Management of suspected urinary tract infection: real-world clinical practice in Spain

INTRODUCTION

Urinary tract infection (UTI) is defined as bacterial growth in the urinary tract associated with compatible signs or symptoms.¹ It is one of the most common bacterial infections in children. Approximately 1.7% of boys and 8.4% of girls will experience at least one episode in the first 7 years of life,² although its reported incidence varies depending on age, sex, ethnicity, clinical presentation (febrile and afebrile), and the criteria used for diagnosis.^1-5 In boys, it is most frequent in the first 3 to 6 months post birth, while in girls, 80% of cases occur from age 1 year. The risk of UTI varies between 2% and 20% in infants aged less than 2 months with fever of unknown origin (FUO), and it can reach 8% in school-aged children presenting with fever or urinary symptoms.¹

Recurrence is common, especially in the 3 to 6 months following the first episode. In the first 12 months of life, 18% of boys and 26% of girls experience recurrence. From this age, recurrences are rare in boys, but they may continue to occur in 40% to 60% of girls.⁵

Some of the risk factors for UTI are: congenital anomalies of the kidney and/or urinary tract, conditions resulting in slowed urine flow, vesicoureteral reflux, phimosis in male infants and adhesions in girls, voiding dysfunction with constipation, neurogenic bladder, urinary catheterization, nephrolithiasis, and sexual activity in adolescent girls.

Diagnosis of a UTI typically leads to antibiotic prescribing (often empiric and usually broad-spectrum) to either treat a current episode or to prevent recurrence, if indicated. It may also prompt imaging studies, as the presence of urinary tract malformations is associated with an increased risk of UTI and recurrent UTI. Febrile UTI may cause acute kidney injury in up to 60% of cases, and the risk of renal scarring ranges between 10% and 15%.¹

While the diagnosis and treatment of UTI vary widely,⁶ there are well-established principles that should be applied in clinical practice. To our knowledge, there are no recent studies on the management of suspected UTI in Spain. The aim of our study was to describe current real-world  clinical practice in the management of UTIs and identify areas of improvement.

PATIENTS AND METHODS

We conducted a nationwide multicenter prospective, longitudinal, observational, and descriptive study in primary care (PC) centers between October 2019 and December 2020. The providers that collaborated in the study were recruited through an invitation distributed to the members of the Spanish Association of Primary Care Pediatrics (AEPap) and the PEDIAP mailing list (of the RedIRIS network), which had 4009 members and 1020 subscribers, respectively, at the time of enrolment.

A total of 206 providers from 16 autonomous communities (ACs) in Spain collaborated in the study, with the highest representation corresponding to the Community of Madrid and Castilla y León (accounting for 34.8% and 20.5% of reported episodes, respectively), followed by Galicia (10.6%) and Andalusia (6.6%). There were no contributors from Murcia, Ceuta, or Melilla. All participating providers worked in the public health system, and 73.2% worked in urban settings. The mean provider caseload was of 1038 patients (median: 1007), which added up to a total of 213 799 patients.

Inclusion criteria: children aged 0 to 15 years assigned to the caseloads of participating providers, in whom UTI (febrile or afebrile) was suspected at some point during the study period, regardless of the care setting in which initial care was provided for the suspected episode, and seen at the PC center at some point during the diagnosis, treatment or follow-up of the episode.

Exclusion criteria: episodes in patients not assigned to the provider’s caseload, who could not be followed up, or absence of informed consent.

We calculated a minimum sample size of 114 patients based on an expected prevalence of UTI of 8% for a 95% confidence level and a maximum margin of error of 5%. The final target sample size was set at 135 patients, considering the expected proportions of exclusions and losses to follow-up.

The data were anonymized and collected in a Google form.

We collected data on demographic and baseline characteristics (age, sex, fever [axillary temperature >38 °C], risk factors, antibiotic use in the previous month, antibiotic prophylaxis); clinical and laboratory variables (symptoms, diagnostic tests performed, urinalysis parameters); and outcome variables (drug [with time to initiation and duration of treatment], imaging tests, and patient outcomes). The risk factors considered in the analysis were vesicoureteral reflux, kidney disease, renal malformation, urinary catheterization, bladder dysfunction, constipation, phimosis, labial adhesions, previous history of UTI, and hypercalciuria.

When the diagnostic evaluation was complete, the provider who reported the case classified it, based on their judgment and expertise, as confirmed UTI (cUTI) or unconfirmed suspected UTI (usUTI).

Statistical analysis: performed with the software JASP, version 0.95.4. Quantitative data were summarized as mean and standard deviation (SD). Qualitative data were summarized as absolute frequencies and percentages. The normality of the distributions was assessed with the Shapiro-Wilk test. Categorical variables were compared using the Fisher exact test; in cases where expected frequencies allowed an adequate asymptotic approximation, we used the Pearson chi-square test. To compare quantitative variables in two independent groups, as the data did not follow a normal distribution, we used the nonparametric Mann-Whitney U test. We considered p-values <0.05 to be statistically significant.

Ethical considerations: The study adhered to the principles of the Declaration of Helsinki and was approved by the Ethics Committee of the Hospital de Fuenlabrada in Madrid (APR 19/03). Patients were included after obtaining informed consent from their parents/legal guardians and, in the case of patients aged 12 years or older, the assent of the patient.

RESULTS

A total of 1506 records were submitted, of which 1402 were valid for the analysis. At the conclusion of the diagnostic evaluation, participating providers classified 763 episodes as cUTI cases and 639 as usUTI cases (Figure 1). Table 1 summarizes the characteristics of the episodes.

Clinical presentation

The most commonly reported symptoms were: in children under 2 years of age, fever, irritability, and loss of appetite (fever and weight loss were significantly more frequent in the usUTI group, and diarrhea in the cUTI group); in children aged more than 2 years, dysuria, frequent urination, and abdominal pain (polyuria and changes in urine were significantly more common in the usUTI group). Table 2 presents the most frequently reported symptoms in the three diagnostic categories, broken down by age (less than 2 years, 2 years or older).

In the subset of children aged less than 2 years presenting with a single symptom, the most frequent symptoms were fever (24%); weight faltering (4%); vomiting (2.9%); and irritability (2%). In the group aged 2 or more years, fever was reported in 1.6% of cases, and irritability in one case.

Diagnosis

In the overall sample of suspected episodes, the patient was asymptomatic in 6 cases. Additional testing was performed in 1385 episodes (98.8%). Urine culture (UC) was performed in 1044 episodes of suspected UTI (74.5%), of which 661 (86.6%) were eventually classified as cUTI and 383 (59.9%) as usUTI. In 267 cases (19%), the only test performed was the dipstick test.

In the group of children who were incontinent due to age, samples for UC were obtained through urinary catheterization or suprapubic aspiration (SPA) in 226 (43.6%).

Among the 763 episodes classified as UTIs by providers, 0.6% were missing clinical data, while only symptoms were documented in 1.2%, without performance of diagnostic tests. In 661 (86.6%), clinical data and UC results were available, and in 66 (8.6%), dipstick results were available, but not results for urinalysis or UC.

In the subset of episodes in incontinent patients classified as UTIs, clinical data were documented and UC samples obtained via catheterization or suprapubic aspiration in 152 (51.7%) patients, while in 71 (24.1%) patients, samples for UC were obtained with a urine collection bag.

Table 3 summarizes the rest of the diagnostics tests performed in the sample.

Table 4 presents the abnormal findings of urinalysis and the UC colony counts in episodes of cUTI.

The dipstick tests and urinalysis results were available immediately in 85% of the episodes in which they were performed, and urine sediment results within 48 hours in 69.7% out of 456 episodes. The results of urine culture (performed in 894 episodes) were available within 24 hours in 7.7% of cases; in 48 to 72 hours in 53.5%; and past 72 hours in the remaining 38.5%.

Treatment

Empirical Antibiotherapy was initiated in 66.7% of the total ITU episodes (88.5% of cUTI episodes and 40.7% of usUTI episodes). The most frequently prescribed antimicrobials were third-generation cephalosporins, fosfomycin trometamol, cefuroxime and amoxicillin-clavulanic acid. Table 5 presents data concerning the time elapsed to treatment initiation, treatment duration, and collection of urine samples for culture prior to initiation for each of the groups.

Of the 256 prescriptions for fosfomycin (for either empiric or targeted antibiotic treatment), 83.6% were for patients aged 12 years or younger. Of the 191 episodes treated with fosfomycin trometamol, 34% involved administration of two doses of the drug.

None of the prescriptions for nitrofurantoin were for male patients.

The antibiotic that was initially prescribed was switched in 135 cases (14.4%), in 73 (54%) after the results of antimicrobial susceptibility testing became available.

Outcomes

In 83.6% of suspected episodes of ITU, the provider considered that the infection had resolved at the time treatment was completed (94% of cases in the cUTI group and 66.7% in the usUTI group). In 5.4% of cases, the provider considered that symptoms persisted (5.8% in the cUTI group and 5.1% in the usUTI group). In 4.6% of cases, according to the provider, the symptoms had resolved spontaneously, without treatment (0.1% of cases in the cUTI group and 11.9% in the usUTI group).

Urine cultures were ordered for follow-up in 255 of the 1402 total cases (18.2%): 4.8% of cases in the usUTI group, and 29.4% in the cUTI group.

In 39 suspected UTI episodes (2.8%), patients had previously received antimicrobial prophylaxis. Table 1 presents the drugs used for prophylaxis in these patients. In addition, during the study period, prophylaxis was initiated in 28 episodes, all in the cUTI group, and this intervention was significantly associated with the presence of fever. Table 6 presents the drugs prescribed for prophylaxis after the UTI episode.

Tests were performed more frequently in febrile patients compared to afebrile patients (χ² = 94.95; p <0.001). There was a similar trend in the ordering of DMSA renal scans ([χ² = 31,74; p <0,001] and voiding cystourethrography [χ² = 16.99; p = 0.017]).

Table 6 presents the results regarding hospital admissions, referral to specialty care, patient outcomes and resolution of UTI, and additional diagnostic tests.

DISCUSSION

This study, conducted in the primary care setting, contributes data on the diagnostic and therapeutic approach to suspected UTI in real-world pediatric practice, identifying areas of improvement. It started right after the publication in Spain of the recommendations for the diagnosis and treatment of urinary tract infection.⁷ These recommendations were followed by the publication of the pediatric urinary tract infection protocol of the Spanish Association of Pediatrics (AEP)¹ and, more recently, the update of the clinical practice guidelines for UTI.⁵ Although some aspects of the management of UTIs are still under debate, ^4-6 there are others for which there is unanimous consensus, ^1,5,7-10 in spite of which there is evidence of widespread nonadherence and considerable heterogeneity in clinical practice.^11-13 The diagnosis of UTI and its differentiation from asymptomatic bacteriuria require the presence of compatible clinical manifestations in addition to a positive urine culture. In this case series, most episodes were symptomatic and UTI was largely suspected based on the presence of several signs or symptoms, in accordance with current recommendations.¹⁴ None of the most frequent symptoms appeared to be significant in isolation, with the exception of fever in children aged less than 2 years. Therefore, UTI should be ruled out in any child aged less than 24 months presenting with FUO.¹⁵

The diagnosis of UTI requires microbiological identification of a uropathogen in a urine sample collected before initiation of antibiotic treatment with a method appropriate for the patient’s age and continence: midstream clean catch urine in continent children and urinary catheterization or SPA in incontinent patients.¹⁶ In spite of this, UTI is frequently diagnosed and treatment prescribed without performance of urine culture or results obtained with specimens collected through urine bags in incontinent patients, ^11,12 a technique that is not recommended due to the high risk of contamination and false-positive rates.^16-18 In our study, urine cultures were not performed in one-quarter of suspected cases, and 13.4% of episodes were considered confirmed without performance of urine culture.  In a small percentage of cases, the reference laboratory reported the urine culture as positive without specifying the colony count, even though, according to the current literature, quantification is essential for adequate interpretation and clinical decision-making.

In 16% of suspected episodes, empiric therapy was initiated without prior collection of a sample for UC (26% of those cases were ultimately not classified as UTIs). In one-quarter of the cases involving patients incontinent due to age in whom providers considered the UTI confirmed, the diagnosis was based on the clinical presentation and the results of UC in specimens obtained through a urine collection bag. Misdiagnosis can lead to inappropriate treatment and further unnecessary testing.

When a UTI is suspected, early initiation of antibiotic treatment is customary. In our study, antibiotics were prescribed in 66.7% of episodes, a proportion lower than reported in other published studies, particularly in the usUTI group (40.7%).¹⁹ In most cases (77.8%), empiric therapy was initiated immediately upon suspicion, probably to avoid complications resulting from delayed initiation, especially in febrile episodes.²⁰ It may also have been due to the delay in receiving  culture results, which was longer than 72 hours in 38% of cases and between 48 and 72 hours in 53.5% of cases. Overall, the turnaround time was shorter than previously reported,²¹ but still far from adequate, as negative cultures should be reported (and the results made available to the provider) within 24 hours. Another factor that may have been at play is the fact that in 18.3% of suspected episodes, the visit to PC took place more than 3 days after onset, and only 41.1% of patients visited the PC center  in the first 24 hours. Although current guidelines recommend shorter courses of treatment for uncomplicated UTI,^5,8,22 previous studies have found durations of 10 days or longer in up to 47.6% of cases of UTI.²³ In our study, the mean duration exceeded recommendations for both febrile and afebrile UTI (8.5 and 6.9 days, respectively). This could also be explained by the prolonged turnaround times for UC.

The selection of antimicrobials reported in our case series was appropriate based on the published etiology and antimicrobial resistance data in Spain,^24-27 although antibiotic selection should be based on local resistance patterns.⁵ Recurring shortages of cefuroxime axetil may have contributed to third-generation cephalosporins being the most frequently prescribed antimicrobials. The second most frequently prescribed drug was fosfomycin trometamol. Of the total prescriptions (empirical and targeted) for fosfomycin, 83.6% were for children aged 12 years or younger. According to the alert issued by the European Medicines Agency in 2020²⁸ and the subsequent modification of the summary of product characteristics, these prescriptions would currently be considered off label. In 34% of the cases treated with fosfomycin trometamol, two doses were prescribed, even though the guidelines recommend a single dose; in other words, there was overtreatment.

Notably, there were four cases in which, despite being classified as UTIs, no treatment was prescribed, which carries a risk of progression and/or complications.

Nitrofurantoin was not prescribed for treatment to any male patients, in compliance with the summary of product characteristics, however, it was used off label for prophylaxis in one boy.

In our study, most episodes were managed on an outpatient basis; 9.3% required hospitalization, with a higher proportion of admission (15.1%) in the group of episodes diagnosed as UTI. An overall hospitalization rate of approximately 27% has been reported, with higher rates of up to 89% in infants aged less than 2 months and lower rates of around 15% in children aged 2 to 24 months, which between hospitals in the range of 6% to 64%.²⁹ Eight percent of cases were referred to hospital-based specialists, a lower proportion compared to the subset of patients who were already in follow-up, with proportions of referral of 2% in the usUTI group and 13% in the cUTI group. These figures may be related to the lack of access to certain tests from PC. The proportion of patients in each diagnostic category that were already in follow-up at the time of the episode was 9.2%, 4.7%, and 13%, respectively.

At this time, performance of follow-up UCs is not recommended for cases with favorable outcomes.¹⁶ In our study, follow-up UCs were ordered in slightly less than 20% of suspected episodes and in nearly 30% of cUTI cases, even though in the latter group, providers considered the outcome be favorable in 94% of cases. This practice could lead to overdiagnosis of new episodes of UTI and increased intervention, additional health care costs, in addition to the risk of iatrogenic complications.

After a UTI is diagnosed, imaging studies may be ordered to detect predisposing structural abnormalities and/or complications or sequelae of the infection, although it is unclear that their findings lead to changes in management or outcomes.⁵ At present, the most frequently ordered imaging test is the kidney ultrasound.^5,10,14,16 According to a recent meta-analysis, this modality may detect anomalies in 22.1% of cases, which may be clinically relevant in 3.1% of febrile UTI cases,³⁰ but has limitations in the assessment of vesicoureteral reflux or renal scarring. In our study, an ultrasound scan was performed in 17.8% of suspected episodes and 30.1% of cUTI cases, possibly in relation to the high frequency of febrile cases; while voiding cystourethrography (VCUG) and renal scintigraphy scans were ordered in very small percentages. According to the recent update of the European Association of Urology/ European Society for Paediatric Urology guidelines on UTI in children, VCUG is indicated after the first febrile UTI in infants under 12 months, regardless of ultrasound results.¹⁶ In the recent update of the Spanish clinical practice guidelines, age less than 12 months, in absence of other risk factors, is not considered an indication for VCUG.⁵

The indications for antibiotic prophylaxis have been restricted recently. In our study, it was prescribed in 28 cases, which amounted to 3.7% of the total episodes diagnosed as UTIs (2% of initially suspected episodes), a figure that was significantly lower compared to other studies,¹⁹ and in an additional 39 cases (2.8%) patients were already receiving it. Overall, the antimicrobials prescribed for prophylaxis adhered to recommendations, with only one case of prescription of nitrofurantoin, which is not indicated for prophylaxis based on the summary of product characteristics.

There are limitations to our study: we were unable to calculate frequencies, as we could not ascertain whether all suspected cases were reported, and we only analyzed certain variables in relation to the presence or absence of fever. The representation of the autonomous communities of Spain was uneven and not proportional, partly due to bureaucratic barriers, and providers collaborated on a voluntary basis. The state of alarm imposed a few months after the declaration of the COVID-19 pandemic may have driven changes in clinical practice during the study period.

The main strength of this study, with its nationwide multicenter design, is that it contributes information on the real-world management of suspected UTIs in every care setting through the prospective collection of data on all aspects of management that can help identify areas of improvement. The providers who submitted data were not given specific directions on which criteria to apply to confirm or rule out the diagnosis of UTI,  which makes this data particularly valuable for understanding how UTI is diagnosed in real-world practice.

Other studies have contributed data regarding confirmed UTI cases or have conducted surveys regarding the management of UTIs without including actual case data.¹²

CONCLUSIONS

To conclude, we would like to highlight the following:

• In a significant number of cases, the diagnosis did not adhere to current guidelines either because a urine sample was not collected for culture, even in episodes in which treatment was initiated, or because the sample collection method was inadequate (collection by means of a urine collection bag in incontinent patients).
• There was overtreatment in terms of the number of initiated courses of treatment, the duration of treatment (in both febrile and afebrile episodes), and the high use of broad-spectrum antibiotics.
• Follow-up urine cultures were performed in a high proportion of cases.
• The turnaround time for tests was not optimal.
• The findings of our study can help identify and raise awareness of areas in which clinical practice deviates current recommendations, thus contributing to its improvement. Further studies should be conducted to assess how these trends evolve over time.

CONFLICTS OF INTEREST

The authors have no conflicts of interest to declare in relation to the preparation and publication of this article.

AUTHORSHIP

All authors have contributed equally to the preparation of the published manuscript.

Preliminary results from this project were presented as oral communications at the 2024 Congress of the AEPap (Spanish Association of Primary Care Pediatrics). Preliminary results from this work have also been accepted for presentation as an oral communication and a poster at the 2026 Congress of the AEPap.

FUNDING

The study was awarded an AEPap-FPS grant for research in primary care pediatrics in 2019.

ABBREVIATIONS

AC: autonomous community · cUTI: confirmed urinary tract infection ·FUO: fever of unknown origin · PC: primary care · SPA: suprapubic aspiration · UC: urine culture · usUTI: unconfirmed suspected urinary tract infection · UTI: urinary tract infection.

ACKNOWLEDGMENTS

We take this opportunity to thank all the contributors who helped with the identification and documentation of the cases.

REFERENCES

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