receive |
|---|---|---|
| travellers to Southeast Asia | Clients planning to travel to Southeast Asia will be recruited Receives: Other: examination of stool sample; Other: patient questionnaire; Other: examination of blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients being "naturally" decolonized from ESBL E. coli
proportion of patients being "naturally" decolonized from ESBL E. coli at the end of the study period at 18 months
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start13 Jun 2019
- Primary completion9 Feb 2020
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extended Spectrum Beta Lactamases (ESBL) E. ColiStudies 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Gebert Rüf-Stiftung
- Responsible party
- Sponsor
- Investigators
- Adrian Egli, PD Dr. med., Principal investigator, Division of Clinical Microbiology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764500
- Sponsor's protocol ID
- 2019-00044; am21Egli
- Other IDs
- 2019
- Status last verified
- Jun 2026
- First submitted
- 17 Feb 2021
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Microbials to Fight Extended-spectrum Beta-lactamase (ESBL)-Producing Escherichia Coli
- ClinicalTrials.gov ID
- NCT04764500
- Acronym / sponsor ID
- 2019-00044; am21Egli
- Keywords
- Antibiotic resistance, pan-sensitive strains (non-ESBL E. coli), multidrug resistant E. coli strains, ESBL E. coli displacement, multidrug resistant Enterobacteriaceae
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Gebert Rüf-Stiftung
- Study start
- 13 Jun 2019 (actual)
- Primary completion
- 9 Feb 2020 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 21 Feb 2021 (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.
This study is to identify and isolate well-defined microbials (non-ESBL E. coli) in an observational setting exploring natural gastrointestinal decolonization of humans colonized with ESBL E. coli.
Detailed description
Antibiotic resistance is a severe threat to contemporary medicine. Effective approaches to fight multi-drug resistant pathogenic bacteria are needed.
This clinical observational study is to investigate whether express extended spectrum beta lactamases (ESBL) E. coli colonizing the human gut can be out-competed by other, ideally pan-sensitive strains (non-ESBL E. coli).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| travellers to Southeast Asia | – | Other: examination of stool sample, Other: patient questionnaire, Other: examination of blood sampleClients planning to travel to Southeast Asia will be recruited |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Clients planning to travel to Southeast Asia will be recruited while receiving pre-travel health advice at the travel clinic of the Swiss Tropical and Public Health Institute in Basel.
Key inclusion criteria (1 listed)
- travelling to Southeast Asia (India, Bhutan, Nepal, Bangladesh, Myanmar, Thailand, Laos, Cambodia, Vietnam) for a maximum of 4 weeks.
Key exclusion criteria (3 listed)
- other travelling destinations than mentioned above
- antibiotic use at the first sampling time
- Participants who are not colonized will serve as a control group for microbiome comparison
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| examination of stool sampleEach participant provides stool samples before and after travelling, after 2, 4, 6, 8, 10, 12, 16, 20 and 52 weeks. Stool samples will be used for isolating both a) ESBL E. coli strains and b) pan-sensitive E. coli strains. Part of the stool sample is stored for isolation of further E. coli clones and microbiota analysis of the isolation of other microbiota strains. All found Enterobacteriaceae will be screened for additional resistance such as Carbapenem and Colistin. In case of a specific resistance, this will be confirmed with additional phenotypic and genotypic tests such as ROSCO disk and polymerase chain reaction (PCR) based panel and whole genome sequencing in order to detect specific resistance mechanisms and genes. Bacteria will be sequenced using Illumina and Nanopore based sequencing. Bioinformatic analysis will allow to determine the whole bacterial genome with containing resistance genes and also describe the microbiota diversity over time in single individuals. | Other | travellers to Southeast Asia |
| patient questionnaireEach participant will have to provide a questionnaire before and after travelling, as well after 2, 4, 6, 8, 10, 12, 16, 20 and 52 weeks. | Other | travellers to Southeast Asia |
| examination of blood sampleEach participant will have to provide a blood sample before and after travelling and after 6, 12 and 20 weeks. A serum sample (5mL) for antibody measurement and a 50 ml blood sample for recovery of peripheral blood mononuclear cells (PBMCs in 6 CPTs) for cell mediated immunity will be collected. Serum and PBMCs will allow the analysis of anti-E. coli humoral and cellular responses in order to characterize the individual immune response to specific bacteria over time. Single nucleotide polymorphisms associated with humoral and cellular immune responses will be characterized and linked to immunological and clinical phenotypes and endpoints of the study. | Other | travellers to Southeast Asia |
Primary outcome
proportion of patients being "naturally" decolonized from ESBL E. coli
Time frame: 18 months
proportion of patients being "naturally" decolonized from ESBL E. coli at the end of the study period at 18 months
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 17 Jun 2026.
Related trials for Extended Spectrum Beta Lactamases (ESBL) E. Coli
Not yet recruitingObservational study
Extended Tricyle Project Indonesia for Extended-spectrum Beta-lactamase Positive Klebsiella Pneumoniae and Escherichia Coli
Carriage of ESBL-positive Escherichia Coli, Carriage of ESBL-positive Klebsiella Pneumoniae
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.
Adrian Egli, PD Dr. med. principal investigator
Division of Clinical Microbiology, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extended Spectrum Beta Lactamases (ESBL) E. Coli, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 1 inclusion and 3 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 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
proportion of patients being "naturally" decolonized from ESBL E. coli (time frame: 18 months). 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 17 Jun 2026.