Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
It is well known that "over-treatment" of straightforward infections should be avoided as far as possible. Evidence-based data on non antibiotic treatment options for common conditions are therefore needed urgently. This randomised-controlled double blind trial examines whether initial herbal treatment with Uva Ursi, and antibiotic treatment only if symptoms persist, reduces antibiotic consumption in uncomplicated urinary tract infections (UTI) without a negative effect on symptom course and rate of recurrent UTIs. In total, 430 patients presenting with typical UTI symptoms will be included by their GPs and receive randomised either herbal treatment with uva ursi (antibiotics only if symptoms persist), or initial antibiotic treatment. Patients record symptom severity and drug intake in a diary and complete a final questionnaire after 28 days.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Uva Ursi | Experimental | placebo to fosfomycin: 3 g granules orally 1x1 (day 0) and Uva Ursi: 105 mg (Arctuvan®) 3x2 tablets orally from day 0 for 5 days |
|
| fosfomycin | Active Comparator | fosfomycin (Monuril®): 3 g granules orally 1x1 (day 0), and placebo to Uva Ursi: 3x2 tablets orally from day 0 for 5 days If the patient returns with persistent/recurrent symptoms, antibiotic therapy according to the sensitivity test. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arctuvan | Drug | application of a herbal drug |
| |
| Fosfomycin |
| Measure | Description | Time Frame |
|---|---|---|
| antibiotic courses | number of antibiotic courses from day 0 to day 28 | day 0-28 |
| symptom burden | symptom burden (AUC) from day 0 to day 7 | day 0-7 |
| Measure | Description | Time Frame |
|---|---|---|
| early relapses | number of early relapses until day 14 | day 0-14 |
| recurrent UTI | number of recurrent UTI day 15-28 | day 15-28 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eva Hummers-Pradier, Prof. Dr. | University Medical Center Göttingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hausarztpraxis Dr. Raby | Achim | 28832 | Germany | |||
| General Practice Aden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34111592 | Derived | Gagyor I, Hummers E, Schmiemann G, Friede T, Pfeiffer S, Afshar K, Bleidorn J. Herbal treatment with uva ursi extract versus fosfomycin in women with uncomplicated urinary tract infection in primary care: a randomized controlled trial. Clin Microbiol Infect. 2021 Oct;27(10):1441-1447. doi: 10.1016/j.cmi.2021.05.032. Epub 2021 Jun 7. | |
| 29970072 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
application of an antibiotic drug |
|
| Placebo to Arctuvan | Drug | application of Placebo to Arctuvan |
|
| Placebo to Fosfomycin | Drug | application of Placebo to Fosfomycin |
|
| symptom resolution | number of patients with symptom resolution on day 4/7 | day 4 and 7 |
| symptom sum score by patients' questionnaire | mean daily symptom sum scores from day 0 to day 7; Each of the symptoms dysuria, urgency, frequency and lower abdominal pain is scored daily on a five point scale from 0 "none" to 4 "very strong" in a patients' questionnaire. | day 0-7 |
| symptom burden for dysuria | symptom burden (AUC) for dysuria scored daily on a five point scale from 0 "none" to 4 "very strong", from day 0 to day 7 | day 0-7 |
| symptom burden positive urine culture | symptom burden (AUC) day 0-7 of patients with positive urine culture | day 0-7 |
| symptom burden negative urine culture | symptom burden (AUC) day 0-7 of patients with negative urine culture | day 0-7 |
| activity impairment by UTI symptoms, measured as AUC | activity impairment by UTI symptoms (days 0-7), measured as AUC. Impairment by each UTI symptom is scored daily on a five point scale from 0 "none" to 4 "very strong". | day 0-7 |
| painkillers | use of painkillers (Defined Daily Dose (DDD) day 0-7) | day 0-7 |
| patients taking painkillers | number of patients taking painkillers | day 28 |
| antibiotic use | antibiotic use (defined daily dose (DDD) day 0-28) | day 0-28 |
| UTI related visits | number of UTI related visits day 0-28 | day 0-28 |
| UTI related sick leave | number of days of UTI related sick leave day 0-28 | day 0-28 |
| patients with poor outcome: temperature | number of patients with temperature >38°C, day 0-7, according to patients´ statement | day 0-7 |
| patients with poor outcome: worsening symptoms | number of patients with worsening symptoms (impairment in symptom score) | day 28 |
| patients with poor outcome: prolonged symptoms | number of patients with prolonged symptoms (> 7 days), day 0-28. Patients will be followed up until symptom resolution, defined as max. 1 score point on each symptom scale. | day 0-28 |
| pyelonephritis | number of pyelonephritis day 0-28, according to GP´s diagnosis | day 0-28 |
| AE and SAE | number of AE and SAE by system organ class day 0-28 | day 0-28 |
| patients with at least 1 AE/ 2 AE | proportion of patients with at least 1 AE/ 2 AE | day 28 |
| symptom burden for urgency | symptom burden (AUC) for urgency scored daily on a five point scale from 0 "none" to 4 "very strong", from day 0 to day 7 | day 0-7 |
| symptom burden for frequency | symptom burden (AUC) for frequency scored daily on a five point scale from 0 "none" to 4 "very strong", from day 0 to day 7 | day 0-7 |
| symptom burden for lower abdominal pain | symptom burden (AUC) for lower abdominal pain scored daily on a five point scale from 0 "none" to 4 "very strong", from day 0 to day 7 | day 0-7 |
| Braunschweig |
| Germany |
| General Practice Scheffer | Braunschweig | Germany |
| General Practice Coutelle | Bremen | Germany |
| General Practice Schelp | Bremen | Germany |
| General Practice Dickow | Burgwedel | Germany |
| General Practice Kiwit-Putzer | Burgwedel | Germany |
| Praxis Zietz | Celle | 29221 | Germany |
| General Practice Kutzsche | Emmerthal | Germany |
| Praxis Dr. Bahr | Gieboldehausen | 37434 | Germany |
| General Practice Müller | Gillersheim | Germany |
| Institute of General Medicine, University Medical Center Goettingen | Göttingen | 37073 | Germany |
| Praxisgemeinschaft Jacob / Kling | Göttingen | 37083 | Germany |
| General Practice Keske | Göttingen | Germany |
| General Practice Koch | Göttingen | Germany |
| General Practice Kolb | Göttingen | Germany |
| General Practice Lang | Göttingen | Germany |
| General Practice Lückerath | Göttingen | Germany |
| Praxis Dr. Egner | Hanover | 30161 | Germany |
| Institute of General Medicine, MHH Hannover | Hanover | 30625 | Germany |
| General Practice Barth | Hanover | Germany |
| General Practice Löber | Hardegsen | Germany |
| Gemeinschaftspraxis Dres Schlesier / Eckhardt | Heilbad Heiligenstadt | 37308 | Germany |
| Gemeinschaftspraxis Hartleb / Stöcking | Heilbad Heiligenstadt | 37308 | Germany |
| Praxis Dr. Koch | Heilbad Heiligenstadt | 37308 | Germany |
| Praxisgemeinschaft Seitz / Eckert | Herzberg | 37412 | Germany |
| General Practice Wilde | Hildesheim | Germany |
| Praxisgemeinschaft Stoltz / Raddatz | Höxter | 37671 | Germany |
| General Practice Beverungen | Höxter | Germany |
| Gemeinschaftspraxis Kasperczyk / Schindewolf-Lensch | Isernhagen-Süd | 30916 | Germany |
| General Practice Franz | Katlenburg-Lindau | Germany |
| Praxis Dr. Ohlendorf | Langenhagen | 30851 | Germany |
| General Practice Ertel | Langwedel | Germany |
| General Practice Wehrbein | Lemförde | Germany |
| General Practice Lindenblatt | Neustadt | Germany |
| Hausarztzentrum Nörten | Nörten-Hardenberg | 37176 | Germany |
| General Practice Preiskorn | Rehburg-Loccum | Germany |
| General Practice Meier-Ahrens | Rosdorf | Germany |
| General Practice Woitschek | Salzgitter | Germany |
| General Practice Beulshausen | Sattenhausen | Germany |
| General Practice Schulte | Scheeßel | Germany |
| General Practice Böttcher | Schwanewede | Germany |
| General Practice Albrecht | Springe | Germany |
| General Practice Wolf | Uslar | 37170 | Germany |
| General Practice Schmiemann | Verden an der Aller | Germany |
| General Practice Annweiler | Waake | Germany |
| General Practice Stegemann | Wunstorf | Germany |
| Afshar K, Fleischmann N, Schmiemann G, Bleidorn J, Hummers-Pradier E, Friede T, Wegscheider K, Moore M, Gagyor I. 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. BMC Complement Altern Med. 2018 Jul 3;18(1):203. doi: 10.1186/s12906-018-2266-x. |
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005578 | Fosfomycin |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided