title: Ibuprofen versus mecillinam for uncomplicated cystitis--a randomized controlled trial study protocol.
abstract: BACKGROUND
  Although uncomplicated cystitis is often self-limiting, most such patients will be prescribed antibiotic treatment. We are investigating whether treatment of cystitis with an NSAID is as effective as an antibiotic in achieving symptomatic resolution.
  
  
  METHODS
  This is a randomized, controlled, double blind trial following the principles of Good Clinical Practice. Women between the ages of 18 to 60 presenting with symptoms of uncomplicated cystitis are screened for eligibility. 500 women from four sites in Norway, Sweden and Denmark are allocated to treatment with 600 mg ibuprofen three times a day or 200 mg mecillinam three times a day for three days. Allocation is conducted using block randomization. The primary outcome is the number of patients who feel cured by day four as recorded in a diary. Adverse events will be handled and reported in accordance with Good Clinical Practice.
  
  
  CONCLUSIONS
  If treatment of uncomplicated cystitis with ibuprofen is as effective as mecillinam for symptom relief, we can potentially reduce the use of antibiotics on a global scale.
  
  
  BACKGROUND
  EudraCTnr: 2012-002776-14. ClinicalTrials.gov: NCT01849926.
authors.affiliation: Antibiotic Centre of Primary Care, Department of General Practice, Institute of Health and Society, University of Oslo, Pb 1130, Blindern, 0318, Oslo, Norway. ingvild.vik@medisin.uio.no.|Department of General Practice, Oslo Accident and Emergency Out Patient Clinic, Storgata 40, 0182, Oslo, Norway. ingvild.vik@medisin.uio.no.
authors.forename: Ingvild
authors.initials: I
authors.lastname: Vik
authors.affiliation: Antibiotic Centre of Primary Care, Department of General Practice, Institute of Health and Society, University of Oslo, Pb 1130, Blindern, 0318, Oslo, Norway. marianne.bollestad@medisin.uio.no.|Division of Medicine, Stavanger University Hospital, Pb 8100, 4068, Stavanger, Norway. marianne.bollestad@medisin.uio.no.
authors.forename: Marianne
authors.initials: M
authors.lastname: Bollestad
authors.affiliation: Antibiotic Centre of Primary Care, Department of General Practice, Institute of Health and Society, University of Oslo, Pb 1130, Blindern, 0318, Oslo, Norway. nigrud@siv.no.|Department of Medical Microbiology, Vestfold Hospital Trust, Pb 2168, 3103, Tønsberg, Norway. nigrud@siv.no.
authors.forename: Nils
authors.initials: N
authors.lastname: Grude
authors.affiliation: Department of Global Public Health and Primary Care, University of Bergen, Pb 7804, 5018, Bergen, Norway. Anders.Barheim@igs.uib.no.
authors.forename: Anders
authors.initials: A
authors.lastname: Bærheim
authors.affiliation: Department of Clinical Sciences, Malmoe, General Practice, University of Lund, box 117, 221 00, Lund, Sweden. sigvard.molstad@med.lu.se.
authors.forename: Sigvard
authors.initials: S
authors.lastname: Mölstad
authors.affiliation: Department of Public Health, University of Copenhagen, Pb 2099, 1014, Copenhagen, Denmark. lbjerrum@sund.ku.dk.
authors.forename: Lars
authors.initials: L
authors.lastname: Bjerrum
authors.affiliation: Antibiotic Centre of Primary Care, Department of General Practice, Institute of Health and Society, University of Oslo, Pb 1130, Blindern, 0318, Oslo, Norway. morten.lindbak@medisin.uio.no.
authors.forename: Morten
authors.initials: M
authors.lastname: Lindbæk
mesh_terms: D000293:Adolescent; D000328:Adult; D000560:Amdinocillin / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D002985:Clinical Protocols; D003556:Cystitis / Q000188:drug therapy*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007052:Ibuprofen / Q000627:therapeutic use*; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D000894:Anti-Inflammatory Agents, Non-Steroidal; D000560:Amdinocillin; D007052:Ibuprofen