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A multicenter study into the diarrhea causing bacteria entero-invasive Escherichia coli (EIEC) and Shigella species

Invasive Bacteria E. coli/Shigella Study; a prospective multicenter study into entero-invasive Escherichia coli (EIEC) and Shigella species.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON21567
Enrollment
1100
Registered
2015-12-12
Start date
2016-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastro-enteritis caused by entero-invasive E. coli or Shigella species.

Interventions

The intervention in the IBESS is a noninvasive single survey assessed by telephone for inquiry of epidemiological and clinical data of the patient. In case of a minor, one of the parents or caretakers

Sponsors

Centre for Infectious Disease Research, Diagnostics and Perinatal Screening, National Institute of Public Health and the Environment (RIVM), Bilthoven, The Netherlands ; Certe Laboratory for Infectious Diseases, Groningen, The Netherlands; Molecular Unit, Department of Medical Microbiology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of all ages and sex who are 1) suffering from gastro-enteric complaints, and 2) Shigella or EIEC is detected in their feces sample by a IBESS participating medical microbiological laboratory during routine diagnostic procedures.

Exclusion criteria

Exclusion criteria: None, all patients that meet the inclusion criteria can be inclluded.

Design outcomes

Primary

MeasureTime frame
ƒ{The effects of the different diagnostic laboratory results on patient bound risk factors, incidence, spread, clinical relevance and economic consequences of infection. The severity of disease will be assessed with the use of the Modified Vesikari Scale (MVS), a validated gastroenteritis severity score for use in outpatient settings. ƒ{The effect of certain bacterial strain bound characteristics, both phenotypical and genotypical, on severity and spread of infection. The effects will be calculated with ordinal regression models, except for the effects of genotypical characteristics. For this, a bioinformatics approach is needed, and a pipeline of bioinformatics tools and a statistic approach will be developed during the study.

Secondary

MeasureTime frame
ƒ{ Results of molecular epidemiology: the source and relatedness of Shigella and EIEC strains in the Netherlands. ƒ{ If applicable: recommendations for diagnostics to medical microbiological laboratories in the Netherlands. ƒ{ If applicable: recommendations about improvements of national guidelines for the realization and maintenance of quality management for control of infectious diseases caused by Shigella species or EIEC.

Contacts

Public ContactMaaike J.C. van den Beld

RIVM

IBESS@rivm.nl0031 (0)30 2743454

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)