Urinary Tract InfectionNCT03577769
Nosocomial Bacteriuria in Geriatric Internal Medicine Services and Follow-up Care and Geriatric Rehabilitation of the Strasbourg University Hospitals
An observational study of Urinary Tract Infection, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
This thesis is a comparative study of the epidemiological characteristics of health-care associated bacteriuria in short and medium term of geriatrics wards in Strasbourg's University Hospital, between 2003 and 2017, in the follow-up of Eric de Pasquale's thesis in 2010. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infection
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2018to Jun 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * patient of age who has been hospitalized in geriatric wards (rehabilitation car service and internal medicine) of Strasbourg's University hospital * date of hospital leaving after 1/1/17 and before 1/1/18 * patient who has a health-care urinary tract infection (occurred more than 48h after admission)
Who may be able to join
- patient of age who has been hospitalized in geriatric wards (rehabilitation car service and internal medicine) of Strasbourg's University hospital
- date of hospital leaving after 1/1/17 and before 1/1/18
- patient who has a health-care urinary tract infection (occurred more than 48h after admission)
- single bacteria in the CBEU
- bacteriuria > 105 cfu/mL regardless which clinical context or bacteria
- if a patient has several bacteriuria, they can be included if they appear after a precedent episode well treated or if the bacteria is different from the precedent
Who cannot join
- participation refusal
- Leaving of hospital out of the inclusion period
- Urinary tract infection which occurred less than 48h after admission (communitarian infection)
- bacteriuria < 105 cfu/mL
- multiple bacteria in the CBEU
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service Geriatrie - Soins de Suite Et Readaptation
Strasbourg, 67091
Catherine JEHL, MD, 33 3 88 11 55 11, catherine.jehl@chru-strasbourg.fr
MARIE ROUSSEL, MD, 33 3 88 11 55 11, marie.nouet@gmail.commarie.roussel@chru-strasbourg.fr
About this study
Official title: Health Care-associated Bacteriuria in Geriatric Wards in Strasbourg's University Hospital : a Comparative Study of Bacterial Ecology Between 2003, 2007 and 2017
This thesis is a comparative study of the epidemiological characteristics of health-care associated bacteriuria in short and medium term of geriatrics wards in Strasbourg's University Hospital, between 2003 and 2017, in the follow-up of Eric de Pasquale's thesis in 2010.
This comparative study will allow to see the evolution of urinary bacterial ecology, bacterial sensitivity to antibiotics, and the part of multi-resistant bacteria, during these 14 years in geriatric services in Strasbourg.
- Conditions
- Urinary Tract Infection
- Keywords
- Health care associated urinary tract infection, Bacteriuria, Elderly, Geriatrics, Antimicrobial resistance, Multi-resistant bacteria
- Medical subject headings
- Urinary Tract Infections, Bacteriuria
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial sensitivity (antibiotic resistance testing)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start1 Jun 2018
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577769
- Sponsor's protocol ID
- 7024
- Status last verified
- Jun 2018
- First submitted
- 21 Jun 2018
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Care-associated Bacteriuria in Geriatric Wards in Strasbourg's University Hospital : a Comparative Study of Bacterial Ecology Between 2003, 2007 and 2017
- ClinicalTrials.gov ID
- NCT03577769
- Acronym / sponsor ID
- 7024
- Conditions
- Urinary Tract Infection
- Keywords
- Health care associated urinary tract infection, Bacteriuria, Elderly, Geriatrics, Antimicrobial resistance, Multi-resistant bacteria
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 5 Jul 2018 (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.
This thesis is a comparative study of the epidemiological characteristics of health-care associated bacteriuria in short and medium term of geriatrics wards in Strasbourg's University Hospital, between 2003 and 2017, in the follow-up of Eric de Pasquale's thesis in 2010.
This comparative study will allow to see the evolution of urinary bacterial ecology, bacterial sensitivity to antibiotics, and the part of multi-resistant bacteria, during these 14 years in geriatric services in Strasbourg.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * patient of age who has been hospitalized in geriatric wards (rehabilitation car service and internal medicine) of Strasbourg's University hospital * date of hospital leaving after 1/1/17 and before 1/1/18 * patient who has a health-care urinary tract infection (occurred more than 48h after admission)
Key inclusion criteria (6 listed)
- patient of age who has been hospitalized in geriatric wards (rehabilitation car service and internal medicine) of Strasbourg's University hospital
- date of hospital leaving after 1/1/17 and before 1/1/18
- patient who has a health-care urinary tract infection (occurred more than 48h after admission)
- single bacteria in the CBEU
- bacteriuria > 105 cfu/mL regardless which clinical context or bacteria
Key exclusion criteria (5 listed)
- participation refusal
- Leaving of hospital out of the inclusion period
- Urinary tract infection which occurred less than 48h after admission (communitarian infection)
- bacteriuria < 105 cfu/mL
- multiple bacteria in the CBEU
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
Bacterial sensitivity (antibiotic resistance testing)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infection, run by University Hospital, Strasbourg, France at 1 site in France.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine JEHL, MD (33 3 88 11 55 11, catherine.jehl@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial sensitivity (antibiotic resistance testing) (time frame: 1 year). 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 5 Jul 2018.