ACTRN12616000046404
Completed
Phase 4
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
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Pneumonia in children
- Sponsor
- Menzies School of Health Research
- Enrollment
- 324
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Hospitalised children aged 3\-mo to \<6\-yrs (in Darwin, children have to be Indigenous)
- •(2\) Have features of severe pneumonia on admission (temperature \>37\.50C or a history of fever at home or observed at the referring clinic, age\-adjusted tachypnoea \[RR\>50 if \<12\-mo; RR\>40 if \>12\-mo] with chest wall recession and/or SpO2 \<92% in air), and consolidation on CXR as diagnosed by treating clinician
- •(3\) After 1\-3 days of IV antibiotics, are afebrile, with improved respiratory symptoms and signs, SpO2 \>90% in air and are ready to be switched to oral amoxicillin\-clavulanate, and
- •(4\) Have symptoms of no longer than 7 days at point of hospitalisation.
- •(5\) Recruited within 24 hours of admission to ward
Exclusion Criteria
- •(1\) Current wheeze
- •(2\) 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
- •(3\) Severe malnutrition (weight\-for\-height Z\-score \<\-3\)
- •(4\) Complicated (effusion, empyema or abscess) pneumonia, including tuberculosis
- •(5\) Extra\-pulmonary infection requiring antibiotic therapy (e.g. meningitis)
- •(6\) Beta\-lactam allergy
- •(7\) Previously enrolled
- •(8\) Lack a mobile phone and/or unable to return for follow\-up clinic visits during the next 24 months
Outcomes
Primary Outcomes
Not specified
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