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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00004678

Enrollment

Registered

2013-04-10

Start date

2013-06-13

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

N39.0

Interventions

Group 1: In patients with urinary tract infections that were medicated with Nitroxolin 3 x 250 mg p.o. a chunk of routine data will be collected.

Eligibility

Sex/Gender

All

Age

60 Years to No maximum

Inclusion criteria

Inclusion criteria: (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

Exclusion criteria

Exclusion criteria: (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®

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
– Microbiological and clinical efficacy during therapy (day 3) and at the end of therapy (Tag 7 ± 1) and on day 12 ± 1 – safety and tolerance (monitoring of side effects) on the basis of creatinine (blood) and documentation of abnormally coloured urine (yes/no) – effect of urine ph-value and of Ca and Mg in the urine on clinical and microbiological efficacy	—

Countries

Germany

Contacts

Public ContactAnja Kwetkat

Universitätsklinikum Jena Klinik für Geriatrie

anja.kwetkat@med.uni-jena.de+49 (0) 3641-9-34901

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026