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

Primary Purpose

Urinary Tract Infection

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Ibuprofen
Fosfomycin-Trometamol
Sponsored by
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Tract Infection focused on measuring bacterial infection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Univercity Medical Center Goettingen
  • MHH Hannover

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ibuprofen

Fosfomycin-Trometamol

Arm Description

Ibuprofen 400 mg oral once daily from day 0 for 3 days, placebo granulate oral day 0

Fosfomycin-Trometamol (Monuril) 3 g granulate oral at day 0, placebo to Ibuprofen once a day from day 0 for 3 days

Outcomes

Primary Outcome Measures

number of additional treatments with antibiotics combined with number of symptoms
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
number of SAEs
number of relapses
number of patients without symptoms
symptom load (AUC)
symptom load
symptoms load with regard to specific symptoms
activity impairment assessment

Full Information

First Posted
December 7, 2011
Last Updated
August 7, 2014
Sponsor
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Collaborators
University Medical Center Goettingen
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1. Study Identification

Unique Protocol Identification Number
NCT01488955
Brief Title
Immediate vs. Conditional Use of Antibiotics in Uncomplicated Urinary Tract Infection (UTI) - ICUTI
Official Title
Immediate vs. Conditional Use of Antibiotics in Uncomplicated Urinary Tract Infection (UTI) - a Comparative Effectiveness Study in General Practice (ICUTI)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Collaborators
University Medical Center Goettingen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection
Keywords
bacterial infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
494 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ibuprofen
Arm Type
Experimental
Arm Description
Ibuprofen 400 mg oral once daily from day 0 for 3 days, placebo granulate oral day 0
Arm Title
Fosfomycin-Trometamol
Arm Type
Experimental
Arm Description
Fosfomycin-Trometamol (Monuril) 3 g granulate oral at day 0, placebo to Ibuprofen once a day from day 0 for 3 days
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
400 mg oral once a day from day 0 for 3 days
Intervention Type
Drug
Intervention Name(s)
Fosfomycin-Trometamol
Other Intervention Name(s)
Monuril
Intervention Description
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
Primary Outcome Measure Information:
Title
number of additional treatments with antibiotics combined with number of symptoms
Description
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.
Time Frame
day 0-28
Secondary Outcome Measure Information:
Title
number of defined daily doses of antibiotics
Time Frame
day 0-28
Title
number of SAEs
Time Frame
day 0-28
Title
number of relapses
Time Frame
day 0-28
Title
number of patients without symptoms
Time Frame
day 4 and day 7
Title
symptom load (AUC)
Time Frame
day 0-4
Title
symptom load
Time Frame
day 0-7
Title
symptoms load with regard to specific symptoms
Time Frame
day 0-7
Title
activity impairment assessment
Time Frame
day 0-7

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Hummers-Pradier, Prof.
Organizational Affiliation
Abt. Allgemeinmedizin, Universitätsmedizin Göttingen, Humboldtallee 38, 37073 Göttingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univercity Medical Center Goettingen
City
Goettingen
ZIP/Postal Code
37073
Country
Germany
Facility Name
MHH Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
26698878
Citation
Gagyor I, Bleidorn J, Kochen MM, Schmiemann G, Wegscheider K, Hummers-Pradier E. Ibuprofen versus fosfomycin for uncomplicated urinary tract infection in women: randomised controlled trial. BMJ. 2015 Dec 23;351:h6544. doi: 10.1136/bmj.h6544.
Results Reference
derived
PubMed Identifier
22742538
Citation
Gagyor I, Hummers-Pradier E, Kochen MM, Schmiemann G, Wegscheider K, Bleidorn J. Immediate versus conditional treatment of uncomplicated urinary tract infection - a randomized-controlled comparative effectiveness study in general practices. BMC Infect Dis. 2012 Jun 28;12:146. doi: 10.1186/1471-2334-12-146.
Results Reference
derived

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

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