CTU Bern (Clinical Trials Unit)

HWI trial

The HWI trial is a randomized, double blind trial to compare symptomatic therapy of uncomplicated lower urinary tract infections to antibiotic treatment in the ambulatory setting. CTU Bern was involved in designing, implementing, conducting, and analyzing the study.

This trial was conducted in 17 general practices in the German speaking part of Switzerland. The recruitment started in 2012. At the beginning of 2015, 253 women with lower UTI aged 18 to 70 gave their written informed consent. They were randomly assigned 1:1 to symptomatic treatment with the NSAID diclofenac (n=133) or antibiotic treatment with norfloxacin (n=120). The randomization sequence was computer generated, stratified by practice, blocked, and concealed using sealed, sequentially numbered drug containers.

The conclusion is, that diclofenac is inferior to norfloxacin for symptom relief of UTI and is likely to be associated with an increased risk of pyelonephritis, even though it reduces antibiotic use in women with uncomplicated lower UTI.

Services

Methodology and Project Management

CTU Bern was involved in the planning phase of the trial and contributed to the trial design.

Data management

CTU Bern was responsible to set up the study database as well as monthly accrual and study progress reports.

Monitoring

Monitoring was performed by a CTU Monitor visiting participating sites either during study conduct or at the end of the study.

Statistics

All main analyses were done at CTU Bern.

 

Selected publications

Symptomatic treatment of uncomplicated lower urinary tract infections in the ambulatory setting: BMJ 2017; 359 doi: https://doi.org/10.1136/bmj.j4784 (Published 08 November 2017)