Fecal ESBL Resurgence During Antibiotic Treatment | NCT03206879

Studies
Fecal ESBL Resurgence During Antibiotic Treatment

NCT03206879

Sponsor

University Hospital, Akershus

Status

Terminated

Last Update Posted

Feb 6, 2024Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Antibiotic Drug Resistance

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Several sites did not manage to recruit patients.

Expanded Access Info

Start Date

Nov 2016Actual

Primary Completion Date

Aug 2018Actual

Completion Date

Dec 2018Actual

First Submitted Date

Jun 30, 2017

First Submission Date that Met QC Criteria

Jun 30, 2017

First Posted Date

Jul 2, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2024

Last Update Posted Date

Feb 6, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Silje Bakken Jørgensen, Head of section, infection control officer, University Hospital, AkershusPrincipal Investigator

Lead Sponsor

University Hospital, AkershusOTHER

Collaborators

Name	Class
Sorlandet Hospital HF	OTHER_GOV
Helse Stavanger HF	OTHER_GOV
Sykehuset Telemark	OTHER_GOV
Oslo University Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
fecal carriage of ESBL-E		Baseline

Secondary Outcomes

Measure	Description	Time Frame
fecal ESBL-E carriage developed during admission		Baseline (admission)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Not able to give informed consent.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

120 Years

Standard Ages

AdultOlder Adult

Study Population

Adult, hospitalized patients previously infected by ESBL-E.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Silje B Jørgensen, MD	Akershus univversitetssykehus HF	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided