Fecal ESBL Resurgence During Antibiotic Treatment

NCT03206879 | Terminated

• 1 other identifier: 16-086
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Norwegian hospitals are struggling to control spread of extended-spectrum beta-lactamase producing Enterobacteriaceae (ESBL-E) in health care settings. Strict screening and isolation criteria are enforced in hospital, and patients previously infected by ESBL-E are regarded as possible ESBL-E carriers indefinitely. This observational multi-centre cross-sectional study aims to estimate the duration of fecal ESBL-E carriage and to assess the risk of ESBL-E resurgence during hospital stay for patients previously infected by ESBL-E. Through better knowledge of these risk factors, infection control procedures may be better tailored to rhe individual patient.

Conditions

Antibiotic Drug Resistance

Keywords

ESBL; Enterobacteriaceae; multidrug-resistance

Outcome Measures

Primary Outcomes (1)

• fecal carriage of ESBL-E

  Baseline

Secondary Outcomes (1)

• fecal ESBL-E carriage developed during admission

  Baseline (admission)

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult, hospitalized patients previously infected by ESBL-E.

You may qualify if:

• Patients with previous infection or colonization with ESBL-E admitted to one of the participating wards. -

You may not qualify if:

• Not able to give informed consent.

Sponsors & Collaborators

• University Hospital, Akershus: lead
• Sorlandet Hospital HF: collaborator
• Helse Stavanger HF: collaborator
• Sykehuset Telemark: collaborator
• Oslo University Hospital: collaborator
• Sykehuset Ostfold: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Bacterial fecal isolates.

Study Officials

• Silje B Jørgensen, MD

  Akershus univversitetssykehus HF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of section, infection control officer

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 2, 2017
• Study Start: November 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share