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

This study has been terminated.

First Received on September 8, 2005. No Changes Posted

Sponsor:	University of Padova
Collaborators:	Regione Veneto IL Sogno di Stefano
Information provided by:	University of Padova
ClinicalTrials.gov Identifier:	NCT00161330

Purpose

The main objectives of the study are

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

Condition	Intervention	Phase
Urinary Tract Infections	Drug: oral amoxicilline/clavulanic acid Drug: iv ceftriaxone	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Multicenter Randomized Controlled Trial of Antibiotic Treatment in Children With Urinary Tract Infections: Oral Amoxicillin/Clavulanic Acid Vs Initial Iv Ceftriaxone.

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Nuclear Scans Ultrasound Urinary Tract Infections Urine and Urination

Drug Information available for: Amoxicillin sodium Amoxicillin Ceftriaxone Ceftriaxone sodium

U.S. FDA Resources

Further study details as provided by University of Padova:

Primary Outcome Measures:

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.

Estimated Enrollment:	440
Study Start Date:	June 2000
Estimated Study Completion Date:	July 2005

Show Detailed Description

Eligibility

Ages Eligible for Study:	2 Months to 6 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00161330

Sponsors and Collaborators

University of Padova

Regione Veneto

IL Sogno di Stefano

Investigators

Study Chair:	Graziella Zacchello, Professor	Nephrology, dialysis and transplant unit, Pediatric Departement, Azienda ospdealiera-università, Padova
Principal Investigator:	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

More Information

Publications:

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.

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.

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.

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.

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.

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

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.

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

ClinicalTrials.gov Identifier:	NCT00161330 History of Changes
Other Study ID Numbers:	IRIS 1
Study First Received:	September 8, 2005
Last Updated:	September 8, 2005
Health Authority:	Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by University of Padova:

urinary tract infection,
antibiotic treatment
childhood
amoxicilline/clavulanic acid

ceftriaxone
renal ultrasonography
renal scintigraphy

Additional relevant MeSH terms:

Urinary Tract Infections
Infection
Urologic Diseases
Amoxicillin
Anti-Bacterial Agents
Ceftriaxone
Clavulanic Acids

Clavulanic Acid
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 24, 2012