Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2026-02-23 @ 12:22 PM
Study NCT ID:
NCT03151603
Status:
COMPLETED
Last Update Posted:
2019-11-27
First Post:
2017-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reducing Antibiotic Use for Uncomplicated Urinary Tract Infection in General Practice by Treatment With Uva Ursi (UU)- a Comparative Effectiveness Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014552', 'term': 'Urinary Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005578', 'term': 'Fosfomycin'}], 'ancestors': [{'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 398}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-26', 'studyFirstSubmitDate': '2017-05-10', 'studyFirstSubmitQcDate': '2017-05-10', 'lastUpdatePostDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'antibiotic courses', 'timeFrame': 'day 0-28', 'description': 'number of antibiotic courses from day 0 to day 28'}, {'measure': 'symptom burden', 'timeFrame': 'day 0-7', 'description': 'symptom burden (AUC) from day 0 to day 7'}], 'secondaryOutcomes': [{'measure': 'early relapses', 'timeFrame': 'day 0-14', 'description': 'number of early relapses until day 14'}, {'measure': 'recurrent UTI', 'timeFrame': 'day 15-28', 'description': 'number of recurrent UTI day 15-28'}, {'measure': 'symptom resolution', 'timeFrame': 'day 4 and 7', 'description': 'number of patients with symptom resolution on day 4/7'}, {'measure': "symptom sum score by patients' questionnaire", 'timeFrame': 'day 0-7', 'description': '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.'}, {'measure': 'symptom burden for dysuria', 'timeFrame': 'day 0-7', 'description': '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'}, {'measure': 'symptom burden positive urine culture', 'timeFrame': 'day 0-7', 'description': 'symptom burden (AUC) day 0-7 of patients with positive urine culture'}, {'measure': 'symptom burden negative urine culture', 'timeFrame': 'day 0-7', 'description': 'symptom burden (AUC) day 0-7 of patients with negative urine culture'}, {'measure': 'activity impairment by UTI symptoms, measured as AUC', 'timeFrame': 'day 0-7', 'description': '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".'}, {'measure': 'painkillers', 'timeFrame': 'day 0-7', 'description': 'use of painkillers (Defined Daily Dose (DDD) day 0-7)'}, {'measure': 'patients taking painkillers', 'timeFrame': 'day 28', 'description': 'number of patients taking painkillers'}, {'measure': 'antibiotic use', 'timeFrame': 'day 0-28', 'description': 'antibiotic use (defined daily dose (DDD) day 0-28)'}, {'measure': 'UTI related visits', 'timeFrame': 'day 0-28', 'description': 'number of UTI related visits day 0-28'}, {'measure': 'UTI related sick leave', 'timeFrame': 'day 0-28', 'description': 'number of days of UTI related sick leave day 0-28'}, {'measure': 'patients with poor outcome: temperature', 'timeFrame': 'day 0-7', 'description': 'number of patients with temperature \\>38°C, day 0-7, according to patients´ statement'}, {'measure': 'patients with poor outcome: worsening symptoms', 'timeFrame': 'day 28', 'description': 'number of patients with worsening symptoms (impairment in symptom score)'}, {'measure': 'patients with poor outcome: prolonged symptoms', 'timeFrame': 'day 0-28', 'description': '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.'}, {'measure': 'pyelonephritis', 'timeFrame': 'day 0-28', 'description': 'number of pyelonephritis day 0-28, according to GP´s diagnosis'}, {'measure': 'AE and SAE', 'timeFrame': 'day 0-28', 'description': 'number of AE and SAE by system organ class day 0-28'}, {'measure': 'patients with at least 1 AE/ 2 AE', 'timeFrame': 'day 28', 'description': 'proportion of patients with at least 1 AE/ 2 AE'}, {'measure': 'symptom burden for urgency', 'timeFrame': 'day 0-7', 'description': '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'}, {'measure': 'symptom burden for frequency', 'timeFrame': 'day 0-7', 'description': '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'}, {'measure': 'symptom burden for lower abdominal pain', 'timeFrame': 'day 0-7', 'description': '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'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Uva Ursi', 'fosfomycin', 'uncomplicated urinary tract infection of women'], 'conditions': ['Urinary Tract Infections']}, 'referencesModule': {'references': [{'pmid': '34111592', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '29970072', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women (18-75 years) with suspected UTI\n* at least two symptoms of UTI (dysuria, urgency of micturition, frequency, lower abdominal pain)\n* Written informed consent\n\nExclusion Criteria:\n\n* signs of complicated UTI (e. g. temperature \\> 38°C, loin tenderness)\n* conditions that may lead to complicated infections (i.e. renal diseases, patients with urinary catheter)\n* pregnancy/ breastfeeding\n* current self-medication with UU preparations e.g. z.B. Cystinol®, Uvalysat®, Arctuvan®\n* antibiotic use in the last 7 days\n* previous UTI in the past 2 weeks\n* history of pyelonephritis\n* contraindications for trial drugs\n* serious diseases\n* inability to understand trial Information\n* current participation in another clinical trial or participation in another clinical trial within the last 4 weeks'}, 'identificationModule': {'nctId': 'NCT03151603', 'acronym': 'REGATTA', 'briefTitle': 'Reducing Antibiotic Use for Uncomplicated Urinary Tract Infection in General Practice by Treatment With Uva Ursi (UU)- a Comparative Effectiveness Trial', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Goettingen'}, 'officialTitle': 'Reducing Antibiotic Use for Uncomplicated Urinary Tract Infection in General Practice by Treatment With Uva Ursi (UU)- a Comparative Effectiveness Trial', 'orgStudyIdInfo': {'id': '01579'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Uva Ursi', 'description': 'placebo to fosfomycin: 3 g granules orally 1x1 (day 0)\n\nand\n\nUva Ursi: 105 mg (Arctuvan®) 3x2 tablets orally from day 0 for 5 days', 'interventionNames': ['Drug: Arctuvan', 'Drug: Placebo to Fosfomycin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'fosfomycin', 'description': 'fosfomycin (Monuril®): 3 g granules orally 1x1 (day 0),\n\nand\n\nplacebo to Uva Ursi: 3x2 tablets orally from day 0 for 5 days\n\nIf the patient returns with persistent/recurrent symptoms, antibiotic therapy according to the sensitivity test.', 'interventionNames': ['Drug: Fosfomycin', 'Drug: Placebo to Arctuvan']}], 'interventions': [{'name': 'Arctuvan', 'type': 'DRUG', 'description': 'application of a herbal drug', 'armGroupLabels': ['Uva Ursi']}, {'name': 'Fosfomycin', 'type': 'DRUG', 'description': 'application of an antibiotic drug', 'armGroupLabels': ['fosfomycin']}, {'name': 'Placebo to Arctuvan', 'type': 'DRUG', 'description': 'application of Placebo to Arctuvan', 'armGroupLabels': ['fosfomycin']}, {'name': 'Placebo to Fosfomycin', 'type': 'DRUG', 'description': 'application of Placebo to Fosfomycin', 'armGroupLabels': ['Uva Ursi']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28832', 'city': 'Achim', 'country': 'Germany', 'facility': 'Hausarztpraxis Dr. Raby', 'geoPoint': {'lat': 53.01416, 'lon': 9.0263}}, {'city': 'Braunschweig', 'country': 'Germany', 'facility': 'General Practice Aden', 'geoPoint': {'lat': 52.26594, 'lon': 10.52673}}, {'city': 'Braunschweig', 'country': 'Germany', 'facility': 'General Practice Scheffer', 'geoPoint': {'lat': 52.26594, 'lon': 10.52673}}, {'city': 'Bremen', 'country': 'Germany', 'facility': 'General Practice Coutelle', 'geoPoint': {'lat': 53.07582, 'lon': 8.80717}}, {'city': 'Bremen', 'country': 'Germany', 'facility': 'General Practice Schelp', 'geoPoint': {'lat': 53.07582, 'lon': 8.80717}}, {'city': 'Burgwedel', 'country': 'Germany', 'facility': 'General Practice Dickow', 'geoPoint': {'lat': 53.65148, 'lon': 9.90769}}, {'city': 'Burgwedel', 'country': 'Germany', 'facility': 'General Practice Kiwit-Putzer', 'geoPoint': {'lat': 53.65148, 'lon': 9.90769}}, {'zip': '29221', 'city': 'Celle', 'country': 'Germany', 'facility': 'Praxis Zietz', 'geoPoint': {'lat': 52.62264, 'lon': 10.08047}}, {'city': 'Emmerthal', 'country': 'Germany', 'facility': 'General Practice Kutzsche', 'geoPoint': {'lat': 48.958, 'lon': 11.71844}}, {'zip': '37434', 'city': 'Gieboldehausen', 'country': 'Germany', 'facility': 'Praxis Dr. Bahr', 'geoPoint': {'lat': 51.60962, 'lon': 10.21619}}, {'city': 'Gillersheim', 'country': 'Germany', 'facility': 'General Practice Müller', 'geoPoint': {'lat': 51.63388, 'lon': 10.0924}}, {'zip': '37073', 'city': 'Göttingen', 'country': 'Germany', 'facility': 'Institute of General Medicine, University Medical Center Goettingen', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'zip': '37083', 'city': 'Göttingen', 'country': 'Germany', 'facility': 'Praxisgemeinschaft Jacob / Kling', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'city': 'Göttingen', 'country': 'Germany', 'facility': 'General Practice Keske', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'city': 'Göttingen', 'country': 'Germany', 'facility': 'General Practice Koch', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'city': 'Göttingen', 'country': 'Germany', 'facility': 'General Practice Kolb', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'city': 'Göttingen', 'country': 'Germany', 'facility': 'General Practice Lang', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'city': 'Göttingen', 'country': 'Germany', 'facility': 'General Practice Lückerath', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'zip': '30161', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Praxis Dr. Egner', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Institute of General Medicine, MHH Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Hanover', 'country': 'Germany', 'facility': 'General Practice Barth', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Hardegsen', 'country': 'Germany', 'facility': 'General Practice Löber', 'geoPoint': {'lat': 51.65227, 'lon': 9.8305}}, {'zip': '37308', 'city': 'Heilbad Heiligenstadt', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis Dres Schlesier / Eckhardt', 'geoPoint': {'lat': 51.37819, 'lon': 10.13744}}, {'zip': '37308', 'city': 'Heilbad Heiligenstadt', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis Hartleb / Stöcking', 'geoPoint': {'lat': 51.37819, 'lon': 10.13744}}, {'zip': '37308', 'city': 'Heilbad Heiligenstadt', 'country': 'Germany', 'facility': 'Praxis Dr. Koch', 'geoPoint': {'lat': 51.37819, 'lon': 10.13744}}, {'zip': '37412', 'city': 'Herzberg', 'country': 'Germany', 'facility': 'Praxisgemeinschaft Seitz / Eckert', 'geoPoint': {'lat': 51.68692, 'lon': 13.22016}}, {'city': 'Hildesheim', 'country': 'Germany', 'facility': 'General Practice Wilde', 'geoPoint': {'lat': 52.15077, 'lon': 9.95112}}, {'zip': '37671', 'city': 'Höxter', 'country': 'Germany', 'facility': 'Praxisgemeinschaft Stoltz / Raddatz', 'geoPoint': {'lat': 51.77501, 'lon': 9.38155}}, {'city': 'Höxter', 'country': 'Germany', 'facility': 'General Practice Beverungen', 'geoPoint': {'lat': 51.77501, 'lon': 9.38155}}, {'zip': '30916', 'city': 'Isernhagen-Süd', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis Kasperczyk / Schindewolf-Lensch', 'geoPoint': {'lat': 52.43819, 'lon': 9.79871}}, {'city': 'Katlenburg-Lindau', 'country': 'Germany', 'facility': 'General Practice Franz', 'geoPoint': {'lat': 51.68333, 'lon': 10.1}}, {'zip': '30851', 'city': 'Langenhagen', 'country': 'Germany', 'facility': 'Praxis Dr. Ohlendorf', 'geoPoint': {'lat': 52.44758, 'lon': 9.73741}}, {'city': 'Langwedel', 'country': 'Germany', 'facility': 'General Practice Ertel', 'geoPoint': {'lat': 52.97864, 'lon': 9.18542}}, {'city': 'Lemförde', 'country': 'Germany', 'facility': 'General Practice Wehrbein', 'geoPoint': {'lat': 52.46557, 'lon': 8.37621}}, {'city': 'Neustadt', 'country': 'Germany', 'facility': 'General Practice Lindenblatt', 'geoPoint': {'lat': 53.55196, 'lon': 9.98558}}, {'zip': '37176', 'city': 'Nörten-Hardenberg', 'country': 'Germany', 'facility': 'Hausarztzentrum Nörten', 'geoPoint': {'lat': 51.62878, 'lon': 9.93593}}, {'city': 'Rehburg-Loccum', 'country': 'Germany', 'facility': 'General Practice Preiskorn', 'geoPoint': {'lat': 52.46952, 'lon': 9.19957}}, {'city': 'Rosdorf', 'country': 'Germany', 'facility': 'General Practice Meier-Ahrens', 'geoPoint': {'lat': 51.5, 'lon': 9.9}}, {'city': 'Salzgitter', 'country': 'Germany', 'facility': 'General Practice Woitschek', 'geoPoint': {'lat': 52.15705, 'lon': 10.4154}}, {'city': 'Sattenhausen', 'country': 'Germany', 'facility': 'General Practice Beulshausen', 'geoPoint': {'lat': 51.5057, 'lon': 10.09793}}, {'city': 'Scheeßel', 'country': 'Germany', 'facility': 'General Practice Schulte', 'geoPoint': {'lat': 53.16872, 'lon': 9.48261}}, {'city': 'Schwanewede', 'country': 'Germany', 'facility': 'General Practice Böttcher', 'geoPoint': {'lat': 53.22398, 'lon': 8.58969}}, {'city': 'Springe', 'country': 'Germany', 'facility': 'General Practice Albrecht', 'geoPoint': {'lat': 52.20845, 'lon': 9.55416}}, {'zip': '37170', 'city': 'Uslar', 'country': 'Germany', 'facility': 'General Practice Wolf', 'geoPoint': {'lat': 51.6569, 'lon': 9.63501}}, {'city': 'Verden an der Aller', 'country': 'Germany', 'facility': 'General Practice Schmiemann', 'geoPoint': {'lat': 52.92343, 'lon': 9.23491}}, {'city': 'Waake', 'country': 'Germany', 'facility': 'General Practice Annweiler', 'geoPoint': {'lat': 51.55637, 'lon': 10.05713}}, {'city': 'Wunstorf', 'country': 'Germany', 'facility': 'General Practice Stegemann', 'geoPoint': {'lat': 52.42377, 'lon': 9.43585}}], 'overallOfficials': [{'name': 'Eva Hummers-Pradier, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Göttingen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Goettingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Quality Assurance Staff Unit Clinical Trials', 'investigatorFullName': 'Karsten Gavenis', 'investigatorAffiliation': 'University Medical Center Goettingen'}}}}