Oral vs Initial Intravenous Antibiotic Treatment of Urinary Tract Infections in Children: a RCT

NCT00161330 | Terminated Phase 3

• 1 other identifier: IRIS 1
• Study Type: interventional
• Target: 440
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main objectives of the study are

1. 1.to compare the efficacy of oral vs initial iv antibiotic treatment in children with a first episode of UTI
2. 2.to assess the diagnostic power of the various imaging technique (renal ultrasonogram, voiding cystourethrogram, and renal scanning with technetium-99m-labeled dimercaptosuccinic acid)

Conditions

Urinary Tract Infections

Keywords

urinary tract infection,; antibiotic treatment; childhood; amoxicilline/clavulanic acid; ceftriaxone; renal ultrasonography; renal scintigraphy

Outcome Measures

Primary Outcomes (4)

• 1. Duration of fever (>38°),

• 2. Sterilization of the urine,

• 3. Reduction of the blood inflammatory indices,

• 4. Incidence of renal scarring documented at 12 month.

Interventions

oral amoxicilline/clavulanic acid DRUG

iv ceftriaxone DRUG

Eligibility Criteria

• Age: 2 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age between 2 months and 6 years,
• normal renal function
• first episode of upper UTI (fever, 2 consecutive positive urinalysis, later confirmed by 2 cultures and high blood inflammation indices)

You may not qualify if:

• documented previous urinary tract malformation (prenatal ultrasound)
• seriously compromised general conditions (such as sepsis or vomit)
• hypersensitivity to the antibiotics considered.

Sponsors & Collaborators

• University of Padova: lead
• Regione Veneto: collaborator
• IL Sogno di Stefano: collaborator

Related Publications (10)

• Ghiro L, Cracco AT, Sartor M, Comacchio S, Zacchello G, Dall'Amico R; Veneto Urinary Tract Infection Study Group. Retrospective study of children with acute pyelonephritis. Evaluation of bacterial etiology, antimicrobial susceptibility, drug management and imaging studies. Nephron. 2002 Jan;90(1):8-15. doi: 10.1159/000046308.

  PMID: 11744799 BACKGROUND

• Hoberman A, Wald ER, Hickey RW, Baskin M, Charron M, Majd M, Kearney DH, Reynolds EA, Ruley J, Janosky JE. Oral versus initial intravenous therapy for urinary tract infections in young febrile children. Pediatrics. 1999 Jul;104(1 Pt 1):79-86. doi: 10.1542/peds.104.1.79.

  PMID: 10390264 BACKGROUND

• Downs SM. Technical report: urinary tract infections in febrile infants and young children. The Urinary Tract Subcommittee of the American Academy of Pediatrics Committee on Quality Improvement. Pediatrics. 1999 Apr;103(4):e54. doi: 10.1542/peds.103.4.e54.

  PMID: 10103346 BACKGROUND

• Jakobsson B, Esbjorner E, Hansson S. Minimum incidence and diagnostic rate of first urinary tract infection. Pediatrics. 1999 Aug;104(2 Pt 1):222-6. doi: 10.1542/peds.104.2.222.

  PMID: 10428998 BACKGROUND

• Cornu C, Cochat P, Collet JP, Delair S, Haugh MC, Rolland C. Survey of the attitudes to management of acute pyelonephritis in children. GEP. Pediatr Nephrol. 1994 Jun;8(3):275-7. doi: 10.1007/BF00866331.

  PMID: 7917849 BACKGROUND

• Jodal U. Treatment trials on children with acute pyelonephritis. Pediatr Nephrol. 1994 Jun;8(3):278-9. doi: 10.1007/BF00866332. No abstract available.

  PMID: 7917850 BACKGROUND

• Hoberman A, Charron M, Hickey RW, Baskin M, Kearney DH, Wald ER. Imaging studies after a first febrile urinary tract infection in young children. N Engl J Med. 2003 Jan 16;348(3):195-202. doi: 10.1056/NEJMoa021698.

  PMID: 12529459 BACKGROUND

• Levtchenko EN, Ham HR, Levy J, Piepsz A. Attitude of Belgian pediatricians toward strategy in acute pyelonephritis. Pediatr Nephrol. 2001 Feb;16(2):113-5. doi: 10.1007/s004670000531.

  PMID: 11261676 BACKGROUND

• Hewitt IK, Zucchetta P, Rigon L, Maschio F, Molinari PP, Tomasi L, Toffolo A, Pavanello L, Crivellaro C, Bellato S, Montini G. Early treatment of acute pyelonephritis in children fails to reduce renal scarring: data from the Italian Renal Infection Study Trials. Pediatrics. 2008 Sep;122(3):486-90. doi: 10.1542/peds.2007-2894.

  PMID: 18762516 DERIVED

• 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: 17611232 DERIVED

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Amoxicillin; Clavulanic Acid; Ceftriaxone

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Clavulanic Acids; Cefotaxime; Cephacetrile; Cephalosporins; Thiazines

Study Officials

• Graziella Zacchello, Professor

  Nephrology, dialysis and transplant unit, Pediatric Departement, Azienda ospdealiera-università, Padova

  STUDY CHAIR

• Antonella Toffolo, Dr

  Pediatric Unit, Ospedale di Oderzo, Italy

  PRINCIPAL INVESTIGATOR

• Giovanni Montini, Dr

  Nephrology, Dialysis and Transplant Unit, Pediatric Departement, Azienda Ospedaliera - Università, Padova Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: June 1, 2000
• Study Completion: July 1, 2005
• Last Updated: December 14, 2020

Record last verified: 2004-07