## Protocol Section
### Identification Module
**NCT ID:** NCT03206879

**Brief Title:** Fecal ESBL Resurgence During Antibiotic Treatment

**Official Title:** Fecal ESBL Resurgence During Antibiotic Treatment

#### Organization Study ID Info
**ID:** 16-086
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Akershus
### Status Module
#### Completion Date
**Date:** 2018-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-02-06

**Type:** ACTUAL

**Last Update Submit Date:** 2024-02-05

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2018-08

**Type:** ACTUAL

#### Start Date
**Date:** 2016-11

**Type:** ACTUAL

**Status Verified Date:** 2024-02

#### Study First Post Date
**Date:** 2017-07-02
**Type:** ACTUAL
**Study First Submit Date:** 2017-06-30
**Study First Submit QC Date:** 2017-06-30
**Why Stopped:** Several sites did not manage to recruit patients.
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** Sorlandet Hospital HF

**Class:** OTHER_GOV

**Name:** Helse Stavanger HF

**Class:** OTHER_GOV

**Name:** Sykehuset Telemark

**Class:** OTHER

**Name:** Oslo University Hospital

**Class:** OTHER

**Name:** Sykehuset Ostfold

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital, Akershus

#### Responsible Party

**Investigator Affiliation:** University Hospital, Akershus

**Investigator Full Name:** Silje Bakken Jørgensen

**Investigator Title:** Head of section, infection control officer

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### 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.

### Conditions Module

**Conditions:**

- Antibiotic Drug Resistance

**Keywords:**

- ESBL

- Enterobacteriaceae

- multidrug-resistance

### Design Module

#### Bio Spec

**Description:** Bacterial fecal isolates.

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 50

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Measure:** fecal carriage of ESBL-E

**Time Frame:** Baseline

#### Secondary Outcomes

**Measure:** fecal ESBL-E carriage developed during admission

**Time Frame:** Baseline (admission)

### 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.

**Maximum Age:** 120 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Adult, hospitalized patients previously infected by ESBL-E.

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Akershus univversitetssykehus HF

**Name:** Silje B Jørgensen, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4224

- Name: Antibiotics, Antitubercular

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
