Trial document




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  DRKS00004678

Trial Description

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Title

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

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Trial Acronym

NITRO_UTI

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Urinary tract infections are the most common infections caused by bacteria. To eliminate the causative pathogens, these infections can be treated successfully with antibiotics. In this context, a steady increase in antibiotic resistant bacteria is observed. In the laboratory, studies have shown that Nitroxolin® acts against many different types of bacteria that can cause urinary tract infections and others. Since the inhibitory effect on bacterial growth is achieved through various mechanisms, it is unlikely that Nitroxolin® resistance can develop. Since 1962, Nitroxolin® is approved for the treatment of chronic urinary tract infections, and for prevention of new urinary tract infections. However, data on the efficacy in patients were not previously published. Therefore, in the present study the microbiological efficacy of Nitroxolin® is observed in patients with lower urinary tract infections. The study is planned with 90 patients with a minimum age of 60 years and a therapy indication for Nitroxolin® according to the decision of the doctor. No additional measures will be carried out compared to the routine treatment. At the observational study a chunk of data from the routinely conducted urine cultures, urine analysis and blood tests will be evaluated according to defined criteria.

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Brief Summary in Scientific Language

During the last 15 years, a steady increase is observed in multi-drug resistant gram-negative pathogens linked to urinary tract infections. In this context ESBL (extended-spectrum beta-lactamase) producing bacteria are increasing worldwide. As a result of the increasing development of antibiotic resistance, antibiotics Cotrimoxazol and Ciprofloxacin are no longer first choice for empirical therapy of ambulant-acquired uncomplicated urinary tract infection according to the currently published national S3 guideline. As drug of first choice, Nitrofurantoin, Fosfomycin and Pivmecillinam, which is not available in Germany, are now specified. The wide use of Fosfomycin, which is more often used due to the development of resistance in intensive care units, must be evaluated critically as monotherapy. Under monotherapy mutations can cause quickly resistance, leading to the loss of effectiveness of this important antibiotic in critically ill patients.
Despite the approval of Nitroxolin® for acute and chronic urinary tract infections without limitation, no entry of a clinical study can be found in PubMed. The published data regarding Nitroxolin® support a very good efficacy in vitro. Furthermore, the substance is excreted in high concentrations in the urine. Data on the efficacy in patients were not published yet. The primary endpoint of this observational study is the 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).

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Organizational Data

  •   DRKS00004678
  •   2013/04/10
  •   [---]*
  •   yes
  •   Approved
  •   3694-02/13, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   N39.0 -  Urinary tract infection, site not specified
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Interventions/Observational Groups

  •   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.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

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)

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Secondary Outcome

– 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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2013/06/13
  •   90
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   60   Years
  •   no maximum age
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Additional 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

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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®

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Addresses

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    • Universitätsklinikum Jena Zentrum für Infektionsmedizin und Krankenhaushygiene
    • Mr.  Prof. Dr. med.  Mathias  Pletz 
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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    • Universitätsklinikum Jena, Klinik für Geriatrie
    • Ms.  Dr. med.  Anja  Kwetkat 
    • Bachstraße 18
    • 07740  Jena
    • Germany
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    • Universitätsklinikum Jena Zentrum für Infektionsmedizin und Krankenhaushygiene
    • Mr.  Prof. Dr. med.  Mathias  Pletz 
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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    • Universitätsklinikum Jena Klinik für Geriatrie
    • Ms.  Dr. med.  Anja  Kwetkat 
    • Bachstraße 18
    • 07740  Jena
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Hannoversche Straße 28-30
    • 10115  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/10/27
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.