Ibuprofen versus mecillinam for uncomplicated cystitis - a randomized controlled trial study protocol
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Ibuprofen versus mecillinam for uncomplicated cystitis - a randomized controlled trial study protocol. / Vik, Ingvild; Bollestad, Marianne; Grude, Nils; Bærheim, Anders; Mölstad, Sigvard; Bjerrum, Lars; Lindbæk, Morten.
In: B M C Infectious Diseases, Vol. 14, 693, 17.12.2014, p. 1-6.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Ibuprofen versus mecillinam for uncomplicated cystitis - a randomized controlled trial study protocol
AU - Vik, Ingvild
AU - Bollestad, Marianne
AU - Grude, Nils
AU - Bærheim, Anders
AU - Mölstad, Sigvard
AU - Bjerrum, Lars
AU - Lindbæk, Morten
PY - 2014/12/17
Y1 - 2014/12/17
N2 - BackgroundAlthough 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/DesignThis 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.DiscussionIf 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.Trial registrationEudraCTnr: 2012-002776-14. ClinicalTrials.gov: NCT01849926.
AB - BackgroundAlthough 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/DesignThis 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.DiscussionIf 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.Trial registrationEudraCTnr: 2012-002776-14. ClinicalTrials.gov: NCT01849926.
U2 - 10.1186/s12879-014-0693-y
DO - 10.1186/s12879-014-0693-y
M3 - Journal article
C2 - 25516016
VL - 14
SP - 1
EP - 6
JO - B M C Infectious Diseases
JF - B M C Infectious Diseases
SN - 1471-2334
M1 - 693
ER -
ID: 129144087