An interventional study of Point-of-care microscopy and dipstick guided management in Cystitis Acute, Antibiotic Resistant Infection and Medication Adherence, sponsored by Wuerzburg University Hospital. Completed at 2 sites in Germany. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-07-24.
Sponsored by Wuerzburg University Hospital · Not applicable, Interventional, and Other
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.
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)
937 studies on the registry are indexed under Medication Adherence; 159 are open to participants now.
This study's enrollment of 154 is above the median of 120 across 768 interventional studies indexed under Medication Adherence.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Clinically significant
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Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic Test: Point-of-care microscopy and dipstick guided management
Practices in the control arm will not have their management guided by POCTs. They will perform usual care. The treatment decision is usually based on symptoms and dip-stick test results (i.e., erythrocytes, leukocytes, nitrites).
GPs will be encouraged to apply the following diagnosis and treatment algorithm (figure 1) to consenting women, taking their preferences into account: 1. If POCTs are positive for bacteria by microscopy and/or for erythrocytes by dipsticks the GP issues, at his/her own clinical judgement, a delayed or immediate prescription for an antibiotic.10 In the MicUTI intervention, delayed prescription is defined as issuing an antibiotic prescription with the advice to take the medication only when symptoms do not improve or worsen in 48 hours. 2. If POCTs are negative for bacteria and erythrocytes, the GP advises for self-help remedies according to guidelines and to do without antibiotics Study specific training in point-of-care microscopy will be provided to intervention practices.
Recruitment efficacy
Number of participants enrolled per site over 6 months of trial duration
Time frame: 6 months (duration of the trial in each study site)
Retention
Percentage of complete follow-ups over 28 days
Time frame: 28 days (duration of the trial for each enrolled patient)
Total antibiotic use
Number of antibiotic prescriptions per patient with UTI within 28 days
Time frame: 28 days
Antibiotic doses
Defined daily doses of the prescribed antibiotics per patient with UTI within 28 days
Time frame: 28 days
Inappropriate antibiotic use
Percentage of patients with symptoms of UTI who were prescribed antibiotics among those with negative urine cultures
Time frame: Day 0
Immediate and delayed antibiotics
Number of immediate and delayed antibiotic prescriptions for uncomplicated UTI at initial consultation
Time frame: Day 0
Early relapses
Number of early relapses of UTI (days 0-14)
Time frame: Days 0-14
Recurrent urinary tract infections (UTIs)
Number of recurrent UTIs (day 15-28)
Time frame: Days 15-28
Upper UTIs
Number of upper UTIs within 28 days
Time frame: 28 days
Re-consultations
Number of consultations due to UTI (or symptoms of UTI) within 28 days
Time frame: 28 days
Symptom resolution
Time to symptom resolution defined as a maximum of 1 point in each of the UTI-SIQ-8 items
Time frame: Days 0-7 (or max. 14 if symptoms last longer)
Symptom Burden
Total symptom burden on days 0-7 (area under the curve of the UTI-SIQ-8 total symptom score)
Time frame: Days 0-14
Diagnostic accuracy
Diagnostic accuracy of microscopy +/- dipstick compared to the standard (urine culture)
Time frame: Day 0
Plan to share: No
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Wuerzburg University Hospital