Dipsticks and Microscopy to Reduce Antibiotic Use in Women's Urinary Tract Infections: a Pilot Trial (MicUTI)

NCT05667207 | Completed

• 1 other identifier: 109/22-sc
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (11)

• Total antibiotic use

  28 days

• Antibiotic doses

  28 days

• Inappropriate antibiotic use

  Day 0

• Immediate and delayed antibiotics

  Day 0

• Early relapses

  Days 0-14

Study Arms (2)

Point-of-care microscopy and dipstick guided management

EXPERIMENTAL

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

Usual care

NO INTERVENTION

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).

Interventions

Point-of-care microscopy and dipstick guided management DIAGNOSTIC_TEST

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.

Point-of-care microscopy and dipstick guided management

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with at least two of dysuria, frequency, urgency, lower abdominal pain or hematuria.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wuerzburg University Hospital: lead
• University Hospital Erlangen: collaborator
• LMU Klinikum: collaborator
• University of Bristol: collaborator
• University of Santiago de Compostela: collaborator
• Università degli Studi di Trento: collaborator
• University of Wuerzburg: collaborator
• University of Georgia: collaborator

Study Sites (2)

Stefanie Stark

Erlangen, 91054, Germany

Location

University Hospital Würzburg

Würzburg, 97080, Germany

Location

Related Publications (4)

• 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.

  PMID: 38553055 BACKGROUND

• 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.

  PMID: 41060972 DERIVED

• 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.

  PMID: 38166677 DERIVED

• 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.

  PMID: 37438058 DERIVED

Related Links

• Study Protocol

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Ildikó Gágyor, Professor

  University Hospital Wuerzburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot study (feasibility)

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: December 28, 2022
• Study Start: June 15, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: July 24, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)