Prophylactic antibiotics to prevent chest infections in children with neurological impairment (PARROT) trial

 

Funder:
  • National Health and Medical Research Council (NHMRC)
Collaborators:
  • Menzies School of Health Research
  • Brisbane Children’s Hospital
  • Murdoch Children’s Research Institute
  • Queensland University of Technology
  • Royal Children’s Hospital, Melbourne
  • University of Melbourne
  • Liverpool University
  • + 40 sites in the United Kingdom

This is a joint UK and Australian multi-centre, randomised, double blind, placebo controlled pragmatic trial.

Aims:

Primary aim:

  • To determine whether 52 weeks of azithromycin prophylaxis is more effective than placebo in reducing the proportion of children with non-progressive neurological impairment admitted to hospital with lower respiratory tract infections (LRTI).

Secondary aims:

  • To determine if 52 weeks of antibiotic prophylaxis with azithromycin compared to placebo improves:

i) Parent-reported health-related Quality of Life for both parent and child/young person
ii) Child / young person nutritional status
iii) Amount and quality of sleep for both parent and child / young person
iv) Child / young person Liverpool Respiratory Symptom Questionnaire-Neuro score
v) The cost-effectiveness of prophylactic azithromycin based on resource use and costs associated with 52 weeks of antibiotic prophylaxis with azithromycin and the number of quality-adjusted life years experienced
vi) Respiratory tract microbiology and specifically rates of antimicrobial resistance
vii) The point prevalence of respiratory viral and bacterial detection for respiratory hospitalisations

Summary:

Children with neurological impairment are at high-risk of LRTI, often leading to recurrent hospitalisations. This places a huge burden on children, families and health care services.

To prevent LRTIs, some children are prescribed prophylactic antibiotics, but the type, duration and dose of antibiotics varies considerably. Azithromycin is one of several antibiotics used for these children. However, these medications are not without side-effects, with concerns about long-term use, and antimicrobial resistance.

A Cochrane review recently highlighted the lack of evidence supporting their use in this group of patients and recommended that further research in this area is needed. Azithromycin was chosen for this trial as it has been proven effective in the prevention and treatment of severe LRTI and reducing exacerbations/hospitalisations for children with bronchiectasis.

Implications for policy and practice:

Study results will inform clinical practice and national/international guidance for children with neurological impairment.

Chief investigator:
Project manager:
Contact information:

For further information about the study, email Fransisca Tenorio

Information for study participants or if you wish to get involved in this project can be found on our trial website. 

Project dates:

The project commenced in 2017 and is due to be completed in 2024.