Urinary Tract Infection(UTI)ABIMENCT07424989
Antibiotic Therapies for Urinary Tract Infections and Their Impact on the Gut Microbiota
An observational study of Urinary Tract Infection(UTI), run by University Hospital, Rouen at 1 site in France.
Trial summary
A urinary tract infection requires antibiotic treatment. While this treatment is intended to eliminate bacteria from the urine, it may also facilitate the development of resistant strains in the digestive tract. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infection(UTI)
- How many people
- 61 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jul 2021to 28 May 2025
- 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: Patients will be recruited via the Emergency Department (ED).
Who may be able to join
- Adult patient requiring hospitalisation
- Diagnosis of urinary tract infection requiring systemic antibiotic therapy with ceftriaxone, piperacillin/tazobactam or temocillin
- Collection of a stool sample possible before or within 24 hours of starting systemic antibiotic therapy
- Patient who has read and understood the information letter and given their consent to participate in the research
Who cannot join
- Minor patient
- Patient hospitalised in an intensive care unit
- Digestive stoma
- Patient not affiliated with social security
- Pregnant woman, woman in labour or breastfeeding woman
- Person deprived of liberty by administrative or judicial decision
- Person placed under judicial protection, guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
A urinary tract infection requires antibiotic treatment. While this treatment is intended to eliminate bacteria from the urine, it may also facilitate the development of resistant strains in the digestive tract. Patients are asked to provide stool samples on several occasions so that any potential side effects of this treatment on the digestive flora can be analysed.
Read the detailed description
Each of us has billions of bacteria in our intestines that aid digestion (scientifically known as the gut microbiota), some of which can "mutate", i.e. adapt to resist antibiotics. Although this is usually harmless, these bacteria can sometimes cause infections.
Hence the importance of better understanding this phenomenon, known as the 'collateral effect on flora of otherwise beneficial antibiotic treatment'. The investigators already know that not all antibiotics are equivalent, with some having a stronger 'collateral effect'. However, the risk classification remains poorly understood.
Recent advances in laboratory stool analysis now make it possible to better analyse this phenomenon.
The ultimate goal is to identify treatment regimens that are both highly effective in treating urinary tract infections and have the least possible ecological impact.
- Conditions
- Urinary Tract Infection(UTI)
- Keywords
- systemic antibiotic therapy, urinary tract infection, enteric carriage of EC3GR, stools
- Medical subject headings
- Urinary Tract Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the alteration of the gut microbiota induced by initial antibiotic therapy for urosepsis.
Impact of initial antibiotic therapy on the increase in EC3GR enteric carriage defined as:
- Positive EC3GR culture in stool sample 30-35 days after the end of antibiotic treatment (FT+30-35) in a patient with a negative (i.e. undetectable) EC3GR culture in stool sample on day 0 (D0)
- Or a tenfold increase in the relative abundance of EC3GR between stool samples taken on D0 and FT-30-35 in patients with a positive EC3GR culture in stool samples taken on D0
Measured: From enrollment to 30-35 days after the end of antibiotic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start4 Jul 2021
- Primary completion28 May 2025
- Study completion28 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract Infection(UTI)Studies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424989
- Sponsor's protocol ID
- 2019/329/OB
- Acronym
- ABIME
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 24 Feb 2026
- 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 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Therapies for Urinary Tract Infections and Their Impact on the Gut Microbiota
- ClinicalTrials.gov ID
- NCT07424989
- Acronym / sponsor ID
- ABIME / 2019/329/OB
- Conditions
- Urinary Tract Infection(UTI)
- Keywords
- systemic antibiotic therapy, urinary tract infection, enteric carriage of EC3GR, stools
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 4 Jul 2021 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 28 May 2025 (actual)
- First posted
- 20 Feb 2026 (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.
A urinary tract infection requires antibiotic treatment. While this treatment is intended to eliminate bacteria from the urine, it may also facilitate the development of resistant strains in the digestive tract. Patients are asked to provide stool samples on several occasions so that any potential side effects of this treatment on the digestive flora can be analysed.
Detailed description
Each of us has billions of bacteria in our intestines that aid digestion (scientifically known as the gut microbiota), some of which can "mutate", i.e. adapt to resist antibiotics. Although this is usually harmless, these bacteria can sometimes cause infections.
Hence the importance of better understanding this phenomenon, known as the 'collateral effect on flora of otherwise beneficial antibiotic treatment'. The investigators already know that not all antibiotics are equivalent, with some having a stronger 'collateral effect'. However, the risk classification remains poorly understood.
Recent advances in laboratory stool analysis now make it possible to better analyse this phenomenon.
The ultimate goal is to identify treatment regimens that are both highly effective in treating urinary tract infections and have the least possible ecological impact.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited via the Emergency Department (ED).
Key inclusion criteria (4 listed)
- Adult patient requiring hospitalisation
- Diagnosis of urinary tract infection requiring systemic antibiotic therapy with ceftriaxone, piperacillin/tazobactam or temocillin
- Collection of a stool sample possible before or within 24 hours of starting systemic antibiotic therapy
- Patient who has read and understood the information letter and given their consent to participate in the research
Key exclusion criteria (7 listed)
- Minor patient
- Patient hospitalised in an intensive care unit
- Digestive stoma
- Patient not affiliated with social security
- Pregnant woman, woman in labour or breastfeeding woman
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
Assessing the alteration of the gut microbiota induced by initial antibiotic therapy for urosepsis.
Time frame: From enrollment to 30-35 days after the end of antibiotic treatment
Impact of initial antibiotic therapy on the increase in EC3GR enteric carriage defined as: * Positive EC3GR culture in stool sample 30-35 days after the end of antibiotic treatment (FT+30-35) in a patient with a negative (i.e. undetectable) EC3GR culture in stool sample on day 0 (D0) * Or a tenfold increase in the relative abundance of EC3GR between stool samples taken on D0 and FT-30-35 in patients with a positive EC3GR culture in stool samples taken on D0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Urinary Tract Infection(UTI)
Recruiting
Diagnosis and Treatment of Urinary Tract Infection Using DNA Polymerase Chain Reaction Versus Urine Culture
Urinary Tract Infections
Active, not recruitingObservational study
Clinical Performance Evaluation of the QIAstat-Dx® cUTI Plus AMR
Complicated Urinary Tract Infection
Recruiting
INterest of the Negative Predictive Value of Integrons in the reduCtion of Large Broad-spectrum anTibiotics Consumption for Urinary Tract infectionS
Drug Resistance, Microbial, Biomarkers
Not yet recruitingObservational study
Comparative Study of the Genomic Characteristics of Uropathogenic Escherichia Coli According to the Severity of Community-Acquired Urinary Tract Infections in Guadeloupe (COLIGENURI)
Urinary Tract Infections
Active, not recruitingObservational study
Characterization of Vaginal, Urinary and Fecal Microbiomes in Women With Recurrent Urinary Tract Infections
Urinary Tract Infections, Menopause
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.
The record lists no contact. Use the official record to reach the sponsor.
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(UTI), run by University Hospital, Rouen 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 24 Feb 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessing the alteration of the gut microbiota induced by initial antibiotic therapy for urosepsis. (time frame: From enrollment to 30-35 days after the end of antibiotic treatment). 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 24 Feb 2026.