Dipsticks and Microscopy to Reduce Antibiotic Use in Women's Urinary Tract Infections: a Pilot Trial (MicUTI)
- Conditions
- Cystitis AcuteAntibiotic Resistant InfectionUrinary Tract Infection BacterialUrinary Tract Infection Lower AcuteMedication Adherence
- Interventions
- Diagnostic Test: Point-of-care microscopy and dipstick guided management
- Registration Number
- NCT05667207
- Lead Sponsor
- Wuerzburg University Hospital
- Brief Summary
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.
- Detailed Description
Introduction: Uncomplicated urinary tract infections (UTIs) in women are among the most common infections encountered in primary care after those of the respiratory tract. They are often self-limiting, even though antibiotics are prescribed for almost all women presenting with suggestive clinical features. Efforts directed to tackle antimicrobial resistance led to primary care randomized controlled trials (RCTs) that investigated alternative treatment strategies in these patients. While reducing antibiotic use substantially, none of the experimental treatments showed non-inferiority to antibiotics with respect to clinical outcomes such as symptom duration, symptom burden, and pyelonephritis. Evidence suggests that rapid point-of-care (POC) tests to detect bacteria and erythrocytes in urine at presentation may help primary care clinicians to select women with uncomplicated UTIs (unUTIs) in whom antibiotics can be withheld without affecting clinical outcomes. The aim of this study is to pilot a full-scaled primary care RCT to evaluate the effects of a POC diagnosis and treatment algorithm based on a combination of phase-contrast microscopy and urinary dipsticks on antibiotic use in women with symptoms of an unUTI.
Methods and analysis: MicUTI (Microscopy in UTI) is a pragmatic open-label two -arm parallel pilot cluster-RCT. Twenty general practices affiliated to the Bavarian Practice Based Research Network (BayFoNet) in Germany will be randomly assigned to deliver patient management based on POC-tests (POCTs) or to the usual care arm. Urine samples will be obtained at presentation for POCTs and microbiological analysis. All patients will be followed-up using a self-directed patient diary completed until day 7 from inclusion or until symptom resolution (up to day 14), and through telephone-calls at day 28. An electronic medical record review is performed in case of missing follow-up information.
Primary endpoints are patient enrollment and retention rates. Exploratory endpoints include antibiotic use for UTI at day 28, time to symptom resolution, symptom burden, the number of recurrent and upper UTIs and re-consultations, and diagnostic accuracy (POCTs vs. urine culture as reference standard).
Ethics, data protection and trial registration: The trial will be conducted in accordance to the declaration of Helsinki and the relevant data protection regulations. Institutional review board approval: 109/22-sc (December 16, 2022)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 154
- Women with at least two of dysuria, frequency, urgency, lower abdominal pain or hematuria.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Point-of-care microscopy and dipstick guided management Point-of-care microscopy and dipstick guided management GPs whose practice is allocated to the intervention will have their management guided by POCTs, namely phase-contrast microscopy and urinary dipsticks for all patients consenting for participation.
- Primary Outcome Measures
Name Time Method Recruitment efficacy 6 months (duration of the trial in each study site) Number of participants enrolled per site over 6 months of trial duration
Retention 28 days (duration of the trial for each enrolled patient) Percentage of complete follow-ups over 28 days
- Secondary Outcome Measures
Name Time Method Upper UTIs 28 days Number of upper UTIs within 28 days
Antibiotic doses 28 days Defined daily doses of the prescribed antibiotics per patient with UTI within 28 days
Re-consultations 28 days Number of consultations due to UTI (or symptoms of UTI) within 28 days
Total antibiotic use 28 days Number of antibiotic prescriptions per patient with UTI within 28 days
Inappropriate antibiotic use Day 0 Percentage of patients with symptoms of UTI who were prescribed antibiotics among those with negative urine cultures
Symptom Burden Days 0-14 Total symptom burden on days 0-7 (area under the curve of the UTI-SIQ-8 total symptom score)
Diagnostic accuracy Day 0 Diagnostic accuracy of microscopy +/- dipstick compared to the standard (urine culture)
Immediate and delayed antibiotics Day 0 Number of immediate and delayed antibiotic prescriptions for uncomplicated UTI at initial consultation
Early relapses Days 0-14 Number of early relapses of UTI (days 0-14)
Recurrent urinary tract infections (UTIs) Days 15-28 Number of recurrent UTIs (day 15-28)
Symptom resolution Days 0-7 (or max. 14 if symptoms last longer) Time to symptom resolution defined as a maximum of 1 point in each of the UTI-SIQ-8 items
Trial Locations
- Locations (2)
Stefanie Stark
🇩🇪Erlangen, Germany
University Hospital Würzburg
🇩🇪Würzburg, Germany