Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06307067 |
| Other study ID # |
URINDO |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 4, 2024 |
| Est. completion date |
June 1, 2025 |
Study information
| Verified date |
March 2024 |
| Source |
Erasmus Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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. 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.
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.
