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Clinical Trials/NCT07424989
NCT07424989
Completed
Not Applicable

Antibiotic Therapies for Urinary Tract Infections and Their Impact on the Gut Microbiota

University Hospital, Rouen1 site in 1 country61 target enrollmentStarted: July 4, 2021Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
University Hospital, Rouen
Enrollment
61
Locations
1
Primary Endpoint
Assessing the alteration of the gut microbiota induced by initial antibiotic therapy for urosepsis.

Overview

Brief 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. 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

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University Hospital, Rouen
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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