Antibiotic Drug ResistanceNCT03206879
Fecal ESBL Resurgence During Antibiotic Treatment
An observational study of Antibiotic Drug Resistance, run by University Hospital, Akershus.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Antibiotic Drug Resistance
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult, hospitalized patients previously infected by ESBL-E.
Who may be able to join
- Patients with previous infection or colonization with ESBL-E admitted to one of the participating wards. -
Who cannot join
- Not able to give informed consent.
About this study
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
What is being measured
The primary outcome is the main question the study is designed to answer.
fecal carriage of ESBL-E
Measured: Baseline
Secondary outcomes (1)
fecal ESBL-E carriage developed during admission
Measured: Baseline (admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study startNov 2016
- Primary completionAug 2018
- Study completionDec 2018
Why it stopped: Several sites did not manage to recruit patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic Drug ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- Sorlandet Hospital HF, Helse Stavanger HF, Sykehuset Telemark, Oslo University Hospital, Sykehuset Ostfold
- Responsible party
- Principal investigator, Silje Bakken Jørgensen, University Hospital, Akershus
- Investigators
- Silje B Jørgensen, MD, Principal investigator, Akershus univversitetssykehus HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03206879
- Sponsor's protocol ID
- 16-086
- Status last verified
- Feb 2024
- First submitted
- 30 Jun 2017
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal ESBL Resurgence During Antibiotic Treatment
- ClinicalTrials.gov ID
- NCT03206879
- Acronym / sponsor ID
- 16-086
- Conditions
- Antibiotic Drug Resistance
- Keywords
- ESBL, Enterobacteriaceae, multidrug-resistance
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Several sites did not manage to recruit patients.
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- Sorlandet Hospital HF, Helse Stavanger HF, Sykehuset Telemark, Oslo University Hospital, Sykehuset Ostfold
- Study start
- Nov 2016 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult, hospitalized patients previously infected by ESBL-E.
Key inclusion criteria (1 listed)
- Patients with previous infection or colonization with ESBL-E admitted to one of the participating wards. -
Key exclusion criteria (1 listed)
- Not able to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
fecal carriage of ESBL-E
Time frame: Baseline
1 secondary outcome
fecal ESBL-E carriage developed during admission
Time frame: Baseline (admission)
Results and safety
The study was stopped early (reason given: Several sites did not manage to recruit patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silje B Jørgensen, MD principal investigator
Akershus univversitetssykehus HF
Questions about this trial
What is this clinical trial studying?
An observational study of Antibiotic Drug Resistance, run by University Hospital, Akershus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Several sites did not manage to recruit patients.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fecal carriage of ESBL-E (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.