Trial on the Ideal Duration of Oral Antibiotics in Children With Pneumonia
Pneumonia
About this trial
This is an interventional treatment trial for Pneumonia focused on measuring Pneumonia, Child, Outcome, Antibiotics, Etiology
Eligibility Criteria
Inclusion Criteria:
Children admitted with severe pneumonia as defined by the presence of all the following as defined as below:
- 3 months to 59 months old
- History of cough and/or shortness of breath
- Unwell for <= 7 days -Increased respiratory rate ( ≥ 50/min if ≤12 months old, ≥ 40/min) or retractions,-
- Any of the following signs/symptoms are present at examination that would necessitate admission: chest retractions, cyanosis, saturation< 92% on air, poor feeding or lethargy
- Documented fever (axillary /central temp ≥ 38/38.5°C) within 24 hrs of admission
- Abnormal CXR with presence of alveolar infiltrates
- Responds to IV antibiotics by the first 72 hrs and able to go home with oral antibiotics i.e. no more hypoxia and afebrile and reduced respiratory symptoms
Exclusion Criteria:
Children who (a) are transferred from another hospital (b) refuse blood taking (c) have a doctor diagnosis of asthma or recurrent wheezing illness (d) have a diagnosis of bronchiolitis i.e. wheezing in a child with a CXR with no consolidation (e) not acute illness ( ie >7 days) (f) unable to come for follow-up (g) not community acquired pneumonia e.g. aspiration pneumonia (h)complicated pneumonia with effusion, pneumothorax, clinical suspicion of necrotizing pneumonia (i)PICU admission or use of Non-invasive ventilation (j)significant comorbidities that can increase the risk of having a complicated pneumonia- (k) need for use of other antibiotics like anti-staph or macrolides (l)extra-pulmonary infection e.g. meningitis (m)allergy to penicillin (n) unable to tolerate oral antibiotics (o) underlying illness that can predispose to recurrent pneumonia
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Sites / Locations
- University Malaya Medical Centre
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Amoxicillin-Potassium Clavulanate
Placebo
Patient will be on amoxicillin-clavulanate 22.5mg/kg/dose bd for 10 days
Patient will be on amoxicillin-clavulanate 22.5mg/kg/bd for 3 days followed by another 7 days of placebo medication given at the same dose and frequency