MedTrace Logo

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

NCT04764500 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 39

Last updated 2025-03-03

No results posted yet for this study

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

Interventions

OTHER

examination of stool sample

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.

OTHER

patient questionnaire

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.

OTHER

examination of blood sample

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.

Sponsors & Collaborators

  • Gebert Rüf-Stiftung

    collaborator UNKNOWN

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Adrian Egli, PD Dr. med. · Division of Clinical Microbiology, University Hospital Basel

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-13
Primary Completion
2020-02-09
Completion
2025-12-31

Countries

  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04764500 on ClinicalTrials.gov