Ibuprofen versus mecillinam for uncomplicated cystitis in adult, non-pregnant women.
The aim of this study is to evaluate ibuprofen versus mecillinam in the treatment of uncomplicated cystitis in otherwise healthy, adult, non-pregnant women.
Our hypothesis is that symptomatic treatment with NSAIDs is not inferior to antibiotic treatment in this group. Another unanswered question is whether NSAIDs (ibuprofen) might have an antimicrobial effect.
To our knowledge no large randomized controlled trial (RCT) has previously been done to explore this. There was a pilot study in Germany in 2010 (18), and the same group has just started recruiting patients to a new RCT in Germany where they will compare treatment with ibuprofen to fosfomycin-trometamol. Also a group in Switzerland has planned to do an RCT where they will compare treatment with diclofenac to norfloxacin, but they have not started recruiting patients yet. (21) Both these studies have chosen to use quite broad spectrum antibiotics. We have chosen mecillinam which is a narrow spectrum antibiotic, it has a relatively low resistance driving effect, beneficial adverse effect profile and it is approved for use in the first trimester of pregnancy in the National guidelines for antibiotic use in primary care. (8) We have chosen to use the NSAID ibuprofen over other NSAIDs because of its relatively beneficial adverse effect profile and the dosage we will be using is lower than the maximum recommended daily intake.
The design of the study will be a double blinded RCT. Half of the patients will receive treatment with mecillinam and the other half will receive treatment with ibuprofen. The study will follow the principles of Good Clinical Practice (GCP).
Prosjektbeskrivelse med vedlegg
Intern fremleggelse - Ja
Godkjent av: Jørund Straand