7-day Compared With 10-day Antibiotic Treatment for Febrile Urinary Tract Infections in Children

Urinary Tract Infections in Children Clinical Trial

Official title:

7-day Compared With 10-day Antibiotic Treatment for Febrile Urinary Tract Infections in Children: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03221504
• Other study ID #: WUM
• Status: Recruiting
• Phase: N/A
• First received: July 7, 2017
• Last updated: March 19, 2018
• Start date: January 1, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: July 2017
• Source: Medical University of Warsaw
• Contact: Maria Daniel, MD
• Phone: +48696477117
• Email: maria.daniel[@]wum.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 221
• Est. completion date: January 31, 2020
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 7 Years

Eligibility

Inclusion Criteria (must have all):

• children aged from 3 months to 7 years

• 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 (must have one):

• history of a UTI in the last 3 months

• 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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Urinary Tract Infections
• Urinary Tract Infections in Children

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Poland	Children's Hospital for The Medical University of Warsaw	Warsaw
Poland	The Holy Family Specialistic Hospital	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

References & Publications (7)

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. — View 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. — View 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. Erratum in: N Engl J Med. 2010 Apr 1;362(13):1250. — View 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. Review. — View 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. Epub 2007 Jul 4. — View Citation

Simões 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	antibiotic-associated diarrhoea (AAD), compliance	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

External Links

•   American Academy of Pediatrics: Clinical Practice Guideline for the Diagnosis and Management of the Initial UTI in Febrile Infants and Children 2 to 24 Months
•   Canadian Paediatric Society, Urinary tract infection in infants and children: Diagnosis and management
•   Diagnosis and Treatment of Urinary Tract Infection in Children KHA-CARI Guideline
•   European Association of Urology; European Society for Pediatric Urology Urinary tract infections in children: EAU/ESPU guidelines.
•   National Institute for Health and Care Excellence. Urinary tract infections in children and young people 2013 July
•   Polish Society of Pediatric Nephrology, Guidelines in UTI