Immediate vs. Conditional Use of Antibiotics in Uncomplicated Urinary Tract Infection (UTI) - ICUTI
Overview[ - collapse ][ - ]
| 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. |
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| Condition | Urinary Tract Infection |
| Intervention | Drug: Ibuprofen Drug: Fosfomycin-Trometamol |
| Phase | Phase 4 |
| Sponsor | Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH |
| Responsible Party | Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH |
| ClinicalTrials.gov Identifier | NCT01488955 |
| First Received | December 7, 2011 |
| Last Updated | June 25, 2013 |
| Last verified | June 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | December 7, 2011 |
|---|---|
| Last Updated Date | June 25, 2013 |
| Start Date | February 2012 |
| Estimated Primary Completion Date | Not Provided |
| Current 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. |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Immediate vs. Conditional Use of Antibiotics in Uncomplicated Urinary Tract Infection (UTI) - ICUTI |
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| Official Title | Immediate vs. Conditional Use of Antibiotics in Uncomplicated Urinary Tract Infection (UTI) - a Comparative Effectiveness Study in General Practice (ICUTI) |
| Brief Summary | 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
| Condition | Urinary Tract Infection |
| Intervention | Drug: Ibuprofen 400 mg oral 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 Names: Monuril |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 494 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | December 2013 |
| Eligibility 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 |
| Gender | Female |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Jutta Bleidorn, MD +49 511 532 Bleidorn.Jutta@mh-hannover.de |
| Location Countries | Germany |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01488955 |
|---|---|
| Other Study ID Numbers | 20110512-BG |
| Has Data Monitoring Committee | No |
| Information Provided By | Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH |
| Study Sponsor | Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH |
| Collaborators | University Medical Center Goettingen |
| Investigators | Principal Investigator: Eva Hummers-Pradier, Prof. Abt. Allgemeinmedizin, Universitätsmedizin Göttingen, Humboldtallee 38, 37073 Göttingen |
| Verification Date | June 2013 |
Locations[ + expand ][ + ]
| Medical Practice Hermann | Adelebsen, Germany, 37139 Contact: Cornelia Hermann, MD | +49-5506-95750 | Dr.C.Hermann@googlemail.comPrincipal Investigator: Cornelia Hermann, MD Recruiting |
|---|---|
| Medical Practice Seker | Bad Gandersheim, Germany, 37581 Contact: Güsün Seker | +49-5382-2684Principal Investigator: Güsün Seker Recruiting |
| Medical Practice Zimny | Bad Pyrmont, Germany, 31812 Contact: Hans-Hermann Zimny, Dr. med. | +49-5281-606248 | dr.zimny@t-online.dePrincipal Investigator: Hans-Hermann Zimny, Dr. med. Recruiting |
| Medical Practice Coutelle | Bremen, Germany, 28197 Contact: Alexander Coutelle, MD | +49-421-540852 | praxis@familienmedizin-bremen.dePrincipal Investigator: Alexander Coutelle, MD Recruiting |
| Medical Practice Schelp | Bremen, Germany, 28259 Contact: Holger Schelp | +49-421-5797675 | Holger-Schelp@gmx.dePrincipal Investigator: Holger Schelp Recruiting |
| Medical Practice Zedler | Bremen, Germany, 28777 Contact: Siegmar Zedler, MD | +49-421-68667 | dr.zedler@t-online.dePrincipal Investigator: Siegmar Zedler, MD Recruiting |
| Medical Practice Dickow | Burgwedel, Germany, 30938 Contact: Mona Dickow, Dr. med. | +49-5139-891929Principal Investigator: Mona Dickow, Dr. med. Recruiting |
| Medical Practice Brucker I | Destedt, Germany, 38162 Contact: Klaus Peter Brucker, MD | +49-5306-1303 | dr.brucker@t-online.dePrincipal Investigator: Klaus Peter Brucker, MD Recruiting |
| Medical Practice Rötterink | Garbsen, Germany, 30823 Contact: Hans-Hendrik Rötterink, Dr. med. | +49-5137-77788 | hendrik.roetterink@web.dePrincipal Investigator: Hans-Hendrik Rötterink, Dr. med. Recruiting |
| Medical Practice Müller | Gillersheim, Germany, 37191 Contact: Manfred Müller, Dr. med. | +49-5556-1088 | Praxis.Manfred.Mueller@t-online.dePrincipal Investigator: Manfred Müller, Dr. med. Recruiting |
| Dept. of General Medicine, Univercity Medical Center Goettingen | Goettingen, Germany, 37073 Contact: Ildiko Gagyor, MD | +49-551-3914226Principal Investigator: Ildiko Gagyor, MD Not yet recruiting |
| Medical Practice Koch | Göttingen, Germany, 37081 Contact: Thomas Koch, MD | +49-551-61700 | koch.leuckel@t-online.dePrincipal Investigator: Thomas Koch, MD Recruiting |
| Medical Practice Lückerath | Göttingen, Germany, 37077 Contact: Marianne Lückerath, MD | +49-551-24510 | mlueckerath@gmx.dePrincipal Investigator: Marianne Lückerath, MD Recruiting |
| Medical Practice Keske | Göttingen, Germany, 37081 Contact: Wolfgang Keske, MD | +49-551-91191 | wkeske@dgn.dePrincipal Investigator: Wolfgang Keske, MD Recruiting |
| Medical Practice Borchers | Hannover, Germany, 30539 Contact: Christoph Borchers, MD | +49-511-520237 | info@hausarztpraxis-bemerode.dePrincipal Investigator: Christoph Borchers, MD Recruiting |
| Dept. of General Medicine, MHH Hannover | Hannover, Germany, 30625 Contact: Jutta Bleidorn, MDPrincipal Investigator: Jutta Bleidorn, MD Not yet recruiting |
| Medical Practice Kuhlmann | Hannover, Germany, 30159 Contact: Birger Kuhlmann, MD | +49-511-2206440Principal Investigator: Birger Kuhlmann, MD Recruiting |
| Medical Practice Baumgarten | Hannover, Germany, 30419 Contact: Hans-Bernd Baumgarten, MD | +49-551-792665 | hbbaumgarten@hausarzt.dePrincipal Investigator: Hans-Bernd Baumgarten, MD Recruiting |
| Medical Practice Gosewisch | Hannover, Germany, 30659 Contact: Andrea Gosewisch, MD | +49-511-6461916 | praxis@dr-gosewisch-bothfeld.dePrincipal Investigator: Andrea Gosewisch, MD Recruiting |
| Medical Practice Glatzel | Hannover, Germany, 30163 Contact: Dirk Glatzel, MD | +49-511-638282 | Glatzel@arcor.dePrincipal Investigator: Dirk Glatzel, MD Recruiting |
| Medical Practice Dockhorn | Hannover, Germany, 30179 Contact: Uwe Dockhorn, MD | +49-511-6045979Principal Investigator: Uwe Dockhorn, MD Recruiting |
| Medical Practice Kiwit-Putzer | Hannover, Germany, 30938 Contact: Dorothee Kiwit-Putzer, MD | +49-5139-8112Principal Investigator: Dorothee Kiwit-Putzer, MD Recruiting |
| Medical Practice Buck | Hannover, Germany, 30161 Contact: Andreas Buck, MD | +49-511-312828 | DrAndreasBuck@aol.comPrincipal Investigator: Andreas Buck, MD Recruiting |
| Medical Practice Klinger-Bültemann | Hannover, Germany, 30655 Contact: Sabine Klinger-Bültemann, MD | +49-511-5477788 | klinger-bueltemann@htp-tel.dePrincipal Investigator: Sabine Klinger-Bültemann, MD Recruiting |
| Medical Practice Hart | Hannover, Germany, 30655 Contact: Birgit Hart | +49-511-5476390 | birgit.hart@arcor.dePrincipal Investigator: Birgit Hart Recruiting |
| Medical Practice Menke | Hannover, Germany, 30171 Contact: Holger Menke, MD | +49-511-851916 | drhmenke@t-online.dePrincipal Investigator: Holger Menke, MD Recruiting |
| Medical Practice Löber | Hardegsen, Germany, 37181 Contact: Matthias Löber, MD | +49-5505-5122 | matthiasloeber@aol.comPrincipal Investigator: Matthias Löber, MD Recruiting |
| Medical Practice Wilde | Hildesheim, Germany, 31134 Contact: Elmar Wilde, MD | +49-5121-57774Principal Investigator: Elmar Wilde, MD Recruiting |
| Medical Practice Beverungen | Höxter-Lüchtringen, Germany, 37671 Contact: Regina Beverungen, MD | +49-5271-97400 | dr.beverungen@telemed.dePrincipal Investigator: Regina Beverungen, MD Recruiting |
| Medical Practice Meggers | Langenhagen, Germany, 30855 Contact: Jörg Meggers | +49-511-743086Principal Investigator: Jörg Meggers Recruiting |
| Medical Practice Ertel | Langwedel-Daverden, Germany, 27299 Contact: Matthias Ertel, MD | +49-4232-93260 | mertel1001@aol.comPrincipal Investigator: Matthias Ertel, MD Recruiting |
| Medical Practice Schmitz | Neustadt am Rübenberge, Germany, 31535 Contact: Henrik Schmitz, Dr. med. | +49-5034-777 | henrik.schmitz@t-online.dePrincipal Investigator: Henrik Schmitz, Dr. med. Recruiting |
| Medical Practice Falkenstein | Oldenburg, Germany, 26127 Contact: Marc Falkenstein, MD | +49-441-302250 | Hausarzt-Falkenstein@t-online.dePrincipal Investigator: Marc Falkenstein, MD Recruiting |
| Medical Practice Gemen | Pattensen, Germany, 30982 Contact: Marion Gemen, MD | +49-5101-915459 | gemen@arztpraxis-pattensen.dePrincipal Investigator: Marion Gemen, MD Recruiting |
| Medical Practice Preiskorn | Rehburg-Loccum, Germany, 31547 Contact: Axel Preiskorn, Dr. med. | +49-5766-96060 | axel.preiskorn@t-online.dePrincipal Investigator: Axel Preiskorn, Dr. med. Recruiting |
| Medical Practice Meier-Ahrens | Rosdorf, Germany, 37124 Contact: Karin Meier-Ahrens, MD | +49-551-78452 | karin.meier-ahrens@gmx.netPrincipal Investigator: Karin Meier-Ahrens, MD Recruiting |
| Medical Practice Brockstedt | Rosdorf, Germany, 37124 Contact: Kerstin Brockstedt, MD | +49-5509-2160Principal Investigator: Kerstin Brockstedt, MD Recruiting |
| Medical Practice Böttcher | Schwanewede, Germany, 28790 Contact: Susanne Böttcher | +49-4209-930499 | luetjen-boettcher@t-online.dePrincipal Investigator: Susanne Böttcher Recruiting |
| Medical Practice Fleige | Sehnde, Germany, 31319 Contact: Thomas Fleige, MD | +49-5138-1084 | thomasfleige@aol.comPrincipal Investigator: Thomas Fleige, MD Recruiting |
| Medical Practice Albrecht | Springe, Germany, 31832 Contact: Frank Albrecht, MD | +49-5041972993 | info@dr-albrecht-springe.dePrincipal Investigator: Frank Albrecht, MD Recruiting |
| Medical Practice Schmiemann | Verden, Germany, 22283 Contact: Guido Schmiemann, MDPrincipal Investigator: Guido Schmiemann, MD Recruiting |
| Medical Practice Schulz | Waake, Germany, 37136 Contact: Wolfgang Schulz | +49-5507-7148 | annweiler.schweiger@web.dePrincipal Investigator: Wolfgang Schulz Recruiting |
| Medical Practice Schaper | Wennigsen, Germany, 30974 Contact: Miriam Schaper | +49-(0)5103-93970 | miriam.schaper@t-online.dePrincipal Investigator: Miriam Schaper Recruiting |
| Medical Practice Neidhardt | Wiefelstede-Metjendorf, Germany, 26215 Contact: Holger Neidhardt | +49-441-77038-0 | HolNei@yahoo.dePrincipal Investigator: Holger Neidhardt Recruiting |
| Medical Practice Stegemann | Wunstorf/Luthe, Germany, 31515 Contact: Rolf Stegemann, MD | +49-5031-909030 | rolf.stegemann@dga.dePrincipal Investigator: Rolf Stegemann, MD Recruiting |