Immediate vs. Conditional Use of Antibiotics in Uncomplicated Urinary Tract Infection (UTI) - ICUTI
1 other identifier
interventional
494
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2012
Typical duration for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2011
CompletedFirst Posted
Study publicly available on registry
December 8, 2011
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedAugust 8, 2014
August 1, 2014
2 years
December 7, 2011
August 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
day 0-28
Secondary Outcomes (8)
number of defined daily doses of antibiotics
day 0-28
number of SAEs
day 0-28
number of relapses
day 0-28
number of patients without symptoms
day 4 and day 7
symptom load (AUC)
day 0-4
- +3 more secondary outcomes
Study Arms (2)
Ibuprofen
EXPERIMENTALIbuprofen 400 mg oral once daily from day 0 for 3 days, placebo granulate oral day 0
Fosfomycin-Trometamol
EXPERIMENTALFosfomycin-Trometamol (Monuril) 3 g granulate oral at day 0, placebo to Ibuprofen once a day from day 0 for 3 days
Interventions
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
Eligibility Criteria
You may qualify if:
- Women (18 - 65 years)
- Symptoms of uncomplicated urinary tract infection: dysuria, frequency/urgency of micturition, and/or low abdominal pain
- written informed consent
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Univercity Medical Center Goettingen
Göttingen, 37073, Germany
MHH Hannover
Hanover, 30625, Germany
Related Publications (3)
Sachdeva A, Rai BP, Veeratterapillay R, Harding C, Nambiar A. Non-steroidal anti-inflammatory drugs for treating symptomatic uncomplicated urinary tract infections in non-pregnant adult women. Cochrane Database Syst Rev. 2024 Dec 19;12(12):CD014762. doi: 10.1002/14651858.CD014762.pub2.
PMID: 39698942DERIVEDGagyor 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.
PMID: 26698878DERIVEDGagyor 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.
PMID: 22742538DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eva Hummers-Pradier, Prof.
Abt. Allgemeinmedizin, Universitätsmedizin Göttingen, Humboldtallee 38, 37073 Göttingen
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2011
First Posted
December 8, 2011
Study Start
February 1, 2012
Primary Completion
February 1, 2014
Study Completion
July 1, 2014
Last Updated
August 8, 2014
Record last verified: 2014-08