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Urinary Tract InfectionsURINDONCT06307067

Improving Care for Uncomplicated URinary Tract Infection-associated Symptoms in Primary Healthcare Settings in INDOnesia

An observational study of Urinary Tract Infections, run by Erasmus Medical Center at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urinary Tract Infections
What is being tested?
Urine dipstick
How many people
300 participants
Where
1 siteNetherlands
Study dates
4 Mar 2024to 1 Jun 2025
How long will I take part?
1 Week
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • All adult patients with uncomplicated urinary tract infection

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site
  • Erasmus Medical Center

    Rotterdam, South Holland, 3015 GD

Other trials in Netherlands

About this study

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. 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. To analyze the knowledge level of healthcare workers on uncomplicated UTI and prudent antibiotic use in primary health care settings in Indonesia.
Read the detailed description

Uncomplicated urinary tract infection (UTI) is one of the most frequent diagnoses and reasons for prescribing antibiotics in primary health care, however the laboratory capacity to perform urine cultures in primary health care in Indonesia is limited. Consequently, inappropriate antibiotic prescriptions for uncomplicated UTI patients in the primary health care may occur.

A before-after study will be carried out in primary health care settings in three cities (Malang, Semarang, and Denpasar) in Indonesia.

The specific aims will be addressed as follows:

Aim 1:

The study will be divided into three phases: pre-intervention (3 months) (i.e. in which patients are being treated according to the old method), intervention (1 month) (i.e., wash-in period, HCW will be trained to conduct the urinary dipstick test), and post-intervention (3 months) (i.e. in which for all patients with urinary complaints a dipstick test will be used). Urinary dipstick testing will be introduced as an intervention to rule-out uncomplicated UTI in the primary health care. Urine culture will be performed to confirm the diagnosis of uncomplicated UTI based on the bacterial colony count on the MacConkey agar. Urine specimen will be inoculated on to MacConkey agar and stored in 2-8oC until incubating in the microbiology laboratory of Dr. Saiful Anwar hospital (Malang), Diponegoro National hospital (Semarang), or Bali Mandara hospital (Denpasar). Identification of isolates and antimicrobial susceptibility testing will be performed using Vitek2 (bioMérieux). The urine culture results will not change the decision of antibiotic therapy to the patients.

Qualitative evaluation of antibiotics for uncomplicated UTI in primary health care settings will be performed by the Gyssens' algorithm and subsequent comparison before (pre-intervention) and after urinary dipstick testing (post-intervention) was applied (Hadi U, et al, 2008). All adult patients with uncomplicated UTI are eligible for inclusion in the study. Of each included patient, we will collect the following information after written consent: basic characteristics (e.g., gender, age) and UTI complaints (e.g. dysuria and lower abdominal pain) by structured interview. Participants will provide a clean-catch mid-stream urine for (dipstick test and) culture. However, patients who have recurrent episodes of uncomplicated UTI, pregnant women, and patients with recent antibiotic use (any antibiotic use within 3 months before visit) will be excluded. We will ask patients to return to the same public health center within one week after inclusion if they have the same complains, this will be recorded.

Sample size: 50 patients in each group; this would lead to a total sample size of 300 patients.

Aim 2:

The knowledge on and current practice of uncomplicated UTI management in primary health care settings will be obtained by a survey among HCW in the baseline phase (pre-intervention). The survey will be partly open-ended questions including the number of uncomplicated UTI cases per month (on average), the complaints of patient with uncomplicated UTI, how the healthcare workers decide to treat and not to treat for patients with suspected uncomplicated UTI, what antibiotics the healthcare workers choose and why they choose that kind of antibiotics. General knowledge on antibiotics will also be measured.

Being tested
Urine dipstick
Keywords
antimicrobial use, diagnostic test
Medical subject headings
Urinary Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Urine dipstickDiagnostic test

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

Study groups in NCT06307067
Study groupRoleWhat they receive
Pre-intervention grouppatients being treated according to the old method (no dipstick as diagnostic test)
Post-intervention grouppatients being treated according to the new method (dipstick as diagnostic test)
Receives: Diagnostic Test: Urine dipstick

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 2024

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2024
  2. Study start4 Mar 2024 (estimated)
  3. Primary completion4 Nov 2024 (estimated)
  4. Study completion1 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
300 participants (estimated)
Target duration
1 Week
IDs, dates and publications
ClinicalTrials.gov ID
NCT06307067
Sponsor's protocol ID
URINDO
Acronym
URINDO
Status last verified
Mar 2024
First submitted
6 Mar 2024
Last updated
12 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Urinary Tract Infections, run by Erasmus Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

appropriateness of prescriptions for uncomplicated UTI-associated symptoms in the primary health care settings in Indonesia (time frame: 2024). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.

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