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

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ClinicalTrials.gov Identifier: NCT00161330
Recruitment Status : Terminated
First Posted : September 12, 2005
Last Update Posted : December 14, 2020
Regione Veneto
IL Sogno di Stefano
Information provided by:
University of Padova

Brief Summary:

The main objectives of the study are

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

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : June 2000
Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 1. Duration of fever (>38°),
  2. 2. Sterilization of the urine,
  3. 3. Reduction of the blood inflammatory indices,
  4. 4. Incidence of renal scarring documented at 12 month.

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00161330

Sponsors and Collaborators
University of Padova
Regione Veneto
IL Sogno di Stefano
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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00161330    
Other Study ID Numbers: IRIS 1
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: December 14, 2020
Last Verified: July 2004
Keywords provided by University of Padova:
urinary tract infection,
antibiotic treatment
amoxicilline/clavulanic acid
renal ultrasonography
renal scintigraphy
Additional relevant MeSH terms:
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Communicable Diseases
Urinary Tract Infections
Disease Attributes
Pathologic Processes
Urologic Diseases
Clavulanic Acids
Clavulanic Acid
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
beta-Lactamase Inhibitors