7-day Compared With 10-day Antibiotic Treatment for Febrile Urinary Tract Infections in Children
NCT ID: NCT03221504
Last Updated: 2018-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
221 participants
INTERVENTIONAL
2018-01-01
2020-01-31
Brief Summary
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Detailed Description
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221 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).
The 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Antibiotic therapy for 10 days
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).
Longer therapy duration
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).
Antibiotic therapy for 7 days
After 7 days of cefuroxime therapy (oral, intravenous or sequential), children from day 8 to day 10 will receive placebo (in blinded bottle).
Shorter therapy duration
Patients will receive placebo orally (in blinded bottles). The volume of the placebo will be like cefuroxime syrup.
Interventions
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Longer therapy duration
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).
Shorter therapy duration
Patients will receive placebo orally (in blinded bottles). The volume of the placebo will be like cefuroxime syrup.
Eligibility Criteria
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Inclusion Criteria
* clinical diagnosis of a febrile UTI at presentation according to urinalysis (white blood cells in the sediment \>10 in the field of view);
* fever ≥38°C
* positive urine collection with sensitivity for cefuroxime
* treatment cefuroxime or cefuroxime axetil for 7 days
Exclusion Criteria
* prophylaxis for UTI
* antibiotic therapy in the last month
* known allergy to the study drugs
* immunosuppression therapy
* disease with immune deficiency
* children with other coexisting infection, e.g. meningitis, sepsis, pneumonia, otitis
* severe obstructive uropathy
3 Months
7 Years
ALL
No
Sponsors
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Medical University of Warsaw
OTHER
Responsible Party
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Principal Investigators
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Malgorzata Pańczyk-Tomaszewska, Assistant Professor
Role: STUDY_CHAIR
Medical Univeristy of Warsaw
Maria Daniel, MD
Role: PRINCIPAL_INVESTIGATOR
Medical Univeristy of Warsaw
Locations
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Children's Hospital for The Medical University of Warsaw
Warsaw, , Poland
The Holy Family Specialistic Hospital
Warsaw, , Poland
Countries
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Central Contacts
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Facility Contacts
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Maria Daniel, MD
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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National Institute for Health and Care Excellence. Urinary tract infections in children and young people 2013 July
European Association of Urology; European Society for Pediatric Urology Urinary tract infections in children: EAU/ESPU guidelines.
Canadian Paediatric Society, Urinary tract infection in infants and children: Diagnosis and management
Other Identifiers
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WUM
Identifier Type: -
Identifier Source: org_study_id
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