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Abstract
Objectives To investigate the effect of adding point-of-care (POC) susceptibility testing to POC culture on appropriate use of antibiotics as well as clinical and microbiological cure for patients with suspected uncomplicated urinary tract infection (UTI) in general practice.
Design Open, individually randomised controlled trial.
Setting General practice.
Participants Women with suspected uncomplicated UTI, including elderly patients above 65, patients with recurrent UTI and patients with diabetes. The sample size calculation predicted 600 patients were needed.
Interventions Flexicult SSI-Urinary Kit was used for POC culture and susceptibility testing and ID Flexicult was used for POC culture only.
Main outcome measures Primary outcome: appropriate antibiotic prescribing on the day after consultation defined as either (1) patient with UTI: to prescribe a first-line antibiotic to which the infecting pathogen was susceptible or a second line if a first line could not be used or (2) patient without UTI: not to prescribe an antibiotic. UTI was defined by typical symptoms and significant growth in a reference urine culture performed at one of two external laboratories.
Secondary outcomes: clinical cure on day five according to a 7-day symptom diary and microbiological cure on day 14. Logistic regression models taking into account clustering within practices were used for analysis.
Results 20 general practices recruited 191 patients for culture and susceptibility testing and 172 for culture only. 63% of the patients had UTI and 12% of these were resistant to the most commonly used antibiotic, pivmecillinam. Patients randomised to culture only received significantly more appropriate treatment (OR: 1.44 (95% CI 1.03 to 1.99), p=0.03). There was no significant difference in clinical or microbiological cure.
Conclusions Adding POC susceptibility testing to POC culture did not improve antibiotic prescribing for patients with suspected uncomplicated UTI in general practice. Susceptibility testing should be reserved for patients at high risk of resistance and complications.
Trial registration number NCT02323087; Results.
- urinary tract infections
- microbiological diagnosis
- culture media
- point-of-care testing
- antibiotics
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Footnotes
Contributors All authors have made substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work. The corresponding author drafted the manuscript and all other authors revised it critically for important intellectual content. AH conducted the study supported by all other authors. She drafted the first manuscript and all other authors revised the entire manuscript critically and approved the final version for publication. She also serves as the guarantor for the study. VS has mainly supervised statistics and NFM has mainly supervised technical issues regarding the POC tests and microbiological culture. All authors have approved the final version to be published. All authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Funding This study was funded by: (a) 2016, the University of Copenhagen (b) Læge Sofus Carl Emil Friis og Hustru Olga Doris Friis’ legat, (c) SSI Diagnostika (materials). None of the funders had any influence on study design, collection, analysis, and interpretation of data or writing of the article or the decision to submit it for publication. None of the authors is financially influenced by any of the funders.
Competing interests None declared.
Ethics approval All procedures followed were in accordance with the Helsinki Declaration of 1975, as revised in 1983. The study was approved by the Ethical Committee for the Capital Region of Denmark (ref. no: H-3-2014-107). All patients gave written informed consent prior to participating in the study.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement All authors had access to and can take responsibility for data and analysis. The authors commit to making the relevant anonymised patient level data available on reasonable request.