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OpenTrials
Completed

NCT Number: NCT07424989

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Rouen

Rouen, 76031, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: ABIME

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Feb 20, 2026
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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