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

NCT05667207 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2024-07-24

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Point-of-care microscopy and dipstick guided management

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.

Sponsors & Collaborators

  • University Hospital Erlangen

    collaborator OTHER
  • LMU Klinikum

    collaborator OTHER
  • University of Bristol

    collaborator OTHER
  • University of Santiago de Compostela

    collaborator OTHER
  • Università degli Studi di Trento

    collaborator OTHER
  • University of Wuerzburg

    collaborator OTHER
  • University of Georgia

    collaborator OTHER
  • Wuerzburg University Hospital

    lead OTHER

Principal Investigators

  • Ildikó Gágyor, Professor · University Hospital Wuerzburg

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-15
Primary Completion
2024-04-30
Completion
2024-04-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05667207 on ClinicalTrials.gov