Observational study to evaluate the microbiological efficacy of an antibiotic therapy with Nitroxolin (3 x 250 mg p.o.) in patients with lower urinary tract infectio
- Conditions
- N39.0Urinary tract infection, site not specified
- Registration Number
- DRKS00004678
- Lead Sponsor
- niversitätsklinikum JenaZentrum für Infektionsmedizin und Krankenhaushygiene
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 30
(1) men and women aged at least 60 years and a therapy indication for Nitroxolin® according to the decision of the physician
(2) urine culture detecting at least one uropathogen with a bacterial count =10^5 cfu/ml
(3) at least one of the following symptoms of an urinary tract infection: dysuria, pollakisuria, intensified/new acquired urinary incontinence, odor/cloudy urine, intensified/new acquired physical weakness and abnormal fatigue, suprapubic pain
(4) written informed consent of the patient or its legal representative
(1) sepsis defined as = 2 SIRS-criteria (body temperature less than 36°C or greater than 38°C, heart rate greater than 90 beats per minute, tachypnea (high respiratory rate), with greater than 20 breaths per minute, white blood cell count less than 4000 cells/µl or greater than 12 000 cells/µl)
(2) additional systemic antibiotic therapy (besides Nitroxolin®) within the last 48 h before day 1
(3) known renal insufficiency > stadium 3 (GFR <30ml/(min*m2))
(4) liver cirrhosis Child-Pugh Score B or C
(5) known allergy against Nitroxolin®
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method proportion of patients with microbiological success defined as a reduction of bacterial count of less than 10^4 cfu/ml in the urine culture after antibiotic therapy with Nitroxolin® (3 x 250 mg p.o.) in patients with lower urinary tract infection, on day 12 ± 1 (5 ± 1 days after completion of therapy)
- Secondary Outcome Measures
Name Time Method –Microbiological and clinical efficacy during therapy (day 3) and at the end of therapy (Tag 7 ± 1) and on day 12 ± 1<br>–safety and tolerance (monitoring of side effects) on the basis of creatinine (blood) and documentation of abnormally coloured urine (yes/no)<br>–effect of urine ph-value and of Ca and Mg in the urine on clinical and microbiological efficacy<br>