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

NCT01039545 | Terminated Phase 4

• 1 other identifier: 254/09
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infections

Keywords

Urinary tract infections; Anti-bacterial agents

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with resolution of symptoms on day 4

  one month

Secondary Outcomes (11)

• The proportion of patients ever on antibiotics between randomization at day 1 and follow-up at day 30

  one month

• The proportion of patients using single dose fosfomycin on day 4

  one month

• The proportion of patients with re-consultations because of UTI within 30 days

  one month

• The mean composite symptom scores on days 4, 7 and 30

  one month

• The proportion of patients with resolution of symptoms on day 7

  one month

Study Arms (2)

antibiotic

ACTIVE COMPARATOR

Norfloxacin for three days, followed by fosfomycin on day 4 if deemed necessary

Drug: Norfloxacin

symptomatic

EXPERIMENTAL

Diclofenac retard for three days, followed by fosfomycin on day 4 if deemed necessary

Drug: Diclofenac

Interventions

Diclofenac DRUG

Diclofenac retard 75mg twice daily for 3 days, followed by fosfomycin 3g single dose on day 4 if deemed necessary

symptomatic

Norfloxacin DRUG

Norfloxacin 400mg twice daily for 3 days, followed by fosfomycin 3g single dose on day 4 if deemed necessary

antibiotic

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Age between 18 and 70 years
• Written informed consent
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of Bern: collaborator
• Clinic for Infectious Diseases, University Hospital Bern, Switzerland: collaborator

Study Sites (1)

Institute for Infectious Diseases, University of Berne

Bern, 3010, Switzerland

Location

Related Publications (2)

• Sachdeva A, Rai BP, Veeratterapillay R, Harding C, Nambiar A. Non-steroidal anti-inflammatory drugs for treating symptomatic uncomplicated urinary tract infections in non-pregnant adult women. Cochrane Database Syst Rev. 2024 Dec 19;12(12):CD014762. doi: 10.1002/14651858.CD014762.pub2.

  PMID: 39698942 DERIVED

• Kronenberg A, Butikofer L, Odutayo A, Muhlemann K, da Costa BR, Battaglia M, Meli DN, Frey P, Limacher A, Reichenbach S, Juni P. Symptomatic treatment of uncomplicated lower urinary tract infections in the ambulatory setting: randomised, double blind trial. BMJ. 2017 Nov 7;359:j4784. doi: 10.1136/bmj.j4784.

  PMID: 29113968 DERIVED

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Diclofenac; Norfloxacin

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Andreas Kronenberg

  University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2009
• First Posted: December 25, 2009
• Study Start: February 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: July 9, 2015

Record last verified: 2015-07

Locations

CH (1)