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 infection - NITRO_UTI

niversitätsklinikum JenaZentrum für Infektionsmedizin und Krankenhaushygiene0 sites30 target enrollmentApril 10, 2013

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: N39.0
Sponsor: niversitätsklinikum JenaZentrum für Infektionsmedizin und Krankenhaushygiene
Enrollment: 30
Status: Completed
Last Updated: last year

No summary available.

Registry

who.int

Start Date

April 10, 2013

End Date

October 27, 2014

Last Updated

last year

Study Type

Observational

Sex

All

Sponsor

niversitätsklinikum JenaZentrum für Infektionsmedizin und Krankenhaushygiene

•(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®