Trial document




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  DRKS00003611

Trial Description

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Title

Immediate vs. Conditional Use of Antibiotics in Uncomplicated Urinary Tract Infection (UTI) - a Comparative Effectiveness Study in General Practice (ICUTI)

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Trial Acronym

ICUTI

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URL of the Trial

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Brief Summary in Lay Language

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.
Patients of the treatment group will get Ibuprofen first and antibiotics only when the disease is worsening.
Patients of the control group will be treated with Fosfomycin-Trometamol from the start, wich is the state-of-the-art treatment of this disease.
This is a double-blinded study, which means that neither patients nor doctors know which treatment a patient will receive.

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Brief Summary in Scientific Language


It is well known that higher numbers of antibiotic treatments leads to an increase of adverse reactions in combination with the development of bacterial resistences. Therefore, antibiotic therapies of uncomplicated infects should be avoided. Aim of the current clinical trial is to create evidence-based data on antibiotic treatments in the field of uncomplicated urinary infection. It investigates if the number of antibiotic treatments can be reduced by a symptomatic therapy first - antibiotic therapy only if medical complaints are ongoing - without worsening symptoms and enhancing the number of adverse events. Therefore, patients of the treatment group are getting Ibuprofen (antibiotic therapy only if urinary infection is worsening). Patients of the control group are getting antibiotic therapy with Fosfomycin-Trometamol, which is the state-of-the-art therapy.

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Organizational Data

  •   DRKS00003611
  •   2012/03/14
  •   2011/12/07
  •   yes
  •   Approved
  •   5986M, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

  •   2011-002271-42 
  •   NCT01488955  (clinicaltrials.gov)
  •   4037504 
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Health Condition or Problem studied

  •   Classification Code 10046544 (Urinary infection)
  •   N39 -  Other disorders of urinary system
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Interventions/Observational Groups

  •   Monuril (Fosfomycin-Trometamol); single treatment with 3000 mg Granulat oral
  •   IbuHEXAL 400 mg tablets (Ibuprofen), 3 tablets of 400 mg for 3 days
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo
  •   Treatment
  •   Parallel
  •   IV
  •   No
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Primary Outcome

The number of additional treatments with antibiotics combined with the number of symptoms during day 0 to day 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.

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Secondary Outcome

The number of defined daily doses of antibiotics until day 28. The number of SAEs during day 28. The number of relapses during day 28. Number of patients without symptoms between day 4 and day 7. Symptom load (AUC) until day 4. symptom load until day 7. Symptom load with regard to specific symptoms until day 7. Activity impairment assessment until day 7.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2012/02/29
  •   494
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   65   Years
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Additional 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

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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
- imited 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

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Addresses

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    • Universitätsmedizin Göttingen
    • Robert-Koch-Straße 40
    • 37075  Göttingen
    • Germany
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    • Medizinische Hochschule Hannover, Institut für Allgemeinmedizin
    • Ms.  Dr.  Jutta  Bleidorn 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover, Institut für Allgemeinmedizin
    • Ms.  Dr.  Jutta  Bleidorn 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/03/24
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Trial Publications, Results and other Documents

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