Symptomatic Therapy of Uncomplicated Lower Urinary Tract Infections in the Ambulatory Setting.
Summary
We propose to perform a randomized controlled patient and assessor blind trial in women between the ages of 18 to 70 years with acute uncomplicated UTI to evaluate initial symptomatic treatment for 3 days with the non-steroidal anti-inflammatory drug diclofenac (experimental intervention) against immediate antibiotic treatment with norfloxacin for 3 days (control intervention). Both interventions are followed by optional delayed antibiotic treatment with single dose fosfomycin if deemed necessary by the patients. The primary objective is to determine whether initial symptomatic treatment followed by optional delayed antibiotic treatment (experimental intervention) is non-inferior to immediate antibiotic treatment (control intervention) in terms of symptom resolution.
Timeline
- Start
- 2012-02
- Primary completion
- 2014-12
- Completion
- 2015-01
Outcome
Missed primary endpoint
Stopped: “New power calculation (reduction of necessary patient number)”
paper Conclusion Diclofenac is inferior to norfloxacin for symptom relief of UTI PMID 29113968 ↗
Publications
- Sachdeva A, Rai BP, Veeratterapillay R, Harding C, Nambiar A. Non-steroidal anti-inflammatory drugs for treating symptomatic uncomplicated urinary tract infections in non-pregnant adult women. Cochrane Database Syst Rev. 2024 Dec 19;12(12):CD014762. doi: 10.1002/14651858.CD014762.pub2.
- Kronenberg A, Butikofer L, Odutayo A, Muhlemann K, da Costa BR, Battaglia M, Meli DN, Frey P, Limacher A, Reichenbach S, Juni P. Symptomatic treatment of uncomplicated lower urinary tract infections in the ambulatory setting: randomised, double blind trial. BMJ. 2017 Nov 7;359:j4784. doi: 10.1136/bmj.j4784.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Diclofenac | Other / unclassified | 75 mg | — |
| Comparator | Norfloxacin | Small molecule | 400 mg | — |
| Background | Fosfomycin | Small molecule | 3 g | — |