NCT06307067

Brief Summary

In the present study, we aim to analyze the impact of the introduction of a urinary dipstick test for patients presenting with uncomplicated UTI-associated symptoms on antibiotic prescription in primary health care in Indonesia. In addition, the knowledge of HCW regarding antibiotics and prudent use of antibiotics in the community setting will be investigated. Specific aims of the study:

  1. 1.To analyze the quality of antibiotic prescriptions for uncomplicated UTI in the primary health care settings in Indonesia, before introduction of urinary dipstick testing compared to after introduction of urinary dipstick testing.
  2. 2.To analyze the knowledge level of healthcare workers on uncomplicated UTI and prudent antibiotic use in primary health care settings in Indonesia.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Start

First participant enrolled

March 4, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

8 months

First QC Date

March 6, 2024

Last Update Submit

March 6, 2024

Conditions

Keywords

antimicrobial usediagnostic test

Outcome Measures

Primary Outcomes (1)

  • appropriateness of prescriptions for uncomplicated UTI-associated symptoms in the primary health care settings in Indonesia

    2024

Study Arms (2)

Pre-intervention group

patients being treated according to the old method (no dipstick as diagnostic test)

Post-intervention group

patients being treated according to the new method (dipstick as diagnostic test)

Diagnostic Test: Urine dipstick

Interventions

Urine dipstickDIAGNOSTIC_TEST

Urine dipstick is a point of care test that can be performed on the urine in the public health center.

Post-intervention group

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsFemale and male patients will be included, but women suffer more from uncomplicated UTI.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients that come to a public health center with symptoms of an uncomplicated urinary tract infection

You may qualify if:

  • All adult patients with uncomplicated urinary tract infection

You may not qualify if:

  • patients who have recurrent episodes of uncomplicated UTI, pregnant women, and patients with recent antibiotic use (any antibiotic use within 3 months before visit)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

Bacteria from urine culture

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, Medical coordinator Unit infection prevention

Study Record Dates

First Submitted

March 6, 2024

First Posted

March 12, 2024

Study Start

March 4, 2024

Primary Completion

November 4, 2024

Study Completion

June 1, 2025

Last Updated

March 12, 2024

Record last verified: 2024-03

Locations