Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05667207
Study type Interventional
Source Wuerzburg University Hospital
Contact Peter K. Kurotschka, MD
Phone +49(0)17670882259
Email kurotschka_p@ukw.de
Status Recruiting
Phase N/A
Start date June 15, 2023
Completion date February 1, 2024

See also
  Status Clinical Trial Phase
Completed NCT04709640 - Pilot Study to Improve Medication Management in Older Adults N/A
Completed NCT03257579 - Myocardial Infarction Prescription Duration Adherence Study N/A
Completed NCT05376397 - Testing THRIVE 365 for Black Sexual Minority Men (On The Daily) N/A
Withdrawn NCT03427008 - A Pilot Study of mDOT for Immunosuppressant Adherence in Adult Kidney Transplant Recipients N/A
Completed NCT03805451 - Life Steps for PrEP for Youth N/A
Withdrawn NCT03292393 - Social Norms and Antihypertensive Medication Adherence N/A
Not yet recruiting NCT02876848 - A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study) N/A
Completed NCT02823795 - The Supporting Patient Activation in Transition to Home Intervention N/A
Completed NCT02914730 - Insulin Dosing Practices in Persons With Diabetes on Multiple Daily Injections
Completed NCT02797262 - Measuring and Monitoring Adherence to ART With Pill Ingestible Sensor System N/A
Completed NCT02066935 - Non-adherence to Immunosuppressives in Kidney Transplantation in Brazil Multicenter Study
Completed NCT01934608 - The Effect of Synching Prescription Refills on Adherence N/A
Completed NCT01741311 - Secondary HIV Prevention and Adherence Among HIV-infected Drug Users N/A
Completed NCT01770314 - Study to Test the Efficacy of Online Education to Increase Safe Use of Opioid Medication. Phase 2
Recruiting NCT01105104 - An Enhanced Medication Monitoring Program Phase 1
Withdrawn NCT01430702 - Feasibility of Using a Telemedicine Medication Delivery Unit for Older Adults N/A
Completed NCT01859273 - Adherence Enhancement for Renal Transplant Patients N/A
Completed NCT01118208 - Blister Packaging Medication to Increase Treatment Adherence and Clinical Response N/A
Completed NCT00848224 - Improving Adherence to Pharmacological Treatment N/A
Completed NCT06034301 - Pill Bottle vs Reminder App N/A