Dipsticks and point-of-care Microscopy in Urinary Tract Infections in primary care: Results of the MicUTI pilot cluster randomised controlled trial
ObjectivesTo evaluate the feasibility of a novel point-of-care test (POCT) management strategy including phase contrast microscopy for bacteriuria and urinary dipsticks for erythrocytes to guide antibiotic prescribing in women with suspected uncomplicated urinary tract infection (uUTI) in general practice.DesignPilot cluster randomised controlled trial in 20 general practices in Germany. Practices were assigned 1:1 to POCT-guided management or usual care. All urine samples were sent for urine culture. Follow-up over 28 days involved symptom diaries, telephone interviews, and medical record review.OutcomesPrimary outcomes were recruitment and retention rates. Secondary outcomes included total and inappropriate antibiotic use, symptom duration and burden, recurrent and upper UTIs, re-consultations, and diagnostic accuracy of microscopy versus urine culture. Mixed-effects models accounted for clustering.ResultsOver 8 months, 157 women were recruited (90 intervention, 67 control), median of 7.5 patients per practice (range 1–15). Participant retention at day 28 was 75%. Baseline characteristics were well balanced. Antibiotic use was similar in both groups: 77% (intervention) vs. 79% (control) at initial consultation. The mean number of antibiotic courses over 28 days was 0.96 (intervention) vs. 1.00 (control), with no indication of reduced prescribing. Phase-contrast microscopy showed limited diagnostic accuracy, especially for ruling out infection (negative predictive value 46%). Exploratory analyses suggested that if GPs had access to urine culture results at the point of care, antibiotic prescribing in the intervention group could have been higher than in routine care.ConclusionThe POCT-guided management approach for suspected uUTIs is feasible but presents implementation and methodological challenges. Recruitment varied across sites and was lower in the control group practices, highlighting the risk of differential recruitment. Retention was below the expected 80%, indicating the need for efficient follow-up strategies in future trials. Explorative analyses suggest that simply adding diagnostic information may not support antibiotic stewardship. Novel POCTs should be carefully assessed for their influence on prescribing before routine use. Trial registration: ClinicalTrials.gov NCT05667207.
10125
- 10.1016/s0140-6736(21)02724-0
- Jan 1, 2022
- Lancet (London, England)
287
- 10.1136/bmj.e686
- Feb 21, 2012
- BMJ
2
- 10.1136/bmjopen-2023-079345
- Mar 1, 2024
- BMJ Open
67
- 10.1159/000486138
- Jan 17, 2018
- Urologia Internationalis
51
- 10.3389/fmed.2022.1033486
- Nov 8, 2022
- Frontiers in medicine
5463
- 10.7326/0003-4819-158-3-201302050-00583
- Feb 5, 2013
- Annals of Internal Medicine
97
- 10.1159/000493368
- Sep 19, 2018
- Urologia Internationalis
218
- 10.2196/15588
- Apr 3, 2020
- JMIR Perioperative Medicine
45
- 10.1016/j.cmi.2019.01.011
- Jan 25, 2019
- Clinical Microbiology and Infection
1
- 10.1016/j.aprim.2019.02.001
- Jan 1, 2019
- Atencion Primaria
- Research Article
33
- 10.3399/bjgp18x695285
- Feb 26, 2018
- British Journal of General Practice
The effectiveness of using point-of-care (POC) urine culture in primary care on appropriate antibiotic use is unknown. To assess whether use of the Flexicult™ SSI-Urinary Kit, which quantifies bacterial growth and determines antibiotic susceptibility at the point of care, achieves antibiotic use that is more often concordant with laboratory culture results, when compared with standard care. Individually randomised trial of females with uncomplicated urinary tract infection (UTI) in primary care research networks (PCRNs) in England, the Netherlands, Spain, and Wales. Multilevel regression compared outcomes between the two groups while controlling for clustering. In total, 329 participants were randomised to POC testing (POCT) and 325 to standard care, and 324 and 319 analysed. Fewer females randomised to the POCT arm than those who received standard care were prescribed antibiotics at the initial consultation (267/324 [82.4%] versus 282/319 [88.4%], odds ratio [OR] 0.56, 95% confidence interval [CI] = 0.35 to 0.88). Clinicians indicated the POCT result changed their management for 190/301 (63.1%). Despite this, there was no statistically significant difference between study arms in antibiotic use that was concordant with laboratory culture results (primary outcome) at day 3 (39.3% POCT versus 44.1% standard care, OR 0.84, 95% CI = 0.58 to 1.20), and there was no evidence of any differences in recovery, patient enablement, UTI recurrences, re-consultation, antibiotic resistance, and hospitalisations at follow-up. POCT culture was not cost-effective. Point-of-care urine culture was not effective when used mainly to adjust immediate antibiotic prescriptions. Further research should evaluate use of the test to guide initiation of 'delayed antibiotics'.
- Research Article
37
- 10.3399/bjgpo.2021.0212
- Dec 17, 2021
- BJGP Open
BackgroundBetween-country differences have been described in antibiotic prescribing for respiratory tract infection (RTI) in primary care, but not yet for diagnostic testing procedures and prescribing confidence.AimTo describe between-country differences in RTI management, particularly diagnostic testing and antibiotic prescribing, and investigate which factors relate to antibiotic prescribing and GPs’ prescribing confidence.Design & settingProspective audit in 18 European countries.MethodAn audit of GP-registered patient, clinical, and management characteristics for patients presenting with sore throat and/or lower RTI (n = 4982), and GPs' confidence in their antibiotic prescribing decision. Factors related to antibiotic prescribing and confidence were analysed using multi-level logistic regression.ResultsAntibiotic prescribing proportions varied considerably: <20% in four countries, and >40% in six countries. There was also considerable variation in point-of-care (POC) testing (0% in Croatia, Moldova, and Romania, and >65% in Denmark and Norway, mainly for C-reactive protein [CRP] and group A streptococcal [strep A] infection), and in laboratory or hospital-based testing (<3% in Hungary, the Netherlands, and Spain, and >30% in Croatia, Georgia, Greece, and Moldova, mainly chest X-ray and white blood cell counting). Antibiotic prescribing was related to illness severity, comorbidity, age, fever, and country, but not to having performed a POC test. In nearly 90% of consultations, GPs were confident in their antibiotic prescribing decision.ConclusionDespite high confidence in decisions about antibiotic prescribing, there is considerable variation in the primary care of RTI in European countries, with GPs prescribing antibiotics overall more often than is considered appropriate. POC testing may enhance the quality of antibiotic prescribing decisions if it can safely reverse decisions confidently made on clinical grounds alone to prescribe antibiotics.
- Research Article
17
- 10.1016/j.pcd.2017.08.003
- Sep 14, 2017
- Primary Care Diabetes
Antimicrobial resistance in women with urinary tract infection in primary care: No relation with type 2 diabetes mellitus
- Research Article
29
- 10.1186/s12875-014-0187-4
- Nov 25, 2014
- BMC Family Practice
BackgroundUrinary tract infections (UTI) are the most frequent bacterial infection affecting women and account for about 15% of antibiotics prescribed in primary care. However, some women with a UTI are not prescribed antibiotics or are prescribed the wrong antibiotics, while many women who do not have a microbiologically confirmed UTI are prescribed antibiotics. Inappropriate antibiotic prescribing unnecessarily increases the risk of side effects and the development of antibiotic resistance, and wastes resources.POETIC is a randomised controlled trial of a Point Of Care Test (POCT) (Flexicult™) guided UTI management strategy for use in primary care, which may help General Practitioners more effectively decide both whether or not to prescribe antibiotics, and if so, to select the most appropriate antibiotic.Methods/design614 adult female patients will be recruited from four primary care research networks (Wales, England, Spain, the Netherlands) and individually randomised to either POCT guided care or the guideline-informed ‘standard care’ arm. Urine and stool samples (where possible) will be obtained at presentation (day 1) and two weeks later for microbiological analysis. All participants will be followed up on the course of their illness and their quality of life, using a 2 week self-completed symptom diary. At 3 months, a primary care notes review will be conducted for evidence of further evidence of treatment failures, recurrence, complications, hospitalisations and health service costs.The primary objective is to compare appropriate antibiotic use on day 3 between the POCT and standard care arms using multi-level logistic regression to produce an odds ratio and associated 95% confidence interval. Costs of the two management approaches will be assessed in terms of the primary outcome.DiscussionAlthough the Flexicult™ POCT is used in some countries in routine primary care, it’s clinical and cost effectiveness has never been evaluated in a randomised clinical trial. If shown to be effective, the use of this POCT could benefit individual sufferers and provide evidence for health care authorities to develop evidence based policies to combat the spread and impact of the unprecedented rise of infections caused by antibiotic resistant bacteria in Europe.Trial registration numberISRCTN65200697 (Registered 10 September 2013).
- Research Article
7
- 10.1093/jac/dkab392
- Nov 8, 2021
- Journal of Antimicrobial Chemotherapy
Hospital-based surveillance of antimicrobial resistance may be irrelevant as a guide to antimicrobial use for urinary tract infections (UTIs) in primary care. To highlight the value of online computerized decision support systems (CDSS) in providing information on the surveillance of antimicrobial resistance in community-acquired UTIs. We collected the susceptibility profile for key antibiotics by type of UTI involving Escherichia coli from 2017 to 2020, using queries for UTI (Q-UTI) submitted to a French CDSS. We compared these results with those from the MedQual French surveillance system for community-acquired UTI and the European Antimicrobial Resistance Surveillance Network (EARS-NET) for invasive infections. We collected 43 591 Q-UTI, of which 10 192 (23%) involved E. coli: 40% cystitis, 32% male-UTI, and 27% pyelonephritis. Resistance was 41.3% (95% CI, 40.3%-42.2%) for amoxicillin, 16.6% (95% CI, 15.9%-17.3%) for fluoroquinolones, 6.6% (95% CI, 6.1%-7.0%) for third-generation cephalosporins (3GC), and 5.7% (95% CI, 5.2%-6.1%) for aminoglycosides. Resistance to amoxicillin was lower than that reported in MedQual (42.7%, P value = 0.004), and in EARS-NET (55.2%, P value < 0.001). For fluoroquinolones, resistance was higher than in MedQual (12.0%, P value < 0.001) and EARS-NET (15.8%, P value = 0.041). In complicated pyelonephritis and male UTI, fluoroquinolone resistance peaked at ∼20%. For 3GC, all UTI had higher resistance than in MedQual (3.5%, P value < 0.001), but lower than in EARS-NET (9.5%, P value < 0.001). Aminoglycoside resistance was not reported by MedQual, and was lower than in EARS-NET (7.1%, P value < 0.001). CDSS can inform prescribers in real-time about the ecology and surveillance of E. coli resistance in community-acquired UTI. In complicated upper UTIs, they can underline the risk of empirical use of fluoroquinolones and suggest preferential use of 3GC.
- Research Article
1
- 10.1093/jac/dkae349
- Oct 8, 2024
- Journal of Antimicrobial Chemotherapy
ObjectivesTo review the evidence on healthcare professionals’ (HCPs) and patients’ views of the use of point-of-care tests (POCTs) in the management of acute respiratory tract infections (RTIs) in primary care settings.MethodsWe conducted a systematic review of studies up to 28 April 2023. We included studies that included qualitative methods and results; focused on HCPs’ and/or patients’ views/experiences of POCTs for acute RTIs; and were conducted in primary care settings. We conducted a thematic synthesis to identify how their views on POCTs and interventions can support test use (PROSPERO registration: CRD42019150347).ResultsWe included 33 studies, developing 9 categories each for HCP and patient data. We identified 38 factors affecting POCT use: 28 from HCPs and 10 from patients. Factors exist outside and within consultations, and post-consultations, illustrating that some cannot be addressed by HCPs alone. Fourteen interventions were identified that could address factors and support POCT use, with 7 interventions appearing to address the most factors. Some interventions were beyond the scope of HCPs and patients and needed to be addressed at system and organizational levels. Both groups had mixed views on the use of POCTs and highlighted implementation challenges.DiscussionThis review highlights numerous factors affecting POCT use in primary care. Policy-makers planning to implement POCTs are likely to achieve more by providing multi-faceted interventions that target factors outside, within, and post-consultation. Some interventions may need to be already established before POCT introduction. Whilst evidence beyond general practice is limited, similar factors suggest that similar context-tailored interventions would be appropriate.
- Research Article
20
- 10.1186/s12875-015-0322-x
- Aug 21, 2015
- BMC Family Practice
BackgroundUrinary tract infection (UTI) is a common infection in primary care and is the second leading reason for prescription of antibiotics in Denmark. The diagnosis is often based on symptoms and urine dip-stick, which has limited validity, causing the risk of unnecessary antibiotic prescription. Additionally, with increasing antibiotic resistance, the risk of choosing an antibiotic to which an infecting pathogen is resistant is rising. Combined point-of-care-tests (POCT) for urine culture and susceptibility testing have been developed and validated for primary care, and performing such a test in all patients with suspected UTI in primary care seems rational in order to reduce the use of inappropriate antibiotics. However, the clinical effect of the culture and susceptibility test has not yet been investigated. This study aims to investigate whether POCT urine culture and susceptibility testing decreases the inappropriate use of antibiotics and leads to faster patient recovery.Methods/designRandomized controlled open label trial of two diagnostic approaches. 750 patients with symptoms of uncomplicated UTI, consecutively contacting their general practitioner (GP), randomized to either POCT urine culture and susceptibility testing and targeted treatment or POCT urine culture without susceptibility testing and empirical treatment. Treatment is started when the POCT is read. The two groups are compared with regard to appropriate choice of antibiotics, clinical remission, and microbiological cure rates.DiscussionThe results of this study may provide important evidence to recommend POCT culture and susceptibility testing in all patients with suspected uncomplicated UTI. This could become an additional strategy to fight antibiotic resistance.Trial registrationClinicalTrials.gov NCT02323087.
- Research Article
3
- 10.1093/jac/dkae127
- May 6, 2024
- The Journal of antimicrobial chemotherapy
FebriDx® is a CE-marked, single-use point-of-care test with markers for bacterial [C-reactive protein (CRP)] and viral [myxovirus resistance protein A (MxA)] infection, using finger-prick blood samples. Results are available after 10-12 min. We explored the usability and potential impact of FebriDx® in reducing antibiotic prescriptions for lower respiratory tract infection (LRTI) in primary care, and the feasibility of conducting a randomized controlled trial (RCT). Patients (aged ≥1 year) with LRTI deemed likely to receive antibiotic prescription were recruited at nine general practices and underwent FebriDx® testing. Data collection included FebriDx® results, antibiotic prescribing plan (before and after testing) and re-consultation rates. Staff completed System Usability Scale questionnaires. From 31 January 2023 to 9 June 2023, 162 participants participated (median age 57 years), with a median symptom duration of 7 days (IQR 5-14). A valid FebriDx® result was obtained in 97% (157/162). Of 155 patients with available results, 103 (66%) had no detectable CRP or MxA, 28 (18%) had CRP only, 5 (3%) had MxA only, and 19 (12%) had both CRP and MxA. The clinicians' stated management plan was to prescribe antibiotics for 86% (134/155) before testing and 45% (69/155) after testing, meaning a 41% (95% CI: 31%, 51%) difference after testing, without evidence of increased re-consultation rates. Ease-of-use questionnaires showed 'good' user-friendliness. Use of FebriDx® to guide antibiotic prescribing for LRTI in primary care was associated with a substantial reduction in prescribing intentions. These results support a fully powered RCT to confirm its impact and safety.
- Research Article
23
- 10.1016/j.cmi.2021.05.032
- Jun 7, 2021
- Clinical Microbiology and Infection
Herbal treatment with uva ursi extract versus fosfomycin in women with uncomplicated urinary tract infection in primary care: a randomized controlled trial
- Front Matter
12
- 10.1136/bmj.39357.571343.80
- Oct 18, 2007
- BMJ
Antibiotics for respiratory tract infections in primary care
- Research Article
- 10.1186/s12887-025-05688-4
- May 26, 2025
- BMC Pediatrics
BackgroundInappropriate antibiotic prescription in paediatric uncomplicated acute respiratory tract infections (ARTIs) in primary care (PC) settings contributes to antimicrobial resistance. We aimed (1) to identify and describe educational interventions and their components to optimise antibiotic prescription for paediatric uncomplicated ARTIs in PC, and (2) to map contextual factors that may influence antibiotic prescription and the implementation of interventions.MethodsWe searched three electronic databases (Medline, CINAHL and Epistemonikos) to identify reviews on the effectiveness of educational interventions and contextual factors, for optimising antibiotic prescription (Concept) in paediatric uncomplicated ARTIs (Population) in PC (Context). We included reviews that reported explicitly the search strategy used. Two previously calibrated reviewers independently screened the literature, extracted data, and assessed the methodological limitations. We applied the “best-fit framework synthesis approach”, based on the main constructs of the Consolidated Framework for Implementation Research, and coded the data deductively by groups of analysis for reviews reporting effectiveness (e.g. antibiotic or consultation rate) or by thematic synthesis for reviews reporting contextual factors (e.g. healthcare professionals’ knowledge) based on a logic model.ResultsWe identified 11 reviews evaluating education intervention and their characteristics, including 182 interventions with at least one educational component (educational intervention plus another type, educational or non-educational), with 136 providing information on characteristics and effectiveness. Successful interventions’ characteristics were related to the kind of intervention (e.g. communication skill training), mode of delivery (e.g. face to face), and target population (e.g. parents/caregivers). From the 22 reviews on contextual factors, healthcare professionals’ attitudes and perceptions, knowledge, and health system and professionals’ teams’ organization (inner setting), were the most frequent themes; less information was available on individuals´ characteristics (parents/children) and on outer setting (e.g. policies).ConclusionWe identified a large number of heterogeneous educational interventions. Combining educational interventions plus another type targeting both parents/caregivers and healthcare professionals, and considering their needs and their context may improve antibiotic prescribing in children. Further research is needed on consultation rate, knowledge, attitudes, and satisfaction outcomes and contextual factors, as well as on the cost-effectiveness of the interventions.RegistrationThe protocol was published in OSF iRegistries in May 2021 (Elizondo-Alzola, U).
- Research Article
3
- 10.3399/bjgpo.2024.0024
- Apr 30, 2024
- BJGP open
FebriDx is a single-use, analyser-free, point-of-care test with markers for bacterial (C-reactive protein [CRP]) and viral (myxovirus resistance protein A [MxA]) infection, measured on a finger-prick blood sample. As part of a larger feasibility study, we explored the views of healthcare professionals (HCPs) and patients on the use of FebriDx to safely reduce antibiotic prescriptions for lower respiratory tract infections (LRTIs) in primary care. Remote semi-structured qualitative interviews were conducted in South England. In total, 22 individuals (12 patients who underwent FebriDx testing and 10 HCPs from general practices that conducted testing) participated in interviews, which were analysed thematically. Patients and HCPs expressed positive views about use of the test. They felt FebriDx was a useful tool to inform prescribing decisions and provided a visual aid to support shared decision making and appropriate antibiotic use. Most felt it would be feasible to integrate use into routine primary care consultations. Some practical difficulties with blood collection and interpreting results, which impacted on usability, were identified. Some patients' reactions to negative test results suggested the need for better communication alongside use of the test. FebriDx was perceived as a useful tool to guide antibiotic prescribing and support shared decision making. Initial practical problems with testing and communicating results are potential barriers to use. Training and practice on using the test and effective communication are likely to be important elements in ensuring patient understanding and satisfaction, and successful adoption.
- Research Article
51
- 10.1186/1478-4505-12-61
- Oct 10, 2014
- Health Research Policy and Systems
BackgroundInappropriate use and overuse of antibiotics is a serious concern in the treatment of upper respiratory tract infections (URTIs), especially in developing countries. In recent decades, information disclosure and public reporting (PR) has become an instrument for encouraging good practice in healthcare. This study evaluated the impact of PR on antibiotic prescribing for URTIs in a sample of primary care institutions in China.MethodsA matched-pair cluster-randomized trial was undertaken in QJ city, with 20 primary care institutions participating in the trial. Participating institutions were matched into pairs before being randomly assigned into a control and an intervention group. Prescription statistics were disclosed to patients, health authorities, and health workers monthly within the intervention group, starting from October 2013. Outpatient prescriptions for URTIs were collected from both groups before (1st March to 31st May, 2013) and after the intervention (1st March to 31st May, 2014). A total of 34,815 URTI prescriptions were included in a difference-in-difference analysis using multivariate linear or logistic regression models, controlling for patient attributes as well as institutional characteristics.ResultsOverall, 90% URTI prescriptions required antibiotics and 21% required combined use of antibiotics. More than 77% of URTI prescriptions required intravenous (IV) injection or infusion of drugs. PR resulted in a 9 percentage point (95% CI -17 to -1) reduction in the use of oral antibiotics (adjusted RR =39%, P =0.027), while the use of injectable antibiotics remained unchanged. PR led to a 7 percentage point reduction (95% CI -14 to 0; adjusted RR =36%) in combined use of antibiotics (P =0.049), which was largely driven by a significant reduction in male patients (-7.5%, 95% CI -14 to -1, P =0.03). The intervention had little impact on the use of IV injections or infusions, or the total prescription expenditure.ConclusionsThe results suggest that PR could improve prescribing practices in terms of reducing oral antibiotics and combined use of antibiotics; however, the impacts were limited. We suggest that PR would probably be enhanced by provider payment reform, management and training for providers, and health education for patients.
- Research Article
19
- 10.3399/bjgp15x684361
- Mar 30, 2015
- British Journal of General Practice
The prevalence of targeted and serendipitous treatment for, and associated recovery from, urinary tract infection (UTI) in pre-school children is unknown. To determine the frequency and suspicion of UTI in children who are acutely ill, along with details of antibiotic prescribing, its appropriateness, and whether that appropriateness impacted on symptom improvement and recovery. Prospective observational cohort study in primary care sites in urban and rural areas in England and Wales. Systematic urine sampling from children aged <5 years presenting in primary care with acute illness with culture in NHS laboratories. Of 6079 children's urine samples, 339 (5.6%) met laboratory criteria for UTI and 162 (47.9%) were prescribed antibiotics at the initial consultation. In total, 576/7101 (8.1%) children were suspected of having a UTI prior to urine sampling, including 107 of the 338 with a UTI (clinician sensitivity 31.7%). Children with a laboratory-diagnosed UTI were more likely to be prescribed antibiotics when UTI was clinically suspected than when it was not (86.0% versus 30.3%, P<0.001). Of 231 children with unsuspected UTI, 70 (30.3%) received serendipitous antibiotics (that is, antibiotics prescribed for a different reason). Overall, 176 (52.1%) children with confirmed UTI did not receive any initial antibiotic. Organism sensitivity to the prescribed antibiotic was higher when UTI was suspected than when treated serendipitously (77.1% versus 26.0%; P<0.001). Children with UTI prescribed appropriate antibiotics at the initial consultation improved a little sooner than those with a UTI who were not prescribed appropriate antibiotics initially (3.5 days versus 4.0 days; P = 0.005). Over half of children with UTI on culture were not prescribed antibiotics at first presentation. Serendipitous UTI treatment was relatively common, but often inappropriate to the organism's sensitivity. Methods for improved targeting of antibiotic treatment in children who are acutely unwell are urgently needed.
- Research Article
1
- 10.3390/antibiotics12020377
- Feb 12, 2023
- Antibiotics
Lower respiratory tract infections (LRTIs) in primary care are a promising target for antibiotic stewardship. A clinical trial in Switzerland showed a large decrease in antibiotic prescriptions with procalcitonin guidance (cut-off < 0.25 µg/L) compared with usual care. However, one-third of patients with low procalcitonin at baseline received antibiotics by day 28. To explore the factors associated with the overruling of initial procalcitonin guidance. Secondary analysis of a cluster randomized trial in which patients with an LRTI were included. Using the characteristics of patients, their disease, and general practitioners (GPs), we conducted a multivariate logistic regression, adjusted for clustering. Ninety-five out of 301 (32%) patients with low procalcitonin received antibiotics by day 28. Factors associated with an overruling of procalcitonin guidance were: a history of chest pain (adjusted OR [aOR] 1.81, 95% confidence interval 1.03-3.17); a prescription of chest X-ray by the GP (aOR 4.65, 2.32-9.34); a C-reactive protein measured retrospectively above 100 mg/L (aOR 7.48, 2.34-23.93, reference ≤ 20 mg/L); the location of the GP practice in an urban setting (aOR 2.27, 1.18-4.37); and the GP's number of years of experience (aOR per year 1.05, 1.01-1.09). Overruling of procalcitonin guidance was associated with GPs' socio-demographic characteristics, pointing to the general behavioral problem of overprescription by physicians. Continuous medical education and communication training might support the successful implementation of procalcitonin point-of-care tests aimed at antibiotic stewardship.
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