MicUTI
Dipsticks and Point-of-care Microscopy to Reduce Antibiotic Use in Women With Uncomplicated Urinary Tract Infections: a Cluster-randomized Controlled Pilot Trial
Sponsor study identifier
interventional
154
1 country
2
Study Start
June 15, 2023
Actual (reported)Primary Completion
April 30, 2024
Actual (reported)Study Completion
April 30, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 30, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 19, 2022
Actual (reported)December 28, 2022
Actual (reported)June 15, 2023
Actual (reported)April 30, 2024
Actual (reported)April 30, 2024
Actual (reported)Recruitment efficacy
Number of participants enrolled per site over 6 months of trial duration
6 months (duration of the trial in each study site)
Retention
Percentage of complete follow-ups over 28 days
28 days (duration of the trial for each enrolled patient)
Total antibiotic use
28 days
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Stefanie Stark
Erlangen, 91054, Germany
University Hospital Würzburg
Würzburg, 97080, Germany
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.
Kurotschka PK, Koch MJ, Bucher E, Figueiras A, Gensichen J, Hapfelmeier A, Hay AD, Kretzschmann C, Kurzai O, Lam TT, Lasher K, 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 in Urinary Tract Infections in primary care: Results of the MicUTI pilot cluster randomised controlled trial. PLoS One. 2025 Oct 8;20(10):e0332390. doi: 10.1371/journal.pone.0332390. eCollection 2025.
Ildikó Gágyor, Professor
Wuerzburg University Hospital
154 participants (actual enrollment reported by the registry).
First Submitted
December 19, 2022
First Posted
December 28, 2022
Study Start
June 15, 2023
Actual (reported)Antibiotic doses
28 days
Inappropriate antibiotic use
Day 0
Immediate and delayed antibiotics
Day 0
Early relapses
Days 0-14
Contact the study team to confirm eligibility.
Sanftenberg L, Schnaidt AL, Eck S, Schneider A, Bucher E, Kurotschka PK, Gagyor I, Klanke M, Stark S, Kuhlein T, Walter F, Roos M, Dreischulte T, Gensichen J; BayFoNet study group. Experiences of general practice teams and their patients with clinical research-a mixed-methods process evaluation of the Bavarian Research Practice Network (BayFoNet). BMC Prim Care. 2025 Feb 28;26(1):59. doi: 10.1186/s12875-025-02744-x.
Sanftenberg L, Stofella J, Mayr K, Nassehi A, Hardtlein A, Stark S, Kuhlein T, Kurotschka PK, Gagyor I, Eck S, Schneider A, Bossenecker M, Roos M, Dreischulte T, Gensichen J; BayFoNet study group. Expectations of general practitioners on a practice based research network in Germany- a qualitative study within the Bavarian Research Practice Network (BayFoNet). BMC Prim Care. 2024 Jan 2;25(1):10. doi: 10.1186/s12875-023-02239-7.
Sanftenberg L, Dreischulte T, Hardtlein A, Kosub H, Gagyor I, Kurotschka PK, Kuhlein T, Burggraf L, Eck S, Roos M, Gensichen J; BayFoNet-Research-Group. Process evaluation in practice based research networks: a study protocol for a mixed-methods implementation study. BMJ Open. 2023 Jul 12;13(7):e065947. doi: 10.1136/bmjopen-2022-065947.
Primary Completion
April 30, 2024
Actual (reported)Study Completion
April 30, 2024
Actual (reported)Last Updated
July 24, 2024
Record last verified: 2023-11
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Source: ClinicalTrials.gov.
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