Developing Microbials to Fight Extended-spectrum Beta-lactamase (ESBL)-Producing Escherichia Coli

NCT04764500 | Active Not Recruiting

• 1 other identifier: 2019-00044; am21Egli
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Extended Spectrum Beta Lactamases (ESBL) E. Coli

Keywords

Antibiotic resistance; pan-sensitive strains (non-ESBL E. coli); multidrug resistant E. coli strains; ESBL E. coli displacement; multidrug resistant Enterobacteriaceae

Outcome Measures

Primary Outcomes (1)

• 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

  18 months

Study Arms (1)

travellers to Southeast Asia

Clients planning to travel to Southeast Asia will be recruited

Other: examination of stool sample; Other: patient questionnaire; Other: examination of blood sample

Interventions

examination of stool sample OTHER

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.

travellers to Southeast Asia

patient questionnaire OTHER

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.

travellers to Southeast Asia

examination of blood sample OTHER

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.

travellers to Southeast Asia

Eligibility Criteria

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

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.

You may qualify if:

• travelling to Southeast Asia (India, Bhutan, Nepal, Bangladesh, Myanmar, Thailand, Laos, Cambodia, Vietnam) for a maximum of 4 weeks.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Gebert Rüf-Stiftung: collaborator

Study Sites (1)

University Hospital Basel, Division of Clinical Microbiology

Basel, 4031, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bacterial isolates and -80°C stool samples. Serum samples and blood cells may be used for antibody analysis and blood cell analysis (incl. B-cell immortalization for monoclonal antibody generation).

MeSH Terms

Conditions

Escherichia coli Infections

Interventions

Patient Health Questionnaire

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Psychological Tests; Behavioral Disciplines and Activities; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Adrian Egli, PD Dr. med.

  Division of Clinical Microbiology, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 21, 2021
• Study Start: June 13, 2019
• Primary Completion: February 9, 2020
• Study Completion: December 1, 2025
• Last Updated: March 3, 2025

Record last verified: 2025-02

Locations

CH (1)