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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03221504 |
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Date of registration:
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07/07/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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7-day Compared With 10-day Antibiotic Treatment for Febrile Urinary Tract Infections in Children
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Scientific title:
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7-day Compared With 10-day Antibiotic Treatment for Febrile Urinary Tract Infections in Children: a Randomized Controlled Trial |
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Date of first enrolment:
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January 1, 2018 |
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Target sample size:
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221 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT03221504 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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N/A
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Countries of recruitment
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Poland
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Contacts
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Name:
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Maria Daniel, MD |
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Address:
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Telephone:
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+48696477117 |
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Email:
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maria.daniel@wum.edu.pl |
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Affiliation:
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Name:
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Maria Daniel, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical Univeristy of Warsaw |
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Name:
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Malgorzata Panczyk-Tomaszewska, Assistant Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical Univeristy of Warsaw |
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Key inclusion & exclusion criteria
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Inclusion Criteria (must have all):
- 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
Exclusion Criteria (must have one):
- 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
Age minimum:
3 Months
Age maximum:
7 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Urinary Tract Infections in Children
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Intervention(s)
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Other: Longer therapy duration
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Other: Shorter therapy duration
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Primary Outcome(s)
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frequencies of recurrence of UTI
[Time Frame: 3 months after intervention]
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Secondary Outcome(s)
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frequencies of reinfection of UTI
[Time Frame: 6 months after intervention]
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antibiotic-associated diarrhoea (AAD), compliance
[Time Frame: 7 days after intervention]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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