Gágyor, Ildikó

[["dc.bibliographiccitation.artnumber","30"],["dc.bibliographiccitation.journal","BMC Medicine"],["dc.bibliographiccitation.volume","8"],["dc.contributor.author","Bleidorn, Jutta"],["dc.contributor.author","Gagyor, Ildiko"],["dc.contributor.author","Kochen, Michael M."],["dc.contributor.author","Wegscheider, Karl"],["dc.contributor.author","Hummers-Pradier, Eva"],["dc.date.accessioned","2018-11-07T08:43:08Z"],["dc.date.available","2018-11-07T08:43:08Z"],["dc.date.issued","2010"],["dc.description.abstract","Background: Uncomplicated lower urinary tract infections (UTI) are usually treated with antibiotics. However, there is little evidence for alternative therapeutic options. This pilot study was set out 1) to make a rough estimate of the equivalence of ibuprofen and ciprofloxacin for uncomplicated urinary tract infection with regard to symptom resolution, and 2) to demonstrate the feasibility of a double-blind, randomized controlled drug trial in German general practices. Methods: We performed a double-blind, randomized controlled pilot trial in 29 German general practices. Eighty otherwise healthy women aged 18 to 85 years, presenting with at least one of the main UTI symptoms dysuria and frequency and without any complicating factors, were randomly assigned to receive either ibuprofen 3 x 400 mg oral or ciprofloxacin 2 x 250 mg (+1 placebo) oral, both for three days. Intensity of main symptoms-dysuria, frequency, low abdominal pain-was recorded at inclusion and after 4, 7 and 28 days, scoring each symptom from 0 (none) to 4 (very strong). The primary endpoint was symptom resolution on Day 4. Secondary outcomes were the burden of symptoms on Days 4 and 7 (based on the sum score of all symptoms), symptom resolution on Day 7 and frequency of relapses. Equivalence margins for symptom burden on Day 4 were pre-specified as +/-0.5 sum score points. Data analysis was done by intention to treat and per protocol. Randomization was carried out on patient level by computer programme in blocks of six. Results: Seventy-nine patients were analyzed (ibuprofen n = 40, ciprofloxacin n = 39). On Day 4, 21/36 (58.3%) of patients in the ibuprofen-group were symptom-free versus 17/33 (51.5%) in the ciprofloxacin-group. On Day 4, ibuprofen patients reported fewer symptoms in terms of total sum score (1; SD 1,42) than ciprofloxacin patients (1,3; SD 1,9), difference-0,33 (95% CI (-1,13 to + 0,47)), PP (per protocol) analysis. During Days 0 and 9, 12/36 (33%) of patients in the ibuprofen-group received secondary antibiotic treatment due to ongoing or worsening symptoms, compared to 6/33 (18%) in the ciprofloxacin-group (non significant). A total of 58 non-serious adverse events were reported, 32 in the ibuprofen group versus 26 in the ciprofloxacin group (non significant). Conclusions: Our results support the assumption of non-inferiority of ibuprofen compared to ciprofloxacin for treatment of symptomatic uncomplicated UTI, but need confirmation by further trials."],["dc.identifier.doi","10.1186/1741-7015-8-30"],["dc.identifier.isi","000279916700001"],["dc.identifier.pmid","20504298"],["dc.identifier.purl","https://resolver.sub.uni-goettingen.de/purl?gs-1/5676"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/19886"],["dc.notes.intern","Merged from goescholar"],["dc.notes.status","zu prüfen"],["dc.notes.submitter","Najko"],["dc.relation.issn","1741-7015"],["dc.relation.orgunit","Institut für Allgemeinmedizin"],["dc.rights","CC BY 2.0"],["dc.rights.uri","https://creativecommons.org/licenses/by/2.0"],["dc.title","Symptomatic treatment (ibuprofen) or antibiotics (ciprofloxacin) for uncomplicated urinary tract infection? - Results of a randomized controlled pilot trial"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dc.type.peerReviewed","yes"],["dc.type.subtype","original_ja"],["dc.type.version","published_version"],["dspace.entity.type","Publication"]]

[["dc.bibliographiccitation.firstpage","E234"],["dc.bibliographiccitation.issue","645"],["dc.bibliographiccitation.journal","British Journal of General Practice"],["dc.bibliographiccitation.lastpage","E240"],["dc.bibliographiccitation.volume","66"],["dc.contributor.author","Gágyor, Ildikó"],["dc.contributor.author","Haasenritter, Jörg"],["dc.contributor.author","Bleidorn, Jutta"],["dc.contributor.author","McIsaac, Warren"],["dc.contributor.author","Schmiemann, Guido"],["dc.contributor.author","Hummers-Pradier, Eva"],["dc.contributor.author","Himmel, Wolfgang"],["dc.date.accessioned","2020-12-10T18:47:26Z"],["dc.date.available","2020-12-10T18:47:26Z"],["dc.date.issued","2016"],["dc.description.abstract","Background Uncomplicated urinary tract infection (UTI) is often treated with antibiotics, resulting in increasing resistance levels. A randomised controlled trial showed that two-thirds of females with UTI treated symptomatically recovered without subsequent antibiotic treatment. Aim To investigate whether there are differences between females with a UTI who were subsequently prescribed antibiotics and those who recovered with symptomatic treatment only, and to develop a model to predict those who can safely and effectively be treated symptomatically. Design and setting This is a subgroup analysis of females assigned to ibuprofen in a UTI trial in general practices. Method Multiple logistic regression analysis was used to select variables for a prediction model, The discriminative value of the model was estimated by the area under the receiver operator curve (AUC) and the effects of different thresholds were calculated within the model predicting antibiotic prescription and need for follow-up visits. Results Of the 235 females in the ibuprofen group, 79 were subsequently prescribed antibiotics within 28 days of follow-up. The final model included five predictors: urgency/frequency, impaired daily activities, and positive dipstick test results for erythrocytes, leucocytes, and nitrite. The AUC was 0.73 (95% CI = 0.67 to 0.80). A reasonable threshold for antibiotic initiation would result in 58% of females presenting with UTI being treated with antibiotics. Of the remaining females, only 6% would return to the practice because of symptomatic treatment failure. Conclusion The present model revealed moderately good accuracy and could be the basis for a decision aid for GPs and females to find the treatment option that fits best."],["dc.identifier.doi","10.3399/bjgp16X684361"],["dc.identifier.isi","000376585200002"],["dc.identifier.pmid","26965031"],["dc.identifier.purl","https://resolver.sub.uni-goettingen.de/purl?gs-1/14110"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/78763"],["dc.language.iso","en"],["dc.notes.intern","DOI Import GROB-354"],["dc.notes.intern","Merged from goescholar"],["dc.notes.status","zu prüfen"],["dc.notes.submitter","Najko"],["dc.relation.issn","1478-5242"],["dc.relation.issn","0960-1643"],["dc.relation.orgunit","Institut für Allgemeinmedizin"],["dc.rights","CC BY-NC 3.0"],["dc.rights.uri","https://creativecommons.org/licenses/by-nc/3.0"],["dc.title","Predicting antibiotic prescription after symptomatic treatment for urinary tract infection: development of a model using data from an RCT in general practice"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dc.type.peerReviewed","yes"],["dc.type.subtype","original_ja"],["dc.type.version","published_version"],["dspace.entity.type","Publication"]]

[["dc.bibliographiccitation.artnumber","38"],["dc.bibliographiccitation.issue","1"],["dc.bibliographiccitation.journal","Research Involvement and Engagement"],["dc.bibliographiccitation.volume","5"],["dc.contributor.author","Schilling, Imke"],["dc.contributor.author","Behrens, Heike"],["dc.contributor.author","Bleidorn, Jutta"],["dc.contributor.author","Gágyor, Ildikó"],["dc.contributor.author","Hugenschmidt, Claudia"],["dc.contributor.author","Jilani, Hannah"],["dc.contributor.author","Schmiemann, Guido"],["dc.contributor.author","Gerhardus, Ansgar"],["dc.date.accessioned","2019-12-01T04:26:32Z"],["dc.date.accessioned","2021-10-27T13:21:39Z"],["dc.date.available","2019-12-01T04:26:32Z"],["dc.date.available","2021-10-27T13:21:39Z"],["dc.date.issued","2019"],["dc.date.updated","2019-12-01T04:26:32Z"],["dc.description.abstract","Background Patient and public involvement (PPI) has become an essential part of the design, conduct, and dissemination of research. While researchers who employed PPI mainly report on the positive aspects, in practice PPI is still an exception in clinical trials in Germany. There are specific challenges in the process of involvement that can jeopardize the conduct of involvement. The aim of our study was to analyze the experience of patients and researchers with PPI in a clinical trial in Germany, so we could learn more about potential challenges and how they could be addressed. Methods We established a patient board for a randomized controlled trial on urinary tract infections, where patients and researchers regularly met to discuss relevant aspects of the trial. Minutes were taken for each meeting and the moderator also noted her observations in a postscript. After four meetings, we conducted two focus groups, one each with the patients and researchers. We analyzed and categorized the minutes, postscripts, and focus group transcripts using thematic qualitative text analysis. Results Patients and researchers felt comfortable with the composition of the patient board and its’ atmosphere. In terms of challenges, patients and researchers needed time to get familiar with PPI. Both parties saw a need for training in PPI but differed in their views on the relevant topics. Patients wished to learn more about their role and tasks within the board at the onset of the PPI. They also preferred to meet more frequently and get more intensely involved in the trial. In contrast, researchers perceived that they were already highly involved. They further felt that the involvement was of benefit to them, the trial and future research. Patients described benefits for themselves, but also wondered if their involvement had had an impact on the trial. Conclusions To facilitate effective PPI, resources, adequate structures, and training are needed. Patients and researchers need to agree on their respective roles, training needs, and the mode of cooperation right at the beginning. The parties involved should continuously reflect on the actual benefits of PPI, describe them explicitly and make them transparent for all."],["dc.identifier.doi","10.1186/s40900-019-0172-0"],["dc.identifier.pmid","31798964"],["dc.identifier.purl","https://resolver.sub.uni-goettingen.de/purl?gs-1/16761"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/92038"],["dc.language.iso","en"],["dc.notes.intern","Migrated from goescholar"],["dc.relation.orgunit","Universitätsmedizin Göttingen"],["dc.rights","CC0 1.0 Universal"],["dc.rights.holder","The Author(s)."],["dc.rights.uri","https://creativecommons.org/licenses/by/4.0"],["dc.title","Patients’ and researchers’ experiences with a patient board for a clinical trial on urinary tract infections"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dc.type.subtype","original_ja"],["dc.type.version","published_version"],["dspace.entity.type","Publication"]]

[["dc.bibliographiccitation.artnumber","33"],["dc.bibliographiccitation.journal","BMC Urology"],["dc.bibliographiccitation.volume","12"],["dc.contributor.author","Schmiemann, Guido"],["dc.contributor.author","Gágyor, Ildikó"],["dc.contributor.author","Hummers-Pradier, Eva"],["dc.contributor.author","Bleidorn, Jutta"],["dc.date.accessioned","2018-11-07T09:03:17Z"],["dc.date.available","2018-11-07T09:03:17Z"],["dc.date.issued","2012"],["dc.description.abstract","Background: Guideline recommendations on therapy in urinary tract infections are based on antibiotic resistance rates. Due to a lack of surveillance data, little is known about resistance rates in uncomplicated urinary tract infection (UTI) in general practice in Germany. In a prospective observational study, urine cultures of all women presenting with urinary tract infections in general practice were analysed. Resistance rates against antibiotics recommended in German guidelines on UTI are presented. Methods: In a prospective, multi-center observational study general practitioner included all female patients >= 18 years with clinically suspected urinary tract infection. Only patients receiving an antibiotic therapy within the last two weeks were excluded. Results: 40 practices recruited 191 female patients (mean age 52 years; range 18-96) with urinary tract infections. Main causative agent was Escherichia coli (79%) followed by Enterococcus faecalis (14%) and Klebsiella pneumoniae (7.3%). Susceptibiliy of E. coli as the main causative agent was highest against fosfomycin and nitrofurantoin, with low resistance rates of 4,5%; 2,2%. In 17,5%, E. coli was resistant to trimethoprim and in 8,5% to ciprofloxacin. Conclusions: Resistance rates of uropathogens from unselected patients in general practice differ from routinely collected laboratory data. These results can have an impact on antibiotic prescribing and treatment recommendations."],["dc.identifier.doi","10.1186/1471-2490-12-33"],["dc.identifier.isi","000313245000001"],["dc.identifier.pmid","23171154"],["dc.identifier.purl","https://resolver.sub.uni-goettingen.de/purl?gs-1/8468"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/24875"],["dc.notes.intern","Merged from goescholar"],["dc.notes.status","zu prüfen"],["dc.notes.submitter","Najko"],["dc.relation.issn","1471-2490"],["dc.relation.orgunit","Institut für Allgemeinmedizin"],["dc.rights","CC BY 2.0"],["dc.rights.uri","https://creativecommons.org/licenses/by/2.0"],["dc.title","Resistance profiles of urinary tract infections in general practice - an observational study"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dc.type.peerReviewed","yes"],["dc.type.subtype","original_ja"],["dc.type.version","published_version"],["dspace.entity.type","Publication"]]

[["dc.bibliographiccitation.artnumber","91"],["dc.bibliographiccitation.journal","Trials"],["dc.bibliographiccitation.volume","12"],["dc.contributor.author","Gágyor, Ildikó"],["dc.contributor.author","Bleidorn, Jutta"],["dc.contributor.author","Wegscheider, Karl"],["dc.contributor.author","Hummers-Pradier, Eva"],["dc.contributor.author","Kochen, Michael M."],["dc.date.accessioned","2018-11-07T08:57:23Z"],["dc.date.available","2018-11-07T08:57:23Z"],["dc.date.issued","2011"],["dc.description.abstract","Background: Randomised controlled clinical (drug) trials supply high quality evidence for therapeutic strategies in primary care. Until now, experience with drug trials in German general practice has been sparse. In 2007/2008, the authors conducted an investigator-initiated, non-commercial, double-blind, randomised controlled pilot trial (HWI-01) to assess the clinical equivalence of ibuprofen and ciprofloxacin in the treatment of uncomplicated urinary tract infection (UTI). Here, we report the feasibility of this trial in German general practices and the implementation of Good Clinical Practice (GCP) standards as defined by the International Conference on Harmonisation (ICH) in mainly inexperienced general practices. Methods: This report is based on the experience of the HWI-01 study conducted in 29 German general practices. Feasibility was defined by 1) successful practice recruitment, 2) sufficient patient recruitment, 3) complete and accurate data collection and 4) appropriate protection of patient safety. Results: The final practice recruitment rate was 18%. In these practices, 79 of 195 screened UTI patients were enrolled. Recruitment differed strongly between practices (range 0-12, mean 2.8 patients per practice) and was below the recruitment goal of approximately 100 patients. As anticipated, practice nurses became the key figures in the screening und recruitment of patients. Clinical trial demands, in particular for completing symptom questionnaires, documentation of source data and reporting of adverse events, did not agree well with GPs' documentation habits and required support from study nurses. In many cases, GPs and practice staff seemed to be overwhelmed by the amount of information and regulations. No sudden unexpected serious adverse reactions (SUSARs) were observed during the trial. Conclusions: To enable drug trials in general practice, it is necessary to adapt the setup of clinical research infrastructure to the needs of GPs and their practice staff. Risk adaption of clinical trial regulations is necessary to facilitate non-commercial comparative effectiveness trials in primary health care."],["dc.description.sponsorship","German Ministry of Research and Technology [01GK 0501]"],["dc.identifier.doi","10.1186/1745-6215-12-91"],["dc.identifier.isi","000289695600001"],["dc.identifier.pmid","21457558"],["dc.identifier.purl","https://resolver.sub.uni-goettingen.de/purl?gs-1/6216"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/23390"],["dc.notes.intern","Merged from goescholar"],["dc.notes.status","zu prüfen"],["dc.notes.submitter","Najko"],["dc.relation.issn","1745-6215"],["dc.relation.orgunit","Institut für Allgemeinmedizin"],["dc.rights","CC BY 2.0"],["dc.rights.uri","https://creativecommons.org/licenses/by/2.0"],["dc.title","Practices, patients and (im)perfect data - feasibility of a randomised controlled clinical drug trial in German general practices"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dc.type.peerReviewed","yes"],["dc.type.subtype","original_ja"],["dc.type.version","published_version"],["dspace.entity.type","Publication"]]

[["dc.bibliographiccitation.artnumber","203"],["dc.bibliographiccitation.issue","1"],["dc.bibliographiccitation.journal","BMC Complementary and Alternative Medicine"],["dc.bibliographiccitation.volume","18"],["dc.contributor.author","Afshar, Kambiz"],["dc.contributor.author","Fleischmann, Nina"],["dc.contributor.author","Schmiemann, Guido"],["dc.contributor.author","Bleidorn, Jutta"],["dc.contributor.author","Hummers-Pradier, Eva"],["dc.contributor.author","Friede, Tim"],["dc.contributor.author","Wegscheider, Karl"],["dc.contributor.author","Moore, Michael"],["dc.contributor.author","Gágyor, Ildikó"],["dc.date.accessioned","2019-07-09T11:45:32Z"],["dc.date.available","2019-07-09T11:45:32Z"],["dc.date.issued","2018"],["dc.description.abstract","BACKGROUND: Uncomplicated urinary tract infections (UTI) are common in general practice and usually treated with antibiotics. This contributes to increasing resistance rates of uropathogenic bacteria. A previous trial showed a reduction of antibiotic use in women with UTI by initial symptomatic treatment with ibuprofen. However, this treatment strategy is not suitable for all women equally. Arctostaphylos uva-ursi (UU, bearberry extract arbutin) is a potential alternative treatment. This study aims at investigating whether an initial treatment with UU in women with UTI can reduce antibiotic use without significantly increasing the symptom burden or rate of complications. METHODS: This is a double-blind, randomized, and controlled comparative effectiveness trial. Women between 18 and 75 years with suspected UTI and at least two of the symptoms dysuria, urgency, frequency or lower abdominal pain will be assessed for eligibility in general practice and enrolled into the trial. Participants will receive either a defined daily dose of 3 × 2 arbutin 105 mg for 5 days (intervention) or fosfomycin 3 g once (control). Antibiotic therapy will be provided in the intervention group only if needed, i.e. for women with worsening or persistent symptoms. Two co-primary outcomes are the number of all antibiotic courses regardless of the medical indication from day 0-28, and the symptom burden, defined as a weighted sum of the daily total symptom scores from day 0-7. The trial result is considered positive if superiority of initial treatment with UU is demonstrated with reference to the co-primary outcome number of antibiotic courses and non-inferiority of initial treatment with UU with reference to the co-primary outcome symptom burden. DISCUSSION: The trial's aim is to investigate whether initial treatment with UU is a safe and effective alternative treatment strategy in women with UTI. In that case, the results might change the existing treatment strategy in general practice by promoting delayed prescription of antibiotics and a reduction of antibiotic use in primary care."],["dc.identifier.doi","10.1186/s12906-018-2266-x"],["dc.identifier.pmid","29970072"],["dc.identifier.purl","https://resolver.sub.uni-goettingen.de/purl?gs-1/15242"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/59254"],["dc.language.iso","en"],["dc.notes.intern","Merged from goescholar"],["dc.relation.orgunit","Institut für Allgemeinmedizin"],["dc.relation.orgunit","Institut für Medizinische Statistik"],["dc.rights","CC BY 4.0"],["dc.rights.uri","https://goescholar.uni-goettingen.de/licenses"],["dc.title","Reducing antibiotic use for uncomplicated urinary tract infection in general practice by treatment with uva-ursi (REGATTA) – a double-blind, randomized, controlled comparative effectiveness trial"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dc.type.subtype","original_ja"],["dc.type.version","published_version"],["dspace.entity.type","Publication"]]

[["dc.bibliographiccitation.artnumber","h6544"],["dc.bibliographiccitation.journal","The BMJ"],["dc.bibliographiccitation.volume","351"],["dc.contributor.author","Gágyor, Ildikó"],["dc.contributor.author","Bleidorn, Jutta"],["dc.contributor.author","Kochen, Michael M."],["dc.contributor.author","Schmiemann, Guido"],["dc.contributor.author","Wegscheider, Karl"],["dc.contributor.author","Hummers-Pradier, Eva"],["dc.date.accessioned","2019-07-10T08:11:57Z"],["dc.date.available","2019-07-10T08:11:57Z"],["dc.date.issued","2015"],["dc.description.abstract","STUDY QUESTION:  Can treatment of the symptoms of uncomplicated urinary tract infection (UTI) with ibuprofen reduce the rate of antibiotic prescriptions without a significant increase in symptoms, recurrences, or complications? METHODS:  Women aged 18-65 with typical symptoms of UTI and without risk factors or complications were recruited in 42 German general practices and randomly assigned to treatment with a single dose of fosfomycin 3 g (n=246; 243 analysed) or ibuprofen 3×400 mg (n=248; 241 analysed) for three days (and the respective placebo dummies in both groups). In both groups additional antibiotic treatment was subsequently prescribed as necessary for persistent, worsening, or recurrent symptoms. The primary endpoints were the number of all courses of antibiotic treatment on days 0-28 (for UTI or other conditions) and burden of symptoms on days 0-7. The symptom score included dysuria, frequency/urgency, and low abdominal pain. STUDY ANSWER AND LIMITATIONS:  The 248 women in the ibuprofen group received significantly fewer course of antibiotics, had a significantly higher total burden of symptoms, and more had pyelonephritis. Four serious adverse events occurred that lead to hospital referrals; one of these was potentially related to the trial drug. Results have to be interpreted carefully as they might apply to women with mild to moderate symptoms rather than to all those with an uncomplicated UTI. WHAT THIS PAPER ADDS:  Two thirds of women with uncomplicated UTI treated symptomatically with ibuprofen recovered without any antibiotics. Initial symptomatic treatment is a possible approach to be discussed with women willing to avoid immediate antibiotics and to accept a somewhat higher burden of symptoms. FUNDING, COMPETING INTERESTS, DATA SHARING:  German Federal Ministry of Education and Research (BMBF) No 01KG1105. Patient level data are available from the corresponding author. Patient consent was not obtained but the data are anonymised and risk of identification is low.Trial registration No ClinicalTrialGov Identifier NCT01488955."],["dc.identifier.doi","10.1136/bmj.h6544"],["dc.identifier.pmid","26698878"],["dc.identifier.purl","https://resolver.sub.uni-goettingen.de/purl?gs-1/12756"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/60828"],["dc.language.iso","en"],["dc.relation.issn","1756-1833"],["dc.relation.orgunit","Institut für Allgemeinmedizin"],["dc.rights","CC BY-NC 3.0"],["dc.rights.uri","https://creativecommons.org/licenses/by-nc/3.0"],["dc.title","Ibuprofen versus fosfomycin for uncomplicated urinary tract infection in women: randomised controlled trial"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dc.type.subtype","original_ja"],["dc.type.version","published_version"],["dspace.entity.type","Publication"]]

[["dc.bibliographiccitation.artnumber","146"],["dc.bibliographiccitation.journal","BMC Infectious Diseases"],["dc.bibliographiccitation.volume","12"],["dc.contributor.author","Gágyor, Ildikó"],["dc.contributor.author","Hummers-Pradier, Eva"],["dc.contributor.author","Kochen, Michael M."],["dc.contributor.author","Schmiemann, Guido"],["dc.contributor.author","Wegscheider, Karl"],["dc.contributor.author","Bleidorn, Jutta"],["dc.date.accessioned","2018-11-07T09:09:09Z"],["dc.date.available","2018-11-07T09:09:09Z"],["dc.date.issued","2012"],["dc.description.abstract","Background: Uncomplicated urinary tract infections (UTI) are usually treated with antibiotics as recommended by primary care guidelines. Antibiotic treatment supports clinical cure in individual patients but also leads to emerging resistance rates in the population. We designed a comparative effectiveness study to investigate whether the use of antibiotics for uncomplicated UTI could be reduced by initial treatment with ibuprofen, reserving antibiotic treatment to patients who return due to ongoing or recurrent symptoms. Methods/design: This is a randomized-controlled, double-blind, double dummy multicentre trial assessing the comparative effectiveness of immediate vs. conditional antibiotic therapy in uncomplicated UTI. Women > 18 and < 65 years, presenting at general practices with at least one of the typical symptoms dysuria or frequency/urgency of micturition, will be screened and enrolled into the trial. During an 18-months recruitment period, a total of 494 patients will have to be recruited in 45 general practices in Lower Saxony. Participating patients receive either immediate antibiotic therapy with fosfomycin-trometamol 1x3g or initial symptomatic treatment with ibuprofen 3x400mg for 3 days. The ibuprofen group will be provided with antibiotic therapy only if needed, i.e. for persistent or worsening symptoms. For a combined primary endpoint, we choose the number of all antibiotic prescriptions regardless of the medical indication day 0-28 and the \"disease burden\", defined as a weighted sum of the daily total symptom scores from day 0 to day 7. The study is considered positive if superiority of conditional antibiotic treatment with respect to the first primary endpoint and non-inferiority of conditional antibiotic treatment with respect to the second primary endpoint is proven. Discussion: This study aims at investigating whether the use of antibiotics for uncomplicated UTI could be reduced by initial treatment with ibuprofen. The comparative effectiveness design was chosen to prove the effectiveness of two therapeutic strategies instead of the pure drug efficacy."],["dc.description.sponsorship","Open-Access-Publikationsfonds 2012"],["dc.identifier.doi","10.1186/1471-2334-12-146"],["dc.identifier.isi","000307225600001"],["dc.identifier.pmid","22742538"],["dc.identifier.purl","https://resolver.sub.uni-goettingen.de/purl?gs-1/7849"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/26192"],["dc.notes.intern","Merged from goescholar"],["dc.notes.status","zu prüfen"],["dc.notes.submitter","Najko"],["dc.relation.issn","1471-2334"],["dc.relation.orgunit","Institut für Allgemeinmedizin"],["dc.rights","CC BY 2.0"],["dc.rights.uri","https://creativecommons.org/licenses/by/2.0"],["dc.title","Immediate versus conditional treatment of uncomplicated urinary tract infection - a randomized-controlled comparative effectiveness study in general practices"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dc.type.peerReviewed","yes"],["dc.type.subtype","original_ja"],["dc.type.version","published_version"],["dspace.entity.type","Publication"]]