Aims:

In a double-blinded randomised controlled trial (RCT) is designed to answer the following research question: Does a longer course (12-13 days) of antibiotics compared to shorter course (5-6), improve short and medium-term clinical outcomes of children hospitalised with severe community-acquired pneumonia.

Objectives:

Primary objectives:
Our primary hypotheses are that in children hospitalised for pneumonia, 10-days of oral amoxicillin-clavulanic acid (compared with 3-days) after 48-72hrs of IV penicillin/ ampicillin/ceftriaxone will have superior:

  • Clinical cure rates (resolution of symptoms) at 3-4-weeks and
  • Medium-term clinical outcomes (fewer respiratory symptoms/signs and hospitalisation for respiratory illness) at 12-months.

Secondary objectives:
Our secondary objectives are to:

  • Determine the effect of the length of antibiotic treatment upon time to next hospitalisation for respiratory illness, chest x-ray (CXR) abnormalities at 3-4-weeks and 12-months later, treatment-related adverse effects and antibiotic resistance in respiratory bacterial pathogens.
  • Determine if demographic and clinical features, blood inflammatory indices and microbiological results at presentation predict short or medium-term outcomes following pneumonia.
  • Describe the prevalence of respiratory viruses and respiratory bacterial pathogens, including Mycoplasma pneumoniae, in the nasopharynx and beta-lactam antibiotic resistance in Streptococcus pneumoniae and Haemophilus influenzae, at presentation and 3-4-weeks later. 
Summary:

Studies in the Northern Territory (NT) have shown that recurrent pneumonia and other lung infections can lead to chronic lung disease (bronchiectasis). In the NT, respiratory infections are the most common reason for hospitalisation of young children. This pilot study seeks to identify if a longer course of oral antibiotics compared to a standard short course will improve short and medium term clinical outcomes for children hospitalised with severe community-acquired pneumonia.  It is hypothesised that a longer course of oral antibiotics will improve the clinical cure rates at 3-4 weeks and 12 months; reducing long-term respiratory morbidity.

Implications for policy and practice:

In this group of patients we intend to study to determine if a longer course of antibiotics for uncomplicated community-acquired pneumonia results in better short and medium-term clinical outcomes than the shorter, recommended 5-7 days course of treatment. Any observed clinical benefit will need to be measured against the impact of longer treatment courses upon overall antibiotic resistance in common respiratory bacterial pathogens.

Our research has found:

Recruitment ongoing

Chief investigator:
Project manager:
Contact information:
Project dates:

2014 - 2016