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| Name | Class |
|---|---|
| Gebert Rüf-Stiftung | UNKNOWN |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| travellers to Southeast Asia | Clients planning to travel to Southeast Asia will be recruited |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Adrian Egli, PD Dr. med. | Division of Clinical Microbiology, University Hospital Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel, Division of Clinical Microbiology | Basel | 4031 | Switzerland |
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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).
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| 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. |
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| 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. |
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| ID | Term |
|---|---|
| D004927 | Escherichia coli Infections |
| ID | Term |
|---|---|
| D004756 | Enterobacteriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000073222 | Patient Health Questionnaire |
| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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