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

This study is currently recruiting participants.
Verified April 2013 by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Sponsor:
Collaborator:
University Medical Center Goettingen
Information provided by (Responsible Party):
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
ClinicalTrials.gov Identifier:
NCT01488955
First received: December 7, 2011
Last updated: April 24, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Urinary Tract Infection
 Drug: Ibuprofen
Drug: Fosfomycin-Trometamol
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Immediate vs. Conditional Use of Antibiotics in Uncomplicated Urinary Tract Infection (UTI) - a Comparative Effectiveness Study in General Practice (ICUTI)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH:

Primary Outcome Measures:
  • number of additional treatments with antibiotics combined with number of symptoms [ Time Frame: day 0-28 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • number of defined daily doses of antibiotics [ Time Frame: day 0-28 ] [ Designated as safety issue: No ]
  • number of SAEs [ Time Frame: day 0-28 ] [ Designated as safety issue: Yes ]
  • number of relapses [ Time Frame: day 0-28 ] [ Designated as safety issue: No ]
  • number of patients without symptoms [ Time Frame: day 4 and day 7 ] [ Designated as safety issue: No ]
  • symptom load (AUC) [ Time Frame: day 0-4 ] [ Designated as safety issue: No ]
  • symptom load [ Time Frame: day 0-7 ] [ Designated as safety issue: No ]
  • symptoms load with regard to specific symptoms [ Time Frame: day 0-7 ] [ Designated as safety issue: No ]
  • activity impairment assessment [ Time Frame: day 0-7 ] [ Designated as safety issue: No ]

Estimated Enrollment: 494
Study Start Date: February 2012
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ibuprofen
Ibuprofen 400 mg oral once daily from day 0 for 3 days, placebo granulate oral day 0
 Drug: Ibuprofen
400 mg oral once a day from day 0 for 3 days
Experimental: Fosfomycin-Trometamol
Fosfomycin-Trometamol (Monuril) 3 g granulate oral at day 0, placebo to Ibuprofen once a day from day 0 for 3 days
 Drug: 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
Other Name: Monuril

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01488955

Contacts
Contact: Jutta Bleidorn, MD +49 511 532 ext 2744 Bleidorn.Jutta@mh-hannover.de
Contact: Ildiko Gagyor, MD +49 551 3914221 igagyor@gwdg.de

Locations
Germany
Medical Practice Hermann Recruiting
Adelebsen, Germany, 37139
Contact: Cornelia Hermann, MD     +49-5506-95750     Dr.C.Hermann@googlemail.com    
Principal Investigator: Cornelia Hermann, MD            
Sub-Investigator: Marten Hiller            
Medical Practice Seker Recruiting
Bad Gandersheim, Germany, 37581
Contact: Güsün Seker     +49-5382-2684        
Principal Investigator: Güsün Seker            
Medical Practice Zimny Not yet recruiting
Bad Pyrmont, Germany, 31812
Contact: Hans-Hermann Zimny, Dr. med.     +49-5281-606248     dr.zimny@t-online.de    
Principal Investigator: Hans-Hermann Zimny, Dr. med.            
Medical Practice Coutelle Recruiting
Bremen, Germany, 28197
Contact: Alexander Coutelle, MD     +49-421-540852     praxis@familienmedizin-bremen.de    
Principal Investigator: Alexander Coutelle, MD            
Medical Practice Zedler Recruiting
Bremen, Germany, 28777
Contact: Siegmar Zedler, MD     +49-421-68667     dr.zedler@t-online.de    
Principal Investigator: Siegmar Zedler, MD            
Medical Practice Schelp Recruiting
Bremen, Germany, 28259
Contact: Holger Schelp     +49-421-5797675     Holger-Schelp@gmx.de    
Principal Investigator: Holger Schelp            
Sub-Investigator: Martin Gerken, MD            
Medical Practice Dickow Not yet recruiting
Burgwedel, Germany, 30938
Contact: Mona Dickow, Dr. med.     +49-5139-891929        
Principal Investigator: Mona Dickow, Dr. med.            
Medical Practice Brucker I Recruiting
Destedt, Germany, 38162
Contact: Klaus Peter Brucker, MD     +49-5306-1303     dr.brucker@t-online.de    
Principal Investigator: Klaus Peter Brucker, MD            
Medical Practice Rötterink Not yet recruiting
Garbsen, Germany, 30823
Contact: Hans-Hendrik Rötterink, Dr. med.     +49-5137-77788     hendrik.roetterink@web.de    
Principal Investigator: Hans-Hendrik Rötterink, Dr. med.            
Medical Practice Müller Not yet recruiting
Gillersheim, Germany, 37191
Contact: Manfred Müller, Dr. med.     +49-5556-1088     Praxis.Manfred.Mueller@t-online.de    
Principal Investigator: Manfred Müller, Dr. med.            
Dept. of General Medicine, Univercity Medical Center Goettingen Not yet recruiting
Goettingen, Germany, 37073
Contact: Ildiko Gagyor, MD     +49-551-3914226        
Principal Investigator: Ildiko Gagyor, MD            
Medical Practice Keske Recruiting
Göttingen, Germany, 37081
Contact: Wolfgang Keske, MD     +49-551-91191     wkeske@dgn.de    
Principal Investigator: Wolfgang Keske, MD            
Medical Practice Lückerath Recruiting
Göttingen, Germany, 37077
Contact: Marianne Lückerath, MD     +49-551-24510     mlueckerath@gmx.de    
Principal Investigator: Marianne Lückerath, MD            
Sub-Investigator: Maria Saborowski, MD            
Medical Practice Koch Recruiting
Göttingen, Germany, 37081
Contact: Thomas Koch, MD     +49-551-61700     koch.leuckel@t-online.de    
Principal Investigator: Thomas Koch, MD            
Medical Practice Borchers Recruiting
Hannover, Germany, 30539
Contact: Christoph Borchers, MD     +49-511-520237     info@hausarztpraxis-bemerode.de    
Principal Investigator: Christoph Borchers, MD            
Dept. of General Medicine, MHH Hannover Not yet recruiting
Hannover, Germany, 30625
Contact: Jutta Bleidorn, MD            
Principal Investigator: Jutta Bleidorn, MD            
Medical Practice Kuhlmann Recruiting
Hannover, Germany, 30159
Contact: Birger Kuhlmann, MD     +49-511-2206440        
Principal Investigator: Birger Kuhlmann, MD            
Sub-Investigator: Hans Heiken, MD            
Sub-Investigator: Stefanie Holm, MD            
Medical Practice Baumgarten Recruiting
Hannover, Germany, 30419
Contact: Hans-Bernd Baumgarten, MD     +49-551-792665     hbbaumgarten@hausarzt.de    
Principal Investigator: Hans-Bernd Baumgarten, MD            
Medical Practice Kiwit-Putzer Recruiting
Hannover, Germany, 30938
Contact: Dorothee Kiwit-Putzer, MD     +49-5139-8112        
Principal Investigator: Dorothee Kiwit-Putzer, MD            
Medical Practice Glatzel Recruiting
Hannover, Germany, 30163
Contact: Dirk Glatzel, MD     +49-511-638282     Glatzel@arcor.de    
Principal Investigator: Dirk Glatzel, MD            
Medical Practice Dockhorn Recruiting
Hannover, Germany, 30179
Contact: Uwe Dockhorn, MD     +49-511-6045979        
Principal Investigator: Uwe Dockhorn, MD            
Medical Practice Gosewisch Recruiting
Hannover, Germany, 30659
Contact: Andrea Gosewisch, MD     +49-511-6461916     praxis@dr-gosewisch-bothfeld.de    
Principal Investigator: Andrea Gosewisch, MD            
Medical Practice Buck Recruiting
Hannover, Germany, 30161
Contact: Andreas Buck, MD     +49-511-312828     DrAndreasBuck@aol.com    
Principal Investigator: Andreas Buck, MD            
Medical Practice Klinger-Bültemann Recruiting
Hannover, Germany, 30655
Contact: Sabine Klinger-Bültemann, MD     +49-511-5477788     klinger-bueltemann@htp-tel.de    
Principal Investigator: Sabine Klinger-Bültemann, MD            
Medical Practice Hart Not yet recruiting
Hannover, Germany, 30655
Contact: Birgit Hart     +49-511-5476390     birgit.hart@arcor.de    
Principal Investigator: Birgit Hart            
Medical Practice Menke Recruiting
Hannover, Germany, 30171
Contact: Holger Menke, MD     +49-511-851916     drhmenke@t-online.de    
Principal Investigator: Holger Menke, MD            
Medical Practice Löber Recruiting
Hardegsen, Germany, 37181
Contact: Matthias Löber, MD     +49-5505-5122     matthiasloeber@aol.com    
Principal Investigator: Matthias Löber, MD            
Sub-Investigator: Per-Christian Knöpfel            
Medical Practice Wilde Recruiting
Hildesheim, Germany, 31134
Contact: Elmar Wilde, MD     +49-5121-57774        
Principal Investigator: Elmar Wilde, MD            
Medical Practice Beverungen Recruiting
Höxter-Lüchtringen, Germany, 37671
Contact: Regina Beverungen, MD     +49-5271-97400     dr.beverungen@telemed.de    
Principal Investigator: Regina Beverungen, MD            
Medical Practice Meggers Recruiting
Langenhagen, Germany, 30855
Contact: Jörg Meggers     +49-511-743086        
Principal Investigator: Jörg Meggers            
Medical Practice Ertel Recruiting
Langwedel-Daverden, Germany, 27299
Contact: Matthias Ertel, MD     +49-4232-93260     mertel1001@aol.com    
Principal Investigator: Matthias Ertel, MD            
Medical Practice Schmitz Not yet recruiting
Neustadt am Rübenberge, Germany, 31535
Contact: Henrik Schmitz, Dr. med.     +49-5034-777     henrik.schmitz@t-online.de    
Principal Investigator: Henrik Schmitz, Dr. med.            
Medical Practice Falkenstein Recruiting
Oldenburg, Germany, 26127
Contact: Marc Falkenstein, MD     +49-441-302250     Hausarzt-Falkenstein@t-online.de    
Principal Investigator: Marc Falkenstein, MD            
Medical Practice Gemen Recruiting
Pattensen, Germany, 30982
Contact: Marion Gemen, MD     +49-5101-915459     gemen@arztpraxis-pattensen.de    
Principal Investigator: Marion Gemen, MD            
Medical Practice Preiskorn Not yet recruiting
Rehburg-Loccum, Germany, 31547
Contact: Axel Preiskorn, Dr. med.     +49-5766-96060     axel.preiskorn@t-online.de    
Principal Investigator: Axel Preiskorn, Dr. med.            
Sub-Investigator: Pamela Hilgenberg, Dr. med.            
Medical Practice Brockstedt Recruiting
Rosdorf, Germany, 37124
Contact: Kerstin Brockstedt, MD     +49-5509-2160        
Principal Investigator: Kerstin Brockstedt, MD            
Medical Practice Meier-Ahrens Recruiting
Rosdorf, Germany, 37124
Contact: Karin Meier-Ahrens, MD     +49-551-78452     karin.meier-ahrens@gmx.net    
Principal Investigator: Karin Meier-Ahrens, MD            
Sub-Investigator: Ildiko Gagyor, MD            
Medical Practice Böttcher Not yet recruiting
Schwanewede, Germany, 28790
Contact: Susanne Böttcher     +49-4209-930499     luetjen-boettcher@t-online.de    
Principal Investigator: Susanne Böttcher            
Medical Practice Fleige Recruiting
Sehnde, Germany, 31319
Contact: Thomas Fleige, MD     +49-5138-1084     thomasfleige@aol.com    
Principal Investigator: Thomas Fleige, MD            
Medical Practice Albrecht Recruiting
Springe, Germany, 31832
Contact: Frank Albrecht, MD     +49-5041972993     info@dr-albrecht-springe.de    
Principal Investigator: Frank Albrecht, MD            
Medical Practice Schmiemann Recruiting
Verden, Germany, 22283
Contact: Guido Schmiemann, MD            
Principal Investigator: Guido Schmiemann, MD            
Medical Practice Schulz Recruiting
Waake, Germany, 37136
Contact: Wolfgang Schulz     +49-5507-7148     annweiler.schweiger@web.de    
Principal Investigator: Wolfgang Schulz            
Sub-Investigator: Uta Annweiler, MD            
Medical Practice Neidhardt Not yet recruiting
Wiefelstede-Metjendorf, Germany, 26215
Contact: Holger Neidhardt     +49-441-77038-0     HolNei@yahoo.de    
Principal Investigator: Holger Neidhardt            
Medical Practice Stegemann Recruiting
Wunstorf/Luthe, Germany, 31515
Contact: Rolf Stegemann, MD     +49-5031-909030     rolf.stegemann@dga.de    
Principal Investigator: Rolf Stegemann, MD            
Sponsors and Collaborators
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
University Medical Center Goettingen
Investigators
Principal Investigator: Eva Hummers-Pradier, Prof. Abt. Allgemeinmedizin, Universitätsmedizin Göttingen, Humboldtallee 38, 37073 Göttingen
  More Information

No publications provided by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
ClinicalTrials.gov Identifier: NCT01488955     History of Changes
Other Study ID Numbers: 20110512-BG
Study First Received: December 7, 2011
Last Updated: April 24, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH:
bacterial infection

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

ClinicalTrials.gov processed this record on May 22, 2013