- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Anna BELKACEM, MD
- Telefonnummer: 01 43 86 21 62
- E-post: anna.belkacem@chiv.fr
Studer Kontakt Backup
- Navn: Wissem TOUADI, Resident
- E-post: wissemtouadi@gmail.com
Studiesteder
-
-
-
Melun, Frankrike
- Har ikke rekruttert ennå
- GHSIF
-
Ta kontakt med:
- De Pontfarcy, MD
-
Saint-Denis, Frankrike
- Har ikke rekruttert ennå
- CH St denis
-
Ta kontakt med:
- SAYRE, MD
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Villeneuve-Saint-Georges, Frankrike
- Rekruttering
- CHIV
-
Ta kontakt med:
- Anna BELKACEM, MD
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Assess changes in fluoroquinolone and third-generation cephalosporin prescribing in outpatient urinary tract infections following adjustment based on urine culture and susceptibility results.
Tidsramme: At 48 hours - 72 hours after the patient inclusion
|
At 48 hours - 72 hours after the patient inclusion
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Incidence (percentage) of adverse effects associated with antibiotics.
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: At 1 month after the consultation in the Emergency department
|
At 1 month after the consultation in the Emergency department
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Patologiske prosesser
- Mannlige urogenitale sykdommer
- Urologiske sykdommer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Sykdomsattributter
- Infeksjoner
- Smittsomme sykdommer
- Patologiske tilstander, tegn og symptomer
- Urinveisinfeksjon
- Smittsomme sykdommer, nye
Andre studie-ID-numre
- REVIU48
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