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Идёт набор NCT07559318

Post-Emergency Optimization of Antibiotic Therapy for Urinary Tract Infection (UTI)

Наблюдательное Urinary Tract Infections Antiobiotic Stewardship Emerging Infectious Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Adaptation of antibiotics therapy for outpatient urinary infection following emergency care.
Кому может быть актуально
Состояния в реестре: Urinary Tract Infections, Antiobiotic Stewardship, Emerging Infectious Disease. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Post-Emergency Optimization of UTI Antibiotic Therapy: "Fluoroquinolones and Third-Generation Cephalosporins Under the Spotlight"

Обзор

Prospective, multicenter, non-interventional study conducted over 6 months, including patients presenting to the emergency department with suspected urinary tract infection managed as outpatients and discharged with or without empiric antibiotic therapy. Discharge antibiotic prescriptions are reviewed, with subsequent reassessment and optimization of treatment based on urine culture and susceptibility results

Подробное описание

Urinary tract infections are a frequent cause of emergency department visits, accounting for substantial antibiotic use. Data from the OSCOUR (Organisation de la Surveillance Coordonnée des Urgences) network estimate around 5,000 weekly visits. Resistance rates among Enterobacteriaceae in urine samples are particularly high, largely driven by the widespread use of broad-spectrum antibiotics, especially fluoroquinolones, which are commonly prescribed as empiric therapy. Given their potential for serious adverse effects and their strong selective pressure for resistance, stricter control of their use is warranted, yet remains insufficient.

In current emergency practice, conditions such as pyelonephritis or male urinary tract infections are often treated with broad-spectrum antibiotics that are continued even when pathogens are susceptible to narrower agents. De-escalation to narrower-spectrum therapies would help preserve the microbiota and limit resistance.

This study is a prospective, multicenter, non-interventional observational study conducted over 6 months. It includes patients presenting to the emergency department with suspected urinary tract infections managed on an outpatient basis and discharged with or without empiric antibiotic therapy. Antibiotic treatments are reassessed 48 - 72 hours after inclusion by a physician, allowing for patient follow-up and potential modification of the initial prescription based on urine culture and susceptibility results, in accordance with current guidelines.

The study aims to assess the value of this reassessment strategy in improving antimicrobial stewardship for urinary tract infections in emergency settings and to inform future optimization of clinical practices.

Вмешательства

  • Другое Adaptation of antibiotics therapy for outpatient urinary infection following emergency care
    Re assessment of antibiotic therapy at 48 hours based on urine culture results : discontinuation or de-escalation to a narrower-spectrum agent

Первичные конечные точки

  • Assess changes in fluoroquinolone and third-generation cephalosporin prescribing in outpatient urinary tract infections following adjustment based on urine culture and susceptibility results. [Срок оценки: At 48 hours - 72 hours after the patient inclusion]
Вторичные конечные точки (4)
  • Incidence (percentage) of adverse effects associated with antibiotics. [Срок оценки: At 1 month after the consultation in the Emergency department]
  • Incidence (percentage) of antibiotic prescription savings in the Emergency department for outpatient urinary tract infections (cessation of prescription, shortening of treatment duration and/or narrowing of the spectrum) following the intervention [Срок оценки: At 48 hours - 72 hours after the patient inclusion]
  • Assessment of patient satisfaction with medical follow-up via a question asked directly to the patient via a questionnaire (Better if more than 50 percent of patients are satisfied) [Срок оценки: At 1 month after the consultation in the Emergency department]
  • Assessment of patients' knowledge of antibiotic resistance via a question asked directly to the patient via a questionnaire (Better if more than 50 percent of patients are satisfied) [Срок оценки: At 1 month after the consultation in the Emergency department]

Критерии участия

Критерии включения

  • Age 18 years or over
  • Patients presenting at emergency department, with symptoms suggestive of a urinary tract infection suitable for outpatient management (uncomplicated cystitis or cystitis at risk of complications, uncomplicated pyelonephritis or pyelonephritis at risk of complications, male urinary tract infection with or without fever) who have had a urine culture taken

Критерии исключения

  • Refusal to participate in the study
  • Vulnerable person (person under guardianship or trusteeship, minor, person deprived of liberty, person unable to express their refusal)
  • Pregnant women
  • Severe urinary tract infection (sepsis, septic shock or requiring drainage, except for low urinary catheterisation)
  • Hospitalisation for a urinary tract infection or decompensation of another comorbidity
  • Suspected urinary tract infection without a urine culture having been performed

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 3 центра
  • GHSIF — Melun
  • CH St denis — Saint-Denis
  • CHIV — Villeneuve-Saint-Georges

Идентификаторы

NCT: NCT07559318 · REVIU48

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗