Symptomatic Therapy of Uncomplicated Lower Urinary Tract Infections in the Ambulatory Setting.
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|ClinicalTrials.gov Identifier: NCT01039545|
Recruitment Status : Terminated (New power calculation (reduction of necessary patient number))
First Posted : December 25, 2009
Last Update Posted : July 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Urinary Tract Infections||Drug: Diclofenac Drug: Norfloxacin||Phase 4|
Urinary tract infection (UTI) is the most frequent bacterial infection diagnosed and treated by general practitioners and accounts for about 15% of antibiotic prescriptions in ambulatory medicine. World-wide raise of antibiotic resistance among uropathogens, most commonly Escherichia coli, threatens treatment of UTI. Uncomplicated UTI, the most frequent manifestation of UTI, is a benign, self-limited disease and the primary goal of treatment is symptom relief not cure. Antibiotic treatment reduces the duration of symptoms by 1-2 days from 5-6 days to 3-4 days. Symptoms of cystitis are the result of an inflammation evoked by bacterial products which stimulate the production of prostaglandins by a cyclooxygenase dependent mechanism. Therefore, we propose that symptom control with a non-steroidal anti-inflammatory drug (NSAID), an inhibitor of cyclooxygenase 1 and 2, may be equally effective for symptom control as standard antibiotic therapy in non-complicated UTI and may therefore help to reduce antibiotic consumption.
The primary objective is to determine whether initial symptomatic treatment followed by optional delayed antibiotic treatment (experimental intervention) is non-inferior to immediate antibiotic treatment followed by optional delayed antibiotic treatment (control intervention) in terms of symptom resolution.
The secondary objective is to determine whether the experimental intervention is superior to control in reducing the proportion of patients undergoing antibiotic treatment.
Randomized controlled patient and assessor blind trial performed in general practices. Study population are women between the ages of 18 to 70 years with acute uncomplicated UTI. The experimental intervention will consist of symptomatic treatment with diclofenac 75mg twice daily, followed by optional, delayed antibiotic treatment with single dose of 3g fosfomycin if deemed necessary by the patient. The control intervention will consist of immediate antibiotic treatment with norfloxacin 400mg twice daily for three days, followed by optional, delayed antibiotic treatment with single dose of 3g fosfomycin if deemed necessary by the patient. Patients will use a diary to describe symptoms for 10 days. A follow-up telephone interview will be performed on day 10 and 30.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||253 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Symptomatic Therapy of Uncomplicated Lower Urinary Tract Infections in the Ambulatory Setting. A Randomized, Double Blind Trial|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||January 2015|
Active Comparator: antibiotic
Norfloxacin for three days, followed by fosfomycin on day 4 if deemed necessary
Norfloxacin 400mg twice daily for 3 days, followed by fosfomycin 3g single dose on day 4 if deemed necessary
Diclofenac retard for three days, followed by fosfomycin on day 4 if deemed necessary
Diclofenac retard 75mg twice daily for 3 days, followed by fosfomycin 3g single dose on day 4 if deemed necessary
- The proportion of patients with resolution of symptoms on day 4 [ Time Frame: one month ]
- The proportion of patients ever on antibiotics between randomization at day 1 and follow-up at day 30 [ Time Frame: one month ]
- The proportion of patients using single dose fosfomycin on day 4 [ Time Frame: one month ]
- The proportion of patients with re-consultations because of UTI within 30 days [ Time Frame: one month ]
- The mean composite symptom scores on days 4, 7 and 30 [ Time Frame: one month ]
- The proportion of patients with resolution of symptoms on day 7 [ Time Frame: one month ]
- The proportion of patients with complete resolution of symptoms on days 4 and 7 [ Time Frame: one month ]
- The time until resolution of symptoms [ Time Frame: one month ]
- The proportion of patients with adverse events [ Time Frame: one month ]
- Mean overall patient stratification [ Time Frame: one month ]
- Health-related quality of life on day 4 [ Time Frame: one month ]
- Number of working days lost [ Time Frame: one month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01039545
|Institute for Infectious Diseases, University of Berne|
|Berne, Switzerland, 3010|
|Principal Investigator:||Andreas Kronenberg||University of Bern|