Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001725459
Ethics application status
Approved
Date submitted
29/11/2016
Date registered
16/12/2016
Date last updated
24/04/2020
Date data sharing statement initially provided
27/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial on duration of amoxycillin clavulanic acid for chronic wet cough in children
Scientific title
Randomised controlled trial on duration of amoxycillin clavulanic acid for chronic wet cough in children
Secondary ID [1] 290648 0
Nil
Universal Trial Number (UTN)
U1111-1190-4854
Trial acronym
DACs
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Paediatric cough 301176 0
Chronic wet or productive cough 301177 0
Condition category
Condition code
Respiratory 300933 300933 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
28 days of amoxycillin clavulanic acid
Dose 25-30 mg/kg/dose in oral liquid given twice per day
Adherence monitored by return of bottles
Intervention code [1] 296533 0
Treatment: Drugs
Comparator / control treatment
14 days of amoxycillin clavulanic acid (25-30 mg/kg/dose twice per day) followed by 14 days of liquid placebo at the same volume in mLs as the first 14 days.
The placebo will be made by a pharmaceutical company to taste and look the same as amoxycillin clavulanic acid but with no active medication.
Control group
Placebo

Outcomes
Primary outcome [1] 300354 0
Proportion of children who are cured (defined assessed as no cough or reduction in cough score for >75% (compared to start of study drug) for for 3 days using a validated paediatric cough diary [1])

[1] Chang AB, et al. Subjective scoring of cough in children: parent-completed vs child-completed diary cards vs an objective method. Eur Respir J 1998;11:462-6.
Timepoint [1] 300354 0
Day 28
Primary outcome [2] 300362 0
Quality of life as measured by parent proxy cough specific quality of life score (PC-QoL)
Timepoint [2] 300362 0
Day 28
Primary outcome [3] 300363 0
Recurrence of episodes of wet cough requiring treatment with antibiotics based on parent reports/diary
Timepoint [3] 300363 0
6 months post medications
Secondary outcome [1] 329768 0
Antimicrobial resistance of common respiratory bacteria present in deep nasal swabs
Timepoint [1] 329768 0
Day 28
Secondary outcome [2] 329769 0
Adverse events such as vomiting and diarrhoea as reported by parents
Timepoint [2] 329769 0
Day 28

Eligibility
Key inclusion criteria
1. Chronic (>4 weeks) wet or productive cough
2. Aged 2 months to 19 years
3. Requires antibiotics for their cough as determined by the regular treating physician
Minimum age
2 Months
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known hypersensitivity to penicillin
Recent use of antibiotics (i.e. within the preceding 3 weeks)
Children with a diagnosed respiratory condition such as cystic fibrosis, bronchiectasis, etc.
Children requiring hospitalisation
Immunodeficiency (primary or secondary)
Chest xray abnormality e.g. pneumonia (other than peribronchial thickening)

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)
A study statistician not directly involved in the analysis of study results, located off site, will prepare the study randomisation code in a statistical database. A stratified (stratification by site; and age) randomisation blocking scheme with varying block sizes will be used to ensure that balance between the two treatment groups are maintained.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Superiority RCT
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The main effect of the intervention will be determined by comparing the primary outcome i.e. proportion clinically cured (resolution of cough) at 28-days. Intention to treat analysis will be used, For the primary outcome and other categorical data (bacteria AB resistance, adverse events), the difference between groups will be compared using chi2, Student’s T test used for continuous data comparisons (assuming normal distribution based on our previous studies) i.e. change in PC-QoL scores.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2017
Actual
1/03/2017
Date of last participant enrolment
Anticipated
31/12/2019
Actual
11/09/2019
Date of last data collection
Anticipated
30/06/2020
Actual
1/04/2020
Sample size
Target
100
Accrual to date
Final
111
Recruitment in Australia
Recruitment state(s)
NT,QLD,WA
Recruitment hospital [1] 7008 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment hospital [2] 7009 0
Royal Darwin Hospital - Tiwi
Recruitment hospital [3] 7010 0
The Wesley Hospital - Auchenflower
Recruitment hospital [4] 12051 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 14740 0
4101 - South Brisbane
Recruitment postcode(s) [2] 14741 0
0810 - Tiwi
Recruitment postcode(s) [3] 14742 0
4066 - Auchenflower
Recruitment postcode(s) [4] 24208 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 295082 0
University
Name [1] 295082 0
Queensland University of Technology
Country [1] 295082 0
Australia
Funding source category [2] 295186 0
Charities/Societies/Foundations
Name [2] 295186 0
Children's Hospital Foundation
Country [2] 295186 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
IHBI
60 Musk Ave
Kelvin Grove Qld 4059
Country
Australia
Secondary sponsor category [1] 293909 0
Hospital
Name [1] 293909 0
Children's Health Queensland
Address [1] 293909 0
Lady Cilento Children's Hospital
Stanley St
South Brisbane Qld 4101
Country [1] 293909 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296436 0
Children's Health Queensland Hospital and Health Services
Ethics committee address [1] 296436 0
Ethics committee country [1] 296436 0
Australia
Date submitted for ethics approval [1] 296436 0
28/11/2016
Approval date [1] 296436 0
13/12/2016
Ethics approval number [1] 296436 0
HREC/16/QRCH/387

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

Contacts
Principal investigator
Name 70838 0
Prof Anne Chang
Address 70838 0
Cough, Asthma, Airways Research Group (CAARG), Level 7
Centre for Children's Health Research
62 Graham St
South Brisbane Qld 4101
Country 70838 0
Australia
Phone 70838 0
+61 7 30697283
Fax 70838 0
Email 70838 0
[email protected]
Contact person for public queries
Name 70839 0
Anne Chang
Address 70839 0
CAARG, Level 7
Centre for Children's Health Research
62 Graham St
South Brisbane Qld 4101
Country 70839 0
Australia
Phone 70839 0
+61 7 30697283
Fax 70839 0
Email 70839 0
[email protected]
Contact person for scientific queries
Name 70840 0
Anne Chang
Address 70840 0
CAARG, Level 7
Centre for Children's Health Research
62 Graham St
South Brisbane Qld 4101
Country 70840 0
Australia
Phone 70840 0
+ 61 7 30697283
Fax 70840 0
Email 70840 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
EmbaseDuration of amoxicillin-clavulanate for protracted bacterial bronchitis in children (DACS): a multi-centre, double blind, randomised controlled trial.2021https://dx.doi.org/10.1016/S2213-2600%2821%2900104-1
N.B. These documents automatically identified may not have been verified by the study sponsor.