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Sponsors and Collaborators: |
University of Padova Regione Veneto IL Sogno di Stefano |
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Information provided by: | University of Padova |
ClinicalTrials.gov Identifier: | NCT00161330 |
The main objectives of the study are
Condition | Intervention | Phase |
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Urinary Tract Infections |
Drug: oral amoxicilline/clavulanic acid Drug: iv ceftriaxone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter Randomized Controlled Trial of Antibiotic Treatment in Children With Urinary Tract Infections: Oral Amoxicillin/Clavulanic Acid Vs Initial Iv Ceftriaxone. |
Estimated Enrollment: | 440 |
Study Start Date: | June 2000 |
Estimated Study Completion Date: | July 2005 |
Ages Eligible for Study: | 2 Months to 6 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study ID Numbers: | IRIS 1 |
Study First Received: | September 8, 2005 |
Last Updated: | September 8, 2005 |
ClinicalTrials.gov Identifier: | NCT00161330 |
Health Authority: | Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
urinary tract infection, antibiotic treatment childhood amoxicilline/clavulanic acid |
ceftriaxone renal ultrasonography renal scintigraphy |
Amoxicillin Urologic Diseases Clavulanic Acid |
Urinary Tract Infections Clavulanic Acids Ceftriaxone |
Anti-Infective Agents Anti-Bacterial Agents Communicable Diseases Molecular Mechanisms of Pharmacological Action |
Therapeutic Uses Enzyme Inhibitors Infection Pharmacologic Actions |