Medication Adherence Clinical Trial
— MicUTIOfficial title:
Dipsticks and Point-of-care Microscopy to Reduce Antibiotic Use in Women With Uncomplicated Urinary Tract Infections: a Cluster-randomized Controlled Pilot Trial
With the aim to pilot a full-scaled trial to reduce unnecessary antibiotics in women with suspected uncomplicated urinary tract infections, twenty general practices in Bavaria, Germany, will be randomized to deliver patient management based on phase-contrast microscopy and urinary dipsticks or to usual care. Primary endpoints are recruitment and retention rates.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | February 1, 2024 |
Est. primary completion date | February 1, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Women with at least two of dysuria, frequency, urgency, lower abdominal pain or hematuria. Exclusion Criteria: - Signs of a complicated UTI (anamnesis of fever, chills or flank pain) - Clinically relevant immunosuppression (i.e., current use of any immunosup-pressive therapy, congenital or acquired disorders of immunity) - Acute or chronic functional or anatomical variations in urinary tract except renal insufficiency grade II/IIIa - Permanent bladder catheter or use of bladder catheter within the past two weeks - UTI within the past two weeks - Use of any antibiotic within the past two weeks - Accommodation in a nursing home or hospital stay within the past two weeks - Severe neurologic or psychiatric illness, severe dementia or severe substance use disorder - Other severe diseases - Being unable to understand the informed consent or to complete the patient diary - Known pregnancy |
Country | Name | City | State |
---|---|---|---|
Germany | Stefanie Stark | Erlangen | |
Germany | University Hospital Würzburg | Würzburg |
Lead Sponsor | Collaborator |
---|---|
Wuerzburg University Hospital | LMU Klinikum, Università degli Studi di Trento, University Hospital Erlangen, University of Bristol, University of Georgia, University of Santiago de Compostela, University of Wuerzburg |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recruitment efficacy | Number of participants enrolled per site over 6 months of trial duration | 6 months (duration of the trial in each study site) | |
Primary | Retention | Percentage of complete follow-ups over 28 days | 28 days (duration of the trial for each enrolled patient) | |
Secondary | Total antibiotic use | Number of antibiotic prescriptions per patient with UTI within 28 days | 28 days | |
Secondary | Antibiotic doses | Defined daily doses of the prescribed antibiotics per patient with UTI within 28 days | 28 days | |
Secondary | Inappropriate antibiotic use | Percentage of patients with symptoms of UTI who were prescribed antibiotics among those with negative urine cultures | Day 0 | |
Secondary | Immediate and delayed antibiotics | Number of immediate and delayed antibiotic prescriptions for uncomplicated UTI at initial consultation | Day 0 | |
Secondary | Early relapses | Number of early relapses of UTI (days 0-14) | Days 0-14 | |
Secondary | Recurrent urinary tract infections (UTIs) | Number of recurrent UTIs (day 15-28) | Days 15-28 | |
Secondary | Upper UTIs | Number of upper UTIs within 28 days | 28 days | |
Secondary | Re-consultations | Number of consultations due to UTI (or symptoms of UTI) within 28 days | 28 days | |
Secondary | Symptom resolution | Time to symptom resolution defined as a maximum of 1 point in each of the UTI-SIQ-8 items | Days 0-7 (or max. 14 if symptoms last longer) | |
Secondary | Symptom Burden | Total symptom burden on days 0-7 (area under the curve of the UTI-SIQ-8 total symptom score) | Days 0-14 | |
Secondary | Diagnostic accuracy | Diagnostic accuracy of microscopy +/- dipstick compared to the standard (urine culture) | Day 0 |
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