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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07559318
Post-Emergency Optimization of Antibiotic Therapy for Urinary Tract Infection (UTI) (REVIU48)
Post-Emergency Optimization of UTI Antibiotic Therapy: "Fluoroquinolones and Third-Generation Cephalosporins Under the Spotlight"
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
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Anna BELKACEM, MD
- Número de telefone: 01 43 86 21 62
- E-mail: anna.belkacem@chiv.fr
Estude backup de contato
- Nome: Wissem TOUADI, Resident
- E-mail: wissemtouadi@gmail.com
Locais de estudo
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-
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Melun, França
- Ainda não está recrutando
- GHSIF
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Contato:
- De Pontfarcy, MD
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Saint-Denis, França
- Ainda não está recrutando
- CH St denis
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Contato:
- SAYRE, MD
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Villeneuve-Saint-Georges, França
- Recrutamento
- CHIV
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Contato:
- Anna BELKACEM, MD
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Suspected of outpatient urinary tract infection
Inclusion of patients with outpatient urinary tract infection in emergency department
|
Re assessment of antibiotic therapy at 48 hours based on urine culture results : discontinuation or de-escalation to a narrower-spectrum agent
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Assess changes in fluoroquinolone and third-generation cephalosporin prescribing in outpatient urinary tract infections following adjustment based on urine culture and susceptibility results.
Prazo: At 48 hours - 72 hours after the patient inclusion
|
At 48 hours - 72 hours after the patient inclusion
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Incidence (percentage) of adverse effects associated with antibiotics.
Prazo: At 1 month after the consultation in the Emergency department
|
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
Prazo: At 48 hours - 72 hours after the patient inclusion
|
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)
Prazo: At 1 month after the consultation in the Emergency department
|
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)
Prazo: At 1 month after the consultation in the Emergency department
|
At 1 month after the consultation in the Emergency department
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Processos Patológicos
- Doenças Urogenitais Masculinas
- Doenças Urológicas
- Doenças Urogenitais Femininas
- Doenças urogenitais femininas e complicações na gravidez
- Atributos da doença
- Infecções
- Doenças Transmissíveis
- Condições Patológicas, Sinais e Sintomas
- Infecções do trato urinário
- Doenças Transmissíveis, Emergentes
Outros números de identificação do estudo
- REVIU48
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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