N30.0 N39.0 N10
Conditions
Interventions
Group 1: Usual care group
Standard care following discharge from the emergency department for a urinary tract infection, including routine clinical follow-up and study-specific follow-up on days 14 an
Sponsors
Universitätsklinikum Essen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age: = 18 years. 2. Care setting: Presentation at the central emergency department (CED) with planned outpatient discharge (no initial inpatient admission). 3. Clinical suspicion of urinary tract infection (UTI): - Uncomplicated UTI: typical symptoms (e.g., dysuria, pollakiuria, urgent urge to urinate) without signs of pyelonephritis/sepsis. - Catheter-associated UTI: Indwelling catheter with corresponding local/systemic symptoms. - Complicated UTI (manageable on an outpatient basis): Clinical presentation in which outpatient therapy is deemed appropriate based on the physician’s assessment. 4. Capacity to consent: Ability and willingness to provide informed consent to study participation and data processing. 5. App requirements: - Personal smartphone (iOS/Android) - Ability to install the app and regular access to the internet - Willingness to answer the app’s questions through at least Day 7. 6. Contactability: Availability via phone or email for follow-up questions and consent to app notifications.
Exclusion criteria
Exclusion criteria: 1. Outpatient management is not possible: Hospital admission, intravenous therapy, or mandatory monitoring are required for clinical reasons. 2. Inability to give consent or inability to provide informed consent (including acute confusion, cognitive impairment without a legal representative). 3. Recent urological surgery/trauma or other acute conditions that significantly impact diagnosis, treatment, and follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. AAM-72 (Appropriate Antibiotic Management at 72 hours) Definition: The proportion of patients who are receiving guideline-appropriate care 72 hours after discharge: (a) no antibiotics in the absence of an indication, or (b) de-escalation to the narrowest effective agent for susceptible isolates, or (c) escalation to an in vitro active agent in cases of resistance, and (d) correct dose/duration according to local guidelines; with no clinical deterioration by day 7. Measurement time/source: 72 h ±12 h after discharge; app/EHR documentation, LIS (culture/resistance), prescription data. 2. DOT-7 (Days of Therapy up to Day 7) Definition: Total number of systemic antibiotic days per patient within 7 days after discharge (calendar day-based; combinations additive). Source: Prescription/dispensing data, EHR, app medication log. 3. TTAT resistance (Time-to-Appropriate Therapy for resistant isolates) Definition: Time (hours) from available culture/resistance results in the LIS to the first active (in vitro effective) therapy. Population: Subgroup with a relevant resistant pathogen. 4. 30-day safety composite – co-primary safety endpoint Definition: Recontact/re-presentation (ZNA), hospitalization, pyelonephritis, sepsis, or death by day 30. Objective: Non-inferiority vs. usual care (predefined margin). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient satisfaction/usability (Likert/NRS), ePRO compliance (% of days with complete app entries). 2. Assessment of antibiotic-associated adverse effects 3. Exploratory (for established systems): Reduction in treatment duration in subgroups (uncomplicated/catheter-associated/complicated) without compromising safety. | — |
Countries
Germany
Contacts
Public ContactLukas van de Sand
Universitätsklinikum Essen
Outcome results
None listed