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Symptomatic Therapy of Uncomplicated Lower Urinary Tract Infections in the Ambulatory Setting.

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University Hospital Inselspital, Berne
Sponsor:
Collaborators:
University of Bern
Clinic for Infectious Diseases, University Hospital Bern, Switzerland
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01039545
First received: December 24, 2009
Last updated: September 3, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Urinary Tract Infections
Drug: Diclofenac
Drug: Norfloxacin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Symptomatic Therapy of Uncomplicated Lower Urinary Tract Infections in the Ambulatory Setting. A Randomized, Double Blind Trial

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • The proportion of patients with resolution of symptoms on day 4 [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportion of patients ever on antibiotics between randomization and day 30 of follow-up [ Time Frame: one year ] [ Designated as safety issue: No ]
  • The proportion of patients using single dose fosfomycin on day 4 [ Time Frame: one year ] [ Designated as safety issue: No ]
  • The proportion of patients with re-consultations because of UTI within 30 days [ Time Frame: one year ] [ Designated as safety issue: No ]
  • The mean composite symptom scores on days 4, 7 and 30 [ Time Frame: one year ] [ Designated as safety issue: No ]
  • The proportion of patients with resolution of symptoms on day 7 [ Time Frame: one year ] [ Designated as safety issue: No ]
  • The proportion of patients with complete resolution of symptoms on days 4 and 7 [ Time Frame: one year ] [ Designated as safety issue: No ]
  • The time until resolution of symptoms [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • The proportion of patients with adverse events [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Mean overall patient stratification [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Health-related quality of life on day 4 [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Number of working days lost [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: February 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: antibiotic
Norfloxacin for three days, followed by fosfomycin on day 4 if deemed necessary
Drug: Norfloxacin
Norfloxacin 400mg twice daily for 3 days, followed by fosfomycin 3g single dose on day 4 if deemed necessary
Experimental: symptomatic
Diclofenac retard for three days, followed by fosfomycin on day 4 if deemed necessary
Drug: Diclofenac
Diclofenac retard 75mg twice daily for 3 days, followed by fosfomycin 3g single dose on day 4 if deemed necessary

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • female
  • age between 18 and 70 years
  • at least one typical symptom of acute, lower urinary tract infection out of dysuria, frequency, macrohaematuria, cloudy or smelly urine or self-diagnosed cystitis
  • a urine dipstick test should be indicative of UTI by positive nitrite or leucocyturia

Exclusion Criteria

  • duration of UTI symptoms for more than 7 days before physician's visit
  • clinical signs of invasiveness such as fever (axillary body temperature >38 degrees Celsius), costovertebral pain or tenderness, rigors, nausea or vomiting
  • known or suspicion of anatomical or functional abnormality of the urinary tract
  • vaginal symptoms: discharge, irritation
  • diabetes mellitus
  • immunosuppression (e.g. prednisone equivalent >10mg per day for >14 days, chemotherapy, radiotherapy, immunomodulators, HIV infection, neutropenia)
  • - any other serious comorbidity as judged by the treating physician
  • bladder catheter in situ or during the past 30 days
  • pregnancy
  • recurrent urinary tract infection (more than 3 infections during the last 12 months)
  • antibiotic treatment during the last 4 weeks
  • hypersensitivity to one of the study medications
  • psychiatric illness or dementia
  • unable to communicate in German or French language
  • documented coagulopathy (including therapy with coumarine derivatives) or documented history of gastric or duodenal ulcer disease
  • documented renal insufficiency grade III or higher (calculated GFR <60) or known congestive heart failure (NYHA III or higher)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01039545

Contacts
Contact: Andreas Kronenberg +41 (0)31 632 86 57 andreas.kronenberg@ifik.unibe.ch

Locations
Switzerland
Institute for Infectious Diseases, University of Berne Recruiting
Berne, Switzerland, 3010
Principal Investigator: Andreas Kronenberg         
Sponsors and Collaborators
University Hospital Inselspital, Berne
University of Bern
Clinic for Infectious Diseases, University Hospital Bern, Switzerland
Investigators
Principal Investigator: Andreas Kronenberg University of Bern
  More Information

No publications provided

Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT01039545     History of Changes
Other Study ID Numbers: 254/09
Study First Received: December 24, 2009
Last Updated: September 3, 2014
Health Authority: Switzerland: Ethikkommission
Switzerland: Swissmedic

Keywords provided by University Hospital Inselspital, Berne:
Urinary tract infections
Anti-bacterial agents

Additional relevant MeSH terms:
Communicable Diseases
Infection
Urinary Tract Infections
Urologic Diseases
Diclofenac
Norfloxacin
Analgesics
Analgesics, Non-Narcotic
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antineoplastic Agents
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014