Urinary Tract Infection
Conditions
Keywords
bacterial infection
Brief summary
In this study, patients with uncomplicated urinary infection are investigated. It is investigated if treatment of only symptoms of the uncomplicated urinary infection is as effective as treatment with antibiotics with respect to the outcome of the urinary infection. If this is the case, the use of antibiotics in the treatment of uncomplicated urinary infections might be reduced. Secondary aim of the study is the safety evaluation of both treatment strategies with respect to SAEs during treatment. Additionally, relapse frequency after 28 days is evaluated.
Interventions
DRUGIbuprofen
400 mg oral once a day from day 0 for 3 days
8 g granulate with 3 g Fosfomycin-Trometamol oral once at day 0, placebo to Ibuprofen once a day oral from day 0 for 3 days
Sponsors
University Medical Center Goettingen
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Women (18 - 65 years) * Symptoms of uncomplicated urinary tract infection: dysuria, frequency/urgency of micturition, and/or low abdominal pain * written informed consent
Exclusion criteria
* fever (\> 38,0) * pain on renal bed percussion * signs of complicated urinary tract infection * urinary tract infection within the last two weeks * antibiotic intake within the last 7 days * repeated intake of pain medication (i.e. ibuprofen, diclofenac) within the last 24 hours, or continuous pain medication * known pregnancy/lactation period * current immunosuppressive therapy * known renal insufficiency * known renal abnormalities * current urine catheterization * serious neurological diseases * limited condition due to other disorders * contraindications towards trial medication * current/anamnestic gastrointestinal haemorrhagia * known allergy towards trial medication * current intake of drugs potentially interacting with trial medication (i.e. oral corticosteroids, anticoagulates) * poor communication/cooperation skills * disability to understand trial information, poor German language skills * current participation in another clinical trial or clinical trial participation within the last 4 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of additional treatments with antibiotics combined with number of symptoms | day 0-28 | The study outcome is considered as positive, if the interventional group where only symptoms were treated has less additional treatments with antibiotics as the interventional group, where antibiotics are given from day 0 on. Additionally, the interventional group where only symptoms were treated has to be non inferior with respect to number of symptoms. |
Secondary
| Measure | Time frame |
|---|---|
| number of SAEs | day 0-28 |
| number of relapses | day 0-28 |
| number of patients without symptoms | day 4 and day 7 |
| number of defined daily doses of antibiotics | day 0-28 |
| symptom load | day 0-7 |
| symptoms load with regard to specific symptoms | day 0-7 |
| activity impairment assessment | day 0-7 |
| symptom load (AUC) | day 0-4 |
Countries
Germany
Outcome results
None listed