APPIS Group 2004.
Methods | Multicentre, randomized, open‐label, equivalency study Intention‐to‐treat analysis for the main outcome Per protocol analysis for efficacy | |
Participants | N = 1702 n oral (O) = 857 n parenteral (P) = 845 % Male in group O = 62% group P = 63% Children, admitted to tertiary‐care centres in eight developing countries in Asia, Africa and South America Inclusion criteria: aged 3 to 59 months WHO defined severe pneumonia Exclusion criteria: asthma, lower chest in‐drawing resolved after two courses of inhaled salbutamol Danger signs of more severe disease and very severe pneumonia as defined by WHO | |
Interventions | Oral: amoxicillin syrup 45 mg/kg per day in three doses Parenteral: intravenous penicillin G crystalline 200.000 IU/kg per day in four doses | |
Outcomes | Treatment failure up to 48 hours defined as: appearance of danger signs such as inability to drink, abnormal sleepiness, central cyanosis, convulsions
Persistence of lower chest in‐drawing
Serious adverse drug reaction
Necessity of other antibiotic or
Death Follow up: causes of treatment failure were assessed each six hours for the first 48 hours. After discharge were assessed at five and 14 days after treatment was started |
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Notes | Non‐blinded evaluation of outcomes | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |