Ignite Creation Date:
2024-05-05 @ 10:07 PM
Last Modification Date:
2024-10-26 @ 10:14 AM
Study NCT ID:
NCT01039545
Status:
TERMINATED
Last Update Posted:
2015-07-09
First Post:
2009-12-24
Brief Title:
Symptomatic Therapy of Uncomplicated Lower Urinary Tract Infections in the Ambulatory Setting
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
Symptomatic Therapy of Uncomplicated Lower Urinary Tract Infections in the Ambulatory Setting A Randomized Double Blind Trial
Status:
TERMINATED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
New power calculation reduction of necessary patient number
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We propose to perform a randomized controlled patient and assessor blind trial in women between the ages of 18 to 70 years with acute uncomplicated UTI to evaluate initial symptomatic treatment for 3 days with the non-steroidal anti-inflammatory drug diclofenac experimental intervention against immediate antibiotic treatment with norfloxacin for 3 days control intervention Both interventions are followed by optional delayed antibiotic treatment with single dose fosfomycin if deemed necessary by the patients 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 control intervention in terms of symptom resolution
Detailed Description:
Background
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
Objective
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
Methods
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
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
Objective
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
Methods
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None