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
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.
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibiotic therapy for 10 days | Active Comparator | 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). |
|
| Antibiotic therapy for 7 days | Experimental | After 7 days of cefuroxime therapy (oral, intravenous or sequential), children from day 8 to day 10 will receive placebo (in blinded bottle). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Longer therapy duration | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| frequencies of recurrence of UTI | 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. | 3 months after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| frequencies of reinfection of UTI | The reinfection of a UTI is diagnosed when the next infection is caused by a different bacteria. | 6 months after intervention |
| antibiotic-associated diarrhoea (AAD), compliance |
Not provided
Inclusion Criteria (must have all):
Exclusion Criteria (must have one):
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Daniel, MD | Contact | +48696477117 | maria.daniel@wum.edu.pl |
| Name | Affiliation | Role |
|---|---|---|
| Malgorzata Pańczyk-Tomaszewska, Assistant Professor | Medical Univeristy of Warsaw | Study Chair |
| Maria Daniel, MD | Medical Univeristy of Warsaw | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital for The Medical University of Warsaw | Recruiting | Warsaw | 02-091 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26361319 | Background | 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. | |
| 17622599 | Background | 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. |
| Label | URL |
|---|---|
| National Institute for Health and Care Excellence. Urinary tract infections in children and young people 2013 July | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D011704 | Pyelonephritis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Shorter therapy duration | Other | Patients will receive placebo orally (in blinded bottles). The volume of the placebo will be like cefuroxime syrup. |
|
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.
Compliance 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.
| 7 days after intervention |
| The Holy Family Specialistic Hospital | Recruiting | Warsaw | 02-544 | Poland |
|
| 19864673 | Background | 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. |
| 21873693 | Background | 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. |
| 17611232 | Background | 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. |
| 12535494 | Background | 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. |
| 22122295 | Background | 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. |
| 29500209 | Derived | 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. |
| European Association of Urology; European Society for Pediatric Urology Urinary tract infections in children: EAU/ESPU guidelines. | View source |
| Canadian Paediatric Society, Urinary tract infection in infants and children: Diagnosis and management | View source |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D009395 | Nephritis, Interstitial |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D011702 | Pyelitis |