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| Name | Class |
|---|---|
| University Medical Center Goettingen | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibuprofen | Experimental | Ibuprofen 400 mg oral once daily from day 0 for 3 days, placebo granulate oral day 0 |
|
| Fosfomycin-Trometamol | Experimental | Fosfomycin-Trometamol (Monuril) 3 g granulate oral at day 0, placebo to Ibuprofen once a day from day 0 for 3 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen | Drug | 400 mg oral once a day from day 0 for 3 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| number of additional treatments with antibiotics combined with number of symptoms | 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. | day 0-28 |
| Measure | Description | Time Frame |
|---|---|---|
| number of defined daily doses of antibiotics | day 0-28 | |
| number of SAEs | day 0-28 | |
| number of relapses |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eva Hummers-Pradier, Prof. | Abt. Allgemeinmedizin, Universitätsmedizin Göttingen, Humboldtallee 38, 37073 Göttingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univercity Medical Center Goettingen | Göttingen | 37073 | Germany | |||
| MHH Hannover |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39698942 | Derived | 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. | |
| 26698878 | Derived | Gagyor I, Bleidorn J, Kochen MM, Schmiemann G, Wegscheider K, Hummers-Pradier E. Ibuprofen versus fosfomycin for uncomplicated urinary tract infection in women: randomised controlled trial. BMJ. 2015 Dec 23;351:h6544. doi: 10.1136/bmj.h6544. |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D005578 | Fosfomycin |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Fosfomycin-Trometamol |
| Drug |
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 |
|
|
| day 0-28 |
| number of patients without symptoms | day 4 and day 7 |
| symptom load (AUC) | day 0-4 |
| symptom load | day 0-7 |
| symptoms load with regard to specific symptoms | day 0-7 |
| activity impairment assessment | day 0-7 |
| Hanover |
| 30625 |
| Germany |
| 22742538 | Derived | Gagyor I, Hummers-Pradier E, Kochen MM, Schmiemann G, Wegscheider K, Bleidorn J. Immediate versus conditional treatment of uncomplicated urinary tract infection - a randomized-controlled comparative effectiveness study in general practices. BMC Infect Dis. 2012 Jun 28;12:146. doi: 10.1186/1471-2334-12-146. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001423 | Bacterial Infections and Mycoses |
| D063065 |
| Organophosphonates |
| D009943 | Organophosphorus Compounds |