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BEHANDLING-God og treffsikker diagnostikk, behandling og rehabilitering

NSAIDs versus mecillinam for uncomplicated cystitis in adult, non-pregnant women - a randomized controlled trial

Alternative title: null

Awarded: NOK 8.7 mill.

Uncomplicated cystitis is the most common bacterial infection in women and the condition comprises 3-4% of all consultations in general practice. 50% of all women will undergo an uncomplicated bladder catheter during life, of which 20% will experience recurrent infections.Most women who go to a doctor when they have symptoms of an uncomplicated cystitis will receive antibiotic treatment. This contributes to an increase in antibiotic resistance, both in the population and in the individual patient. An increased incidence of resistant strains is a problem both for patients because we will lack treatment options for common infections and for the environment as the global release of antibiotics into the environment is constantly increasing and disrupting the natural bacterial flora. A pilot study has shown that ibuprofen (Ibux) was as good as the antibiotic ciprofloxacin in reducing symptoms in women with acute uncomplicated cystitis. In our research project, we wanted to investigate whether this finding can be confirmed in a larger study. The project is a collaboration between research institutions in Norway, Sweden and Denmark. We conducted a randomized controlled double-blind study comparing ibuprofen and mecillinam in the treatment of uncomplicated cystitis in adult, fertile women aged 18-60 years.To include patients in this study, a questionnaire was used. The use of this questionnaire was investigated in a study at the Oslo Accident and Emergency Out Patient Clinic, which was included in the first part of the project.If we found that ibuprofen is as effective as mecillinam in treating this condition, this would be an important contribution to reducing the use of antibiotics globally. This is beneficial for the environment and will reduce the cost of health care internationally. Recruitment is completed and we managed to recruit a total of 383 patients in line with the power calculation. Overall the study has gone well with few logistical problems. A total of 6 articles have been published from the whole project, one is submitted for publication, a total of 7 articles.The first was an article on the protocol. The second article reported findings from a randomized controlled trial of a diagnostic algorithm for symptoms of uncomplicated cystitis at the Oslo Accident and Emergency Out Patient Clinic. This study used the same questionnaire as in the IMUTI study. Included were 441 patients with acute cystitis who were randomized to regular medical consultation or a nurse-managed diagnostic algorithm.The conclusion was that the use of a diagnostic algorithm is a safe and effective method of treating women with symptoms of uncomplicated cystitis on an emergency room. This simplification of treatment strategy can lead to a more rational use of consultation time and more stringent adherence to national antibiotic guidelines for a common disorder. The third article was a predictor article on the algorithm of the out-of-hours service that dealt with predictors of duration of symptoms in this population.The 4th article was a comparison of bacteriological findings in 3 different Norwegian cohorts over a 10 year period. This was published in the BJGP Open. It reports on which pathogens cause cystitis in women and which resistance patterns have been reported during the different periods.The 5th article dealt with the effect of mecillinam in cystitis caused by E. coli with ESBL resistance. The 6th article was the main article on the effect of ibuprofen vs mecillinam in uncomplicated cystitis. The main article confirmed that more than half of ibuprofen patients did not need antibiotics. But at the same time, significantly more women had complications in the form of pyelonephritis in the ibuprofen group. The 7th article is an article that has analyzed predictors of which patients who received ibuprofen who needed additional treatment with antibiotics. This has been submitted for publication.

2 additional papers have been published partly based on the material from the project. Jansåker F, Bollestad M, Vik I, Lindbæk M, Bjerrum L, Frimodt-Møller N, Knudsen JD.Pivmecillinam for Uncomplicated Lower Urinary Tract Infections Caused by Staphylococcus saprophyticus-Cumulative Observational Data from Four Recent Clinical Studies. Antibiotics (Basel). 2019 May 7;8(2). Syre H, Hetland MAK, Bernhoff E, Bollestad M, Grude N, Simonsen GS, Löhr IH.Microbial risk factors for treatment failure of pivmecillinam in community-acquired urinary tract infections ca used by ESBL-producing Escherichia coli.APMIS. 2019 Nov 22.

Uncomplicated cystitis (urinary tract infection) is the most common bacterial infection in women and the condition comprises 3-4% of all consultations in general practice. 50% of all women will go through an uncomplicated cystitis during life, among these 20% will experience recurring infections. Most women who see a doctor when they have symptoms of an uncomplicated cystitis will get antibiotic treatment. This contributes to an increase in bacterial resistance, both in a population and individually. An increased rate of resistant strains is a problem both for the patients as we run out of treatment options and for the environment as the global outlet of antibiotics into the nature is ever increasing and interfering with the natural bacterial floras. A pilot study has shown that the NSAID ibuprofen was equally good as the antibiotic ciprofloxacin in reducing symptoms in women with acute uncomplicated cystitis. In our research project we want to investigate whether this finding can be confirmed in a lar ger study. The project is a cooperation between research facilities in Norway, Sweden and Denmark. We will do a randomized controlled double blind trial where we compare ibuprofen and mecillinam in the treatment of uncomplicated cystitis in adult, non-pre gnant women. To include patients in this study a questionnaire will be used. The use of this questionnaire is evaluated in a study at the Emergency Medical Agency in Oslo. The preliminary results indicate that the use of this questionnaire is equally go od in diagnosing an uncomplicated cystitis as a doctors consult. The use of this questionnaire will be further evaluated in this study. If we find that ibuprofen is equally effective as mecillinam in treating this condition, this will be an important con tribution to reducing the use of antibiotics on a global scale. This is beneficial to the environment and will reduce costs in health services internationally

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BEHANDLING-God og treffsikker diagnostikk, behandling og rehabilitering