Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000533695
Ethics application status
Approved
Date submitted
11/09/2005
Date registered
28/09/2005
Date last updated
12/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomized controlled trial of antibiotics in children with chronic moist cough
Scientific title
A randomized double-blinded placebo-controlled trial of amoxycillin/clavulanic acid in children with chronic moist cough to improve cough scores.
Secondary ID [1] 280460 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic (>3 weeks) moist cough in children 658 0
Condition category
Condition code
Respiratory 731 731 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention is 14 days of oral amoxycillin/clavulanate 400mg/5ml suspension.
Intervention code [1] 454 0
Treatment: Drugs
Comparator / control treatment
Placebo suspension at dose of 22.5mg/kg twice daily.
Control group
Placebo

Outcomes
Primary outcome [1] 902 0
Success of treatment through the use of verbal category descriptive scores of cough, a previously validated tool.
Timepoint [1] 902 0
Immediately pre-treatment and at the conclusion of treatment.
Secondary outcome [1] 1759 0
Bronchoalveolar lavage results will be available from day 1 in a percentage of patients and secondary outcomes will include the analysis of microbiology, cytology and inflammatory markers as evidence of a bacterial infection in responders and non-responders (all at day 1).
Timepoint [1] 1759 0
Day 1 on enrolment

Eligibility
Key inclusion criteria
Children with chronic (>3 week duration) moist cough.
Minimum age
6 Months
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clinical or HRCT-proven bronchiectasis, gross neurodevelopmental delay, cystic fibrosis, known chronic disease such as interstitial lung disease or cardiac disease. Also children who have had antibiotic therapy in the preceding 2 weeks or who are allergic to penicillin will be excluded.

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)
To ensure adequate concealment a black sticker obscures the next treatment group on the original treatment allocation sheet and a photocopy of this is used by the investigators. The original sheet with black stickers is held in the pharmacy department where the dipsensing of the mediciation is done without knowledge of investigators or patients.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
After written consent is obtained the children will be randomized, stratified by age ( < 6 years and >= 6 years of age). They will subsequently be allocated to the next patient number on a list, which has been previously generated, in random order, by drawing a letter (a,b) from a container, at a remote site by a non-investigator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2004
Actual
5/01/2004
Date of last participant enrolment
Anticipated
1/12/2006
Actual
12/12/2006
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 812 0
Charities/Societies/Foundations
Name [1] 812 0
TSANZ/Allen and Hanbury's Paediatric Respiratory Medicine Career Development Fellowship
Country [1] 812 0
Australia
Funding source category [2] 813 0
Charities/Societies/Foundations
Name [2] 813 0
Royal Children's Hospital Working Wonders Foundation
Country [2] 813 0
Australia
Primary sponsor type
Hospital
Name
Department of Respiratory Medicine, Royal Children's Hospital
Address
Royal Children's Hospital, Herston Road, Herston, Qld, 4029
Country
Australia
Secondary sponsor category [1] 680 0
Individual
Name [1] 680 0
Julie Marchant
Address [1] 680 0
Royal Children's Hospital, Respiratory Dept,
Level 5, Herston Road, Herston, Qld, 4029
Country [1] 680 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2080 0
Royal Children's Hospital Ethics Committee
Ethics committee address [1] 2080 0
Ethics committee country [1] 2080 0
Australia
Date submitted for ethics approval [1] 2080 0
Approval date [1] 2080 0
01/11/2003
Ethics approval number [1] 2080 0

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

Contacts
Principal investigator
Name 35385 0
Dr Dr Julie Marchant
Address 35385 0
Dr Julie Marchant
Level 7
Centre for Children's Health Research
64 Raymond Terrace
South Brisbane Qld 4101
Country 35385 0
Australia
Phone 35385 0
+61730697350
Fax 35385 0
Email 35385 0
[email protected]
Contact person for public queries
Name 9643 0
Dr Julie Marchant
Address 9643 0
Department of Respiratory Medicine
Royal Children's Hospital
Level 3
Woolworths Building
Herston Road
Herston QLD 4029
Country 9643 0
Australia
Phone 9643 0
+61 7 36368523
Fax 9643 0
+61 7 36361958
Email 9643 0
[email protected]
Contact person for scientific queries
Name 571 0
Dr Julie Marchant
Address 571 0
Department of Respiratory Medicine
Royal Children's Hospital
Level 3
Woolworths Building
Herston Road
Herston QLD 4029
Country 571 0
Australia
Phone 571 0
+61 7 36368523
Fax 571 0
+61 7 36361958
Email 571 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
SourceTitleYear of PublicationDOI
EmbaseRandomised controlled trial of amoxycillin clavulanate in children with chronic wet cough.2012https://dx.doi.org/10.1136/thoraxjnl-2011-201506
N.B. These documents automatically identified may not have been verified by the study sponsor.