NCT03221504

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
221

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 18, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

March 20, 2018

Status Verified

July 1, 2017

Enrollment Period

1.6 years

First QC Date

July 7, 2017

Last Update Submit

March 19, 2018

Conditions

Urinary Tract Infections in Children

Keywords

urinary tract infectionspyelonephritiscefuroximechildren

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • frequencies of reinfection of UTI

    6 months after intervention

  • antibiotic-associated diarrhoea (AAD), compliance

    7 days after intervention

Study Arms (2)

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).

Other: Longer therapy duration

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).

Other: Shorter therapy duration

Interventions

Longer therapy durationOTHER

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 10 days
Shorter therapy durationOTHER

Patients will receive placebo orally (in blinded bottles). The volume of the placebo will be like cefuroxime syrup.

Antibiotic therapy for 7 days

Eligibility Criteria

Age3 Months - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Hospital for The Medical University of Warsaw

Warsaw, 02-091, Poland

RECRUITING

The Holy Family Specialistic Hospital

Warsaw, 02-544, Poland

RECRUITING

Related Publications (8)

  • 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: 26361319BACKGROUND

  • 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: 17622599BACKGROUND

  • 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: 19864673BACKGROUND

  • 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: 21873693BACKGROUND

  • 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: 17611232BACKGROUND

  • 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: 12535494BACKGROUND

  • 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: 22122295BACKGROUND

  • 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.

    PMID: 29500209DERIVED

Related Links

MeSH Terms

Conditions

Urinary Tract InfectionsPyelonephritis

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesNephritis, InterstitialNephritisKidney DiseasesPyelitis

Study Officials

  • Malgorzata Pańczyk-Tomaszewska, Assistant Professor

    Medical Univeristy of Warsaw

    STUDY CHAIR

  • Maria Daniel, MD

    Medical Univeristy of Warsaw

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Daniel, MD

CONTACT

+48696477117maria.daniel@wum.edu.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2017

First Posted

July 18, 2017

Study Start

January 1, 2018

Primary Completion

July 31, 2019

Study Completion

January 31, 2020

Last Updated

March 20, 2018

Record last verified: 2017-07

Locations

PL(2)