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Completed

NCT Number: NCT01488955

Immediate vs. Conditional Use of Antibiotics in Uncomplicated Urinary Tract Infection (UTI) - ICUTI

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.

Secondary aim of the study is the safety evaluation of both treatment strategies with respect to SAEs during treatment. Additionally, relapse frequency after 28 days is evaluated.

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Key information

Conditions

Urinary Tract Infection Bacterial Infections Bacterial Infections and Mycoses Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Univercity Medical Center Goettingen, Göttingen, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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
  • limited 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

Treatment and study plan

Ibuprofen

Drug

400 mg oral once a day from day 0 for 3 days

Fosfomycin-Trometamol

Drug

8 g granulate with 3 g Fosfomycin-Trometamol oral once at day 0, placebo to Ibuprofen once a day oral from day 0 for 3 days

Other names: Monuril

Primary outcomes

  1. number of additional treatments with antibiotics combined with number of symptoms

    Time frame: day 0-28

    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.

Secondary outcomes

  1. number of defined daily doses of antibiotics

    Time frame: day 0-28

  2. number of SAEs

    Time frame: day 0-28

  3. number of relapses

    Time frame: day 0-28

  4. number of patients without symptoms

    Time frame: day 4 and day 7

  5. symptom load (AUC)

    Time frame: day 0-4

  6. symptom load

    Time frame: day 0-7

  7. symptoms load with regard to specific symptoms

    Time frame: day 0-7

  8. activity impairment assessment

    Time frame: day 0-7

Sponsors and collaborators

Lead sponsor

Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

Other

Collaborators

  • University Medical Center Goettingen

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 8, 2011
Registry last updated
Aug 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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