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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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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12608000456358 |
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Date of registration:
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15/09/2008 |
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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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A double blind randomised placebo controlled study using clarithromycin in the treatment of children with bronchiolitis
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Scientific title:
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A double blind randomised placebo controlled study using clarithromycin in the treatment of children with bronchiolitis |
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Date of first enrolment:
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01/01/2009 |
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Target sample size:
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104 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://anzctr.org.au/ACTRN12608000456358.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial;
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Phase:
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Countries of recruitment
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Australia
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Contacts
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Name:
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noel cranswick
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Address:
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Clinical Pharmacology, APPRU. Royal Childrens Hospital, flemington rd, parkville, VIC, 3052
Australia |
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Telephone:
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+61 3 9345 6987 |
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Email:
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noel.cranswick@rch.org.au |
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Affiliation:
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Name:
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noel cranswick
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Address:
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Clinical Pharmacology, APPRU. Royal Childrens Hospital, flemington rd, parkville, VIC, 3052
Australia |
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Telephone:
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+61 3 9345 6987 |
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Email:
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noel.cranswick@rch.org.au |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: children aged 1-12 months hospitalised with bronchiolitis
Exclusion criteria: cardiac disease, cystic fibrosis, chronic lung disease, Intensive care unit admission, steroid therapy, bronchodilators within 4 hours of presentation
Age minimum:
4 Weeks
Age maximum:
12 Months
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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bronchiolitis;
bronchiolitis
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Respiratory - Other respiratory disorders / diseases
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Intervention(s)
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clarithroymycin in the treatment of bronchiolitis. oral dose of 15 mg/kg/day for a maximum of 6 doses or until hospital discharge
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Primary Outcome(s)
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treatment of bronchiolitis in children. tools will include vital signs, naso-pharyngeal aspirate, amount of supplemental oxygen required, auscultation of chest, level of hydration[length of hospital stay. assessed daily]
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Secondary Outcome(s)
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recurrence of bronchiolitis after hospital discharge. Phone call follow up or re-presentation to hospital[monthly phone call follow up or re-presentation to hospital until 4 months after discharge]
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recurrence of bronchioloitis after hospital discharge[up until 4 months after discharge]
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Source(s) of Monetary Support
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royal childrens hospital
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Ethics review
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Status: Approved
Approval date:
Contact:
Royal Children's Hospital Human Research Ethics Committee
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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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