NCT02698332

Brief Summary

The aim of this study is to investigate the effect of diagnostic algorithm for urinary tract infection (UTI) on appropriate prescribing of antibiotics and use of diagnostics for patients with symptoms of urinary tract infection consulting their general practitioner. 70 general practices participating in an observational study regarding UTI are randomized to either receiving a diagnostic algorithm or not receiving anything additional. The study is observational on the patient level and interventional on the practice level.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,550

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 26, 2016

Status Verified

July 1, 2016

Enrollment Period

3 months

First QC Date

February 23, 2016

Last Update Submit

July 25, 2016

Conditions

Urinary Tract Infection

Outcome Measures

Primary Outcomes (2)

  • Difference in appropriate primary choice of treatment in the two groups.

    3 months

  • Difference in price of point-of-care diagnostics used in the two groups

    3 months

Secondary Outcomes (8)

  • Difference in appropriate final choice of treatment in the two groups.

    3 months

  • Difference in appropriate choice of treatment on the day of consultation (day 1) in the two groups

    3 months

  • Difference in appropriate choice of treatment on the day after consultation (day ) in the two groups

    3 months

  • Difference in correct decision to treat on the day of consultation (day 1) in the two groups

    3 months

  • Difference in correct decision to treat on the day after consultation (day 2) in the two groups

    3 months

  • +3 more secondary outcomes

Other Outcomes (4)

  • Association between use of microscopy and appropriate use of antibiotics on the day of consultation

    3 months

  • Association between use of microscopy and appropriate use of antibiotics on the day after consultation

    3 months

  • Association between use of point-of care culture and appropriate use of antibiotics on the day of consultation

    3 months

  • +1 more other outcomes

Study Arms (2)

Algorithm for UTI

ACTIVE COMPARATOR

Practices in this groups receives a diagnostic algorithm for UTI by post

Device: Algorithm for UTI

Control

NO INTERVENTION

Practices in this group does not receive anything in addition to instructions in the observational registration.

Interventions

Algorithm for UTIDEVICE

The algorithm consists of one sheet of laminated paper with instruction in how to diagnose UTI

Algorithm for UTI

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients presenting in general practice with symptoms of UTI who has not formerly participated in the study.

You may not qualify if:

  • Acute admission to hospital.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Practice Copenhagen Region

Copenhagen, 1014, Denmark

Location

Related Publications (2)

  • Holm A, Siersma V, Cordoba GC. Diagnosis of urinary tract infection based on symptoms: how are likelihood ratios affected by age? a diagnostic accuracy study. BMJ Open. 2021 Jan 8;11(1):e039871. doi: 10.1136/bmjopen-2020-039871.

    PMID: 33419902DERIVED

  • Holm A, Siersma V, Bjerrum L, Cordoba G. Availability of point-of-care culture and microscopy in general practice - does it lead to more appropriate use of antibiotics in patients with suspected urinary tract infection? Eur J Gen Pract. 2020 Dec;26(1):175-181. doi: 10.1080/13814788.2020.1853697.

    PMID: 33356665DERIVED

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Anne Holm, MD

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD-fellow

Study Record Dates

First Submitted

February 23, 2016

First Posted

March 3, 2016

Study Start

March 1, 2016

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

July 26, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)