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

Urinary Tract Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01488955
• Other study ID #: 20110512-BG
• Status: Completed
• Phase: Phase 4
• First received: December 7, 2011
• Last updated: August 7, 2014
• Start date: February 2012
• Est. completion date: July 2014

Study information

• Verified date: August 2014
• Source: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 494
• Est. completion date: July 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Drug:
• Ibuprofen
400 mg oral once a day from day 0 for 3 days
• 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

Locations

Country	Name	City	State
Germany	Univercity Medical Center Goettingen	Goettingen
Germany	MHH Hannover	Hannover

Sponsors (2)

Lead Sponsor	Collaborator
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH	University Medical Center Goettingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	number of defined daily doses of antibiotics		day 0-28	No
Secondary	number of SAEs		day 0-28	Yes
Secondary	number of relapses		day 0-28	No
Secondary	number of patients without symptoms		day 4 and day 7	No
Secondary	symptom load (AUC)		day 0-4	No
Secondary	symptom load		day 0-7	No
Secondary	symptoms load with regard to specific symptoms		day 0-7	No
Secondary	activity impairment assessment		day 0-7	No