Hospitalised Pneumonia With Extended Treatment (HOPE) Study

A multi-centre double-blind randomised controlled trial to determine if a longer duration of amoxicillin-clavulanic acid (compared to shorter duration) improves the short and long term clinical outcomes of children hospitalised with community-acquired pneumonia, in Indigenous children and a developing country

Inclusion criteria

• Hospitalised children aged 3-mo to 5-yrs (in Darwin, children have to be Indigenous)
• Have features of severe pneumonia on admission (temperature >37.5 celsius or a history of fever at home or observed at the referring clinic, age-adjusted tachypnoea [respiratory rate>50 if <12-months; respiratory rate>40 if >12-months] with chest wall recession and/or oxygen saturation <92% in air), and consolidation on chest X-ray as diagnosed by treating clinician
• After 1-3 days of IV antibiotics, are afebrile, with improved respiratory symptoms and signs, oxygen saturation>90% in air and are ready to be switched to oral amoxicillin-clavulanate, and
• Have symptoms of no longer than 7 days at point of hospitalisation.

Exclusion criteria

• Current wheeze
• Underlying chronic illness other than asthma (e.g. bronchiectasis, cyanotic congenital heart disease or cardiac failure, neuromuscular disorders, immunodeficiency) that could potentially influence the current illness
• Severe malnutrition (weight-for-height Z-score <-3)
• Complicated (effusion, empyema or abscess) pneumonia, including tuberculosis
• Extra-pulmonary infection requiring antibiotic therapy (e.g. meningitis)
• Beta-lactam allergy
• Previously enrolled
• Lack a mobile phone and/or unable to return for follow-up clinic visits during the next 24 months