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.
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
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:
- 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.
- 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.
- Conditions
- Urinary Tract Infections
- 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 group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: Urine dipstick |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted12 Mar 2024
- Study start4 Mar 2024 (estimated)
- Primary completion4 Nov 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Saiful Anwar Hospital, Brawijaya University, Malang, Indonesia, Diponegoro University/Diponegoro National Hospital, Semarang, Indonesia, Bali Mandara Hospital, Denpasar, Bali, Indonesia
- Responsible party
- Principal investigator, Juliëtte Severin, Erasmus Medical Center
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Care for Uncomplicated URinary Tract Infection-associated Symptoms in Primary Healthcare Settings in INDOnesia
- ClinicalTrials.gov ID
- NCT06307067
- Acronym / sponsor ID
- URINDO / URINDO
- Conditions
- Urinary Tract Infections
- Keywords
- antimicrobial use, diagnostic test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Saiful Anwar Hospital, Brawijaya University, Malang, Indonesia, Diponegoro University/Diponegoro National Hospital, Semarang, Indonesia, Bali Mandara Hospital, Denpasar, Bali, Indonesia
- Study start
- 4 Mar 2024 (estimated)
- Primary completion
- 4 Nov 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- To analyze the knowledge level of healthcare workers on uncomplicated UTI and prudent antibiotic use in primary health care settings in Indonesia.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-intervention group | – | –patients being treated according to the old method (no dipstick as diagnostic test) |
| Post-intervention group | – | Diagnostic Test: Urine dipstickpatients being treated according to the new method (dipstick as diagnostic test) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that come to a public health center with symptoms of an uncomplicated urinary tract infection
Key inclusion criteria (1 listed)
- All adult patients with uncomplicated urinary tract infection
Key exclusion criteria (1 listed)
- patients who have recurrent episodes of uncomplicated UTI, pregnant women, and patients with recent antibiotic use (any antibiotic use within 3 months before visit)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urine dipstickUrine dipstick is a point of care test that can be performed on the urine in the public health center. | Diagnostic test | Post-intervention group |
Primary outcome
appropriateness of prescriptions for uncomplicated UTI-associated symptoms in the primary health care settings in Indonesia
Time frame: 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.