Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-04-24 @ 12:50 AM
Study NCT ID:
NCT03221504
Status:
UNKNOWN
Last Update Posted:
2018-03-20
First Post:
2017-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
7-day Compared With 10-day Antibiotic Treatment for Febrile Urinary Tract Infections in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014552', 'term': 'Urinary Tract Infections'}, {'id': 'D011704', 'term': 'Pyelonephritis'}], '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'}, {'id': 'D009395', 'term': 'Nephritis, Interstitial'}, {'id': 'D009393', 'term': 'Nephritis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D011702', 'term': 'Pyelitis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 221}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2020-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-19', 'studyFirstSubmitDate': '2017-07-07', 'studyFirstSubmitQcDate': '2017-07-14', 'lastUpdatePostDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'frequencies of recurrence of UTI', 'timeFrame': '3 months after intervention', 'description': 'New onset of symptomatic UTI within the 3 months follow-up period. The recurrence of a UTI is diagnosed when the next infection is caused by the same microorganism during 3 months following the treatment of a UTI.'}], 'secondaryOutcomes': [{'measure': 'frequencies of reinfection of UTI', 'timeFrame': '6 months after intervention', 'description': 'The reinfection of a UTI is diagnosed when the next infection is caused by a different bacteria.'}, {'measure': 'antibiotic-associated diarrhoea (AAD), compliance', 'timeFrame': '7 days after intervention', 'description': 'AAD is defined by the daily production of at least 3 loose or watery stools for at least 48 hours during antibiotic treatment and 7 days after administration of the antibiotic.\n\nCompliance with the study protocol will be assessed by direct interview with the patient and/or caregiver and by measuring the amount of the fluid left in the bottle at the end of the intervention.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['urinary tract infections', 'pyelonephritis', 'cefuroxime', 'children'], 'conditions': ['Urinary Tract Infections in Children']}, 'referencesModule': {'references': [{'pmid': '26361319', 'type': 'BACKGROUND', 'citation': 'Simoes e Silva AC, Oliveira EA. Update on the approach of urinary tract infection in childhood. J Pediatr (Rio J). 2015 Nov-Dec;91(6 Suppl 1):S2-10. doi: 10.1016/j.jped.2015.05.003. Epub 2015 Sep 7.'}, {'pmid': '17622599', 'type': 'BACKGROUND', 'citation': 'Conway PH, Cnaan A, Zaoutis T, Henry BV, Grundmeier RW, Keren R. Recurrent urinary tract infections in children: risk factors and association with prophylactic antimicrobials. JAMA. 2007 Jul 11;298(2):179-86. doi: 10.1001/jama.298.2.179.'}, {'pmid': '19864673', 'type': 'BACKGROUND', 'citation': 'Craig JC, Simpson JM, Williams GJ, Lowe A, Reynolds GJ, McTaggart SJ, Hodson EM, Carapetis JR, Cranswick NE, Smith G, Irwig LM, Caldwell PH, Hamilton S, Roy LP; Prevention of Recurrent Urinary Tract Infection in Children with Vesicoureteric Reflux and Normal Renal Tracts (PRIVENT) Investigators. Antibiotic prophylaxis and recurrent urinary tract infection in children. N Engl J Med. 2009 Oct 29;361(18):1748-59. doi: 10.1056/NEJMoa0902295.'}, {'pmid': '21873693', 'type': 'BACKGROUND', 'citation': 'Subcommittee on Urinary Tract Infection, Steering Committee on Quality Improvement and Management; Roberts KB. Urinary tract infection: clinical practice guideline for the diagnosis and management of the initial UTI in febrile infants and children 2 to 24 months. Pediatrics. 2011 Sep;128(3):595-610. doi: 10.1542/peds.2011-1330. Epub 2011 Aug 28.'}, {'pmid': '17611232', 'type': 'BACKGROUND', 'citation': "Montini G, Toffolo A, Zucchetta P, Dall'Amico R, Gobber D, Calderan A, Maschio F, Pavanello L, Molinari PP, Scorrano D, Zanchetta S, Cassar W, Brisotto P, Corsini A, Sartori S, Da Dalt L, Murer L, Zacchello G. Antibiotic treatment for pyelonephritis in children: multicentre randomised controlled non-inferiority trial. BMJ. 2007 Aug 25;335(7616):386. doi: 10.1136/bmj.39244.692442.55. Epub 2007 Jul 4."}, {'pmid': '12535494', 'type': 'BACKGROUND', 'citation': 'Michael M, Hodson EM, Craig JC, Martin S, Moyer VA. Short versus standard duration oral antibiotic therapy for acute urinary tract infection in children. Cochrane Database Syst Rev. 2003;(1):CD003966. doi: 10.1002/14651858.CD003966.'}, {'pmid': '22122295', 'type': 'BACKGROUND', 'citation': 'Ammenti A, Cataldi L, Chimenz R, Fanos V, La Manna A, Marra G, Materassi M, Pecile P, Pennesi M, Pisanello L, Sica F, Toffolo A, Montini G; Italian Society of Pediatric Nephrology. Febrile urinary tract infections in young children: recommendations for the diagnosis, treatment and follow-up. Acta Paediatr. 2012 May;101(5):451-7. doi: 10.1111/j.1651-2227.2011.02549.x. Epub 2012 Jan 3.'}, {'pmid': '29500209', 'type': 'DERIVED', 'citation': 'Daniel M, Szajewska H, Panczyk-Tomaszewska M. 7-day compared with 10-day antibiotic treatment for febrile urinary tract infections in children: protocol of a randomised controlled trial. BMJ Open. 2018 Mar 2;8(3):e019479. doi: 10.1136/bmjopen-2017-019479.'}], 'seeAlsoLinks': [{'url': 'https://www.nice.org.uk/guidance/qs36', 'label': 'National Institute for Health and Care Excellence. Urinary tract infections in children and young people 2013 July'}, {'url': 'http://uroweb.org/guideline/paediatric-urology/#3', 'label': 'European Association of Urology; European Society for Pediatric Urology Urinary tract infections in children: EAU/ESPU guidelines.'}, {'url': 'http://www.cps.ca/en/documents/position/urinary-tract-infections-in-children', 'label': 'Canadian Paediatric Society, Urinary tract infection in infants and children: Diagnosis and management'}]}, 'descriptionModule': {'briefSummary': 'The investigators aim to assess the effectiveness of a 7-day compared with a 10-day course of antibiotic treatment for febrile urinary tract infections (UTIs) in children. It is formulated a hypothesis that a 7-day course of antibiotic therapy is equally effective as a 10-day course of therapy and would entail a lower risk of adverse events and better compliance.', 'detailedDescription': 'In previously published European and global guidelines, there has been no consensus among experts regarding the duration of therapy for a febrile UTI. Depending on the recommendation, the duration of treatment should be between 7-14 days.\n\n221 patients aged 3 months to 7 years with febrile UTIs (defined as a combination of fever and leukocyturia in urine sediment) will be randomly assigned to receive a 7-day treatment arm (7 days of cefuroxime/cefuroxime axetil followed by 3 days of blinded placebo) or a 10-day treatment arm (7 days of cefuroxime/cefuroxime axetil followed by 3 days of blinded cefuroxime axetil).\n\nThe primary outcome measure will be frequencies of recurrence and reinfection of UTI during the 6 months after the intervention. The secondary outcome measures will be antibiotic-associated diarrhea and compliance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (must have all):\n\n* children aged from 3 months to 7 years\n* clinical diagnosis of a febrile UTI at presentation according to urinalysis (white blood cells in the sediment \\>10 in the field of view);\n* fever ≥38°C\n* positive urine collection with sensitivity for cefuroxime\n* treatment cefuroxime or cefuroxime axetil for 7 days\n\nExclusion Criteria (must have one):\n\n* history of a UTI in the last 3 months\n* prophylaxis for UTI\n* antibiotic therapy in the last month\n* known allergy to the study drugs\n* immunosuppression therapy\n* disease with immune deficiency\n* children with other coexisting infection, e.g. meningitis, sepsis, pneumonia, otitis\n* severe obstructive uropathy'}, 'identificationModule': {'nctId': 'NCT03221504', 'briefTitle': '7-day Compared With 10-day Antibiotic Treatment for Febrile Urinary Tract Infections in Children', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'officialTitle': '7-day Compared With 10-day Antibiotic Treatment for Febrile Urinary Tract Infections in Children: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'WUM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Antibiotic therapy for 10 days', 'description': 'After 7 days of cefuroxime treatment (oral, intravenous or sequential), patients from day 8 to day 10 will continue to receive the antibiotic (in blinded bottle).', 'interventionNames': ['Other: Longer therapy duration']}, {'type': 'EXPERIMENTAL', 'label': 'Antibiotic therapy for 7 days', 'description': 'After 7 days of cefuroxime therapy (oral, intravenous or sequential), children from day 8 to day 10 will receive placebo (in blinded bottle).', 'interventionNames': ['Other: Shorter therapy duration']}], 'interventions': [{'name': 'Longer therapy duration', 'type': 'OTHER', 'description': 'Patients will receive cefuroxime axetil orally. Treatment will involve the supply of cefuroxime axetil 30 mg/kg/d in two divided doses (in blinded bottles).', 'armGroupLabels': ['Antibiotic therapy for 10 days']}, {'name': 'Shorter therapy duration', 'type': 'OTHER', 'description': 'Patients will receive placebo orally (in blinded bottles). The volume of the placebo will be like cefuroxime syrup.', 'armGroupLabels': ['Antibiotic therapy for 7 days']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02-091', 'city': 'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Maria Daniel, MD', 'role': 'CONTACT', 'email': 'maria.daniel@wum.edu.pl', 'phone': '696477117', 'phoneExt': '0048'}], 'facility': "Children's Hospital for The Medical University of Warsaw", 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '02-544', 'city': 'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Maria Daniel, MD', 'role': 'CONTACT'}], 'facility': 'The Holy Family Specialistic Hospital', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Maria Daniel, MD', 'role': 'CONTACT', 'email': 'maria.daniel@wum.edu.pl', 'phone': '+48696477117'}], 'overallOfficials': [{'name': 'Malgorzata Pańczyk-Tomaszewska, Assistant Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical Univeristy of Warsaw'}, {'name': 'Maria Daniel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Univeristy of Warsaw'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}