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Randomised controlled trial on duration of amoxycillin clavulanic acid for chronic wet cough in children

Randomised controlled trial on duration of amoxycillin clavulanic acid for chronic wet cough in children

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001725459
Acronym
DACs
Enrollment
111
Registered
2016-12-16
Start date
2017-03-01
Completion date
2019-09-11
Last updated
2020-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Cough is a very common problem in childhood. Chronic wet or productive cough can be distressing and irritating, both for children living with it and their families. The journey through investigations, diagnoses and management can be diverse and costly. This project (also known as a clinical trial) aims to compare two weeks versus four weeks of an antibiotic (amoxycillin clavulanic acid) for the treatment of chronic wet cough in children. This antibiotic is widely used by respiratory doctors however there is little evidence to support the correct duration. This project aims to determine if two or four weeks of amoxycillin clavulanic acid (Augmentin Duo) cures the wet cough and helps to delay the time until the child becomes unwell again with wet cough. This project also aims to improve our understanding on the bacteria found in the airways of children with wet cough and antibiotic resistance. Children can be enrolled if they need antibiotics to treat their chronic wet cough (defined as >4 weeks of wet cough). All children enrolled will receive 2 weeks of amoxycillin clavulanic acid and then another 2 weeks of either placebo or amoxycillin clavulanic acid. The study duration will be for 7 months in total; 1 month on study medications and 6 months of follow up via phone.

Interventions

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

Sponsors

Queensland University of Technology
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
2 Months to 19 Years
Healthy volunteers
No

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

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)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 22, 2026