- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Anna BELKACEM, MD
- Telefonnummer: 01 43 86 21 62
- E-Mail: anna.belkacem@chiv.fr
Studieren Sie die Kontaktsicherung
- Name: Wissem TOUADI, Resident
- E-Mail: wissemtouadi@gmail.com
Studienorte
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Melun, Frankreich
- Noch keine Rekrutierung
- GHSIF
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Kontakt:
- De Pontfarcy, MD
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Saint-Denis, Frankreich
- Noch keine Rekrutierung
- CH St denis
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Kontakt:
- SAYRE, MD
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Villeneuve-Saint-Georges, Frankreich
- Rekrutierung
- CHIV
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Kontakt:
- Anna BELKACEM, MD
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
Suspected of outpatient urinary tract infection
Inclusion of patients with outpatient urinary tract infection in emergency department
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Re assessment of antibiotic therapy at 48 hours based on urine culture results : discontinuation or de-escalation to a narrower-spectrum agent
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Assess changes in fluoroquinolone and third-generation cephalosporin prescribing in outpatient urinary tract infections following adjustment based on urine culture and susceptibility results.
Zeitfenster: At 48 hours - 72 hours after the patient inclusion
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At 48 hours - 72 hours after the patient inclusion
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Incidence (percentage) of adverse effects associated with antibiotics.
Zeitfenster: At 1 month after the consultation in the Emergency department
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At 1 month after the consultation in the Emergency department
|
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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
Zeitfenster: At 48 hours - 72 hours after the patient inclusion
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At 48 hours - 72 hours after the patient inclusion
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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)
Zeitfenster: At 1 month after the consultation in the Emergency department
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At 1 month after the consultation in the Emergency department
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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)
Zeitfenster: At 1 month after the consultation in the Emergency department
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At 1 month after the consultation in the Emergency department
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Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Urogenitale Erkrankungen
- Pathologische Prozesse
- Männliche Urogenitalerkrankungen
- Urologische Erkrankungen
- Weibliche Urogenitalerkrankungen
- Weibliche Urogenitalerkrankungen und Schwangerschaftskomplikationen
- Krankheitsattribute
- Infektionen
- Übertragbare Krankheiten
- Pathologische Zustände, Anzeichen und Symptome
- Harnwegsinfektion
- Übertragbare Krankheiten, Emerging
Andere Studien-ID-Nummern
- REVIU48
Plan für individuelle Teilnehmerdaten (IPD)
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