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. 2006 Apr 19;2006(2):CD004979. doi: 10.1002/14651858.CD004979.pub2

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
Notes Non‐blinded evaluation of outcomes
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Low risk A ‐ Adequate