Clinical trial NCT01488955: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Tract Infection
Keywords: bacterial infection
Lead sponsor: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Sponsor class: OTHER
Collaborators: name: University Medical Center Goettingen
First posted: 2011-12-08
Enrollment: 494
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: number of additional treatments with antibiotics combined with number of symptoms
timeFrame: day 0-28
Secondary outcomes:
measure: number of defined daily doses of antibiotics
timeFrame: day 0-28
measure: number of SAEs
timeFrame: day 0-28
measure: number of relapses
timeFrame: day 0-28
measure: number of patients without symptoms
timeFrame: day 4 and day 7
measure: symptom load (AUC)
timeFrame: day 0-4
measure: symptom load
timeFrame: day 0-7
measure: symptoms load with regard to specific symptoms
timeFrame: day 0-7
measure: activity impairment assessment
timeFrame: day 0-7
Other outcomes:
Locations:
city: Goettingen
country: Germany
facility: Univercity Medical Center Goettingen
city: Hannover
country: Germany
facility: MHH Hannover
Study officials:
affiliation: Abt. Allgemeinmedizin, Universitätsmedizin Göttingen, Humboldtallee 38, 37073 Göttingen
name: Eva Hummers-Pradier, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.