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

This study has been completed.
Sponsor:
Collaborator:
University Medical Center Goettingen
Information provided by (Responsible Party):
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
ClinicalTrials.gov Identifier:
NCT01488955
First received: December 7, 2011
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Urinary Tract Infection
Drug: Ibuprofen
Drug: Fosfomycin-Trometamol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Immediate vs. Conditional Use of Antibiotics in Uncomplicated Urinary Tract Infection (UTI) - a Comparative Effectiveness Study in General Practice (ICUTI)

Resource links provided by NLM:


Further study details as provided by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH:

Primary Outcome Measures:
  • number of additional treatments with antibiotics combined with number of symptoms [ Time Frame: day 0-28 ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • number of defined daily doses of antibiotics [ Time Frame: day 0-28 ] [ Designated as safety issue: No ]
  • number of SAEs [ Time Frame: day 0-28 ] [ Designated as safety issue: Yes ]
  • number of relapses [ Time Frame: day 0-28 ] [ Designated as safety issue: No ]
  • number of patients without symptoms [ Time Frame: day 4 and day 7 ] [ Designated as safety issue: No ]
  • symptom load (AUC) [ Time Frame: day 0-4 ] [ Designated as safety issue: No ]
  • symptom load [ Time Frame: day 0-7 ] [ Designated as safety issue: No ]
  • symptoms load with regard to specific symptoms [ Time Frame: day 0-7 ] [ Designated as safety issue: No ]
  • activity impairment assessment [ Time Frame: day 0-7 ] [ Designated as safety issue: No ]

Enrollment: 494
Study Start Date: February 2012
Study Completion Date: July 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ibuprofen
Ibuprofen 400 mg oral once daily from day 0 for 3 days, placebo granulate oral day 0
Drug: Ibuprofen
400 mg oral once a day from day 0 for 3 days
Experimental: Fosfomycin-Trometamol
Fosfomycin-Trometamol (Monuril) 3 g granulate oral at day 0, placebo to Ibuprofen once a day from day 0 for 3 days
Drug: Fosfomycin-Trometamol
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 Name: Monuril

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01488955

Locations
Germany
Univercity Medical Center Goettingen
Goettingen, Germany, 37073
MHH Hannover
Hannover, Germany, 30625
Sponsors and Collaborators
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
University Medical Center Goettingen
Investigators
Principal Investigator: Eva Hummers-Pradier, Prof. Abt. Allgemeinmedizin, Universitätsmedizin Göttingen, Humboldtallee 38, 37073 Göttingen
  More Information

No publications provided by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
ClinicalTrials.gov Identifier: NCT01488955     History of Changes
Other Study ID Numbers: 20110512-BG
Study First Received: December 7, 2011
Last Updated: August 7, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH:
bacterial infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Ibuprofen
Fosfomycin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on October 01, 2014