Clinical trial NCT05667207: Dipsticks and Microscopy to Reduce Antibiotic Use in Women's Urinary Tract Infections: a Pilot Trial (MicUTI)
Official title: Dipsticks and Point-of-care Microscopy to Reduce Antibiotic Use in Women With Uncomplicated Urinary Tract Infections: a Cluster-randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystitis Acute
Antibiotic Resistant Infection
Medication Adherence
Urinary Tract Infection Bacterial
Urinary Tract Infection Lower Acute
Keywords: General Practice
Primary care
randomized controlled trial
randomized clinical trial
cluster-randomized trial
pilot study
feasibility
microscopy
urinary dipsticks
clinical decision algorithm
point-of-care test
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital Erlangen
name: LMU Klinikum
name: University of Bristol
name: University of Santiago de Compostela
name: Università degli Studi di Trento
name: University of Wuerzburg
name: University of Georgia
First posted: 2022-12-28
Enrollment: 154
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot study (feasibility)
Primary purpose: OTHER

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)

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment efficacy
timeFrame: 6 months (duration of the trial in each study site)
measure: Retention
timeFrame: 28 days (duration of the trial for each enrolled patient)
Secondary outcomes:
measure: Total antibiotic use
timeFrame: 28 days
measure: Antibiotic doses
timeFrame: 28 days
measure: Inappropriate antibiotic use
timeFrame: Day 0
measure: Immediate and delayed antibiotics
timeFrame: Day 0
measure: Early relapses
timeFrame: Days 0-14
measure: Recurrent urinary tract infections (UTIs)
timeFrame: Days 15-28
measure: Upper UTIs
timeFrame: 28 days
measure: Re-consultations
timeFrame: 28 days
measure: Symptom resolution
timeFrame: Days 0-7 (or max. 14 if symptoms last longer)
measure: Symptom Burden
timeFrame: Days 0-14
measure: Diagnostic accuracy
timeFrame: Day 0
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Stefanie Stark
city: Würzburg
country: Germany
facility: University Hospital Würzburg
Study officials:
affiliation: University Hospital Wuerzburg
name: Ildikó Gágyor, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kurotschka PK, Borgulya G, Bucher E, Endrich I, Figueiras A, Gensichen J, Hay AD, Hapfelmeier A, Kretzschmann C, Kurzai O, Lam TT, Massidda O, Sanftenberg L, Schmiemann G, Schneider A, Simmenroth A, Stark S, Warkentin L, Ebell MH, Gagyor I; Bavarian Practice-Based Research Network (BayFoNet). Dipsticks and point-of-care Microscopy to reduce antibiotic use in women with an uncomplicated Urinary Tract Infection (MicUTI): protocol of a randomised controlled pilot trial in primary care. BMJ Open. 2024 Mar 29;14(3):e079345. doi: 10.1136/bmjopen-2023-079345.