Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000456358
Ethics application status
Approved
Date submitted
29/08/2008
Date registered
15/09/2008
Date last updated
15/09/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
A double blind randomised placebo controlled study using clarithromycin in the treatment of children with bronchiolitis
Scientific title
A double blind randomised placebo controlled study using clarithromycin in the treatment of children with bronchiolitis
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
bronchiolitis 3621 0
Condition category
Condition code
Respiratory 3782 3782 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
clarithroymycin in the treatment of bronchiolitis. oral dose of 15 mg/kg/day for a maximum of 6 doses or until hospital discharge
Intervention code [1] 3332 0
Treatment: Drugs
Comparator / control treatment
placebo will be a sugar pill. oral dose up to a maximum of 6 doses or until hospital discharge
Control group
Placebo

Outcomes
Primary outcome [1] 4674 0
treatment of bronchiolitis in children. tools will include vital signs, naso-pharyngeal aspirate, amount of supplemental oxygen required, auscultation of chest, level of hydration
Timepoint [1] 4674 0
length of hospital stay. assessed daily
Secondary outcome [1] 7895 0
recurrence of bronchiolitis after hospital discharge. Phone call follow up or re-presentation to hospital
Timepoint [1] 7895 0
monthly phone call follow up or re-presentation to hospital until 4 months after discharge
Secondary outcome [2] 7956 0
recurrence of bronchioloitis after hospital discharge
Timepoint [2] 7956 0
up until 4 months after discharge

Eligibility
Key inclusion criteria
children aged 1-12 months hospitalised with bronchiolitis
Minimum age
4 Weeks
Maximum age
12 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
cardiac disease, cystic fibrosis, chronic lung disease, Intensive care unit admission, steroid therapy, bronchodilators within 4 hours of presentation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
104
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3797 0
Hospital
Name [1] 3797 0
royal childrens hospital
Country [1] 3797 0
Australia
Primary sponsor type
Hospital
Name
royal children's hospital
Address
flemington rd parkville, VIC, 3052
Country
Australia
Secondary sponsor category [1] 3407 0
None
Name [1] 3407 0
Address [1] 3407 0
Country [1] 3407 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5855 0
Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 5855 0
Ethics committee country [1] 5855 0
Australia
Date submitted for ethics approval [1] 5855 0
Approval date [1] 5855 0
17/07/2008
Ethics approval number [1] 5855 0
28023

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28883 0
Address 28883 0
Country 28883 0
Phone 28883 0
Fax 28883 0
Email 28883 0
Contact person for public queries
Name 12040 0
noel cranswick
Address 12040 0
Clinical Pharmacology, APPRU. Royal Childrens Hospital, flemington rd, parkville, VIC, 3052
Country 12040 0
Australia
Phone 12040 0
+61 3 9345 6987
Fax 12040 0
Email 12040 0
[email protected]
Contact person for scientific queries
Name 2968 0
noel cranswick
Address 2968 0
Clinical Pharmacology, APPRU. Royal Childrens Hospital, flemington rd, parkville, VIC, 3052
Country 2968 0
Australia
Phone 2968 0
+61 3 9345 6987
Fax 2968 0
Email 2968 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.