35563
document
Does 3-day course of oral amoxycillin benefit children of non-severe pneumonia with wheeze : a multicentric randomised controlled trial . BACKGROUND WHO-defined pneumonias , treated with antibiotics , are responsible for a significant proportion of childhood morbidity and mortality in the developing countries . Since substantial proportion pneumonias have a viral etiology , where children are more likely to present with wheeze , there is a concern that currently antibiotics are being over-prescribed for it . Hence the current trial was conducted with the objective to show the therapeutic equivalence of two treatments ( placebo and amoxycillin ) for children presenting with non-severe pneumonia with wheeze , who have persistent fast breathing after nebulisation with salbutamol , and have normal chest radiograph . METHODOLOGY This multi-centric , randomised placebo controlled double blind clinical trial intended to investigate equivalent efficacy of placebo and amoxicillin and was conducted in ambulatory care settings in eight government hospitals in India . Participants were children aged 2-59 months of age , who received either oral amoxycillin ( 31-54 mg/Kg/day , in three divided doses for three days ) or placebo , and standard bronchodilator therapy . Primary outcome was clinical failure on or before day- 4 . PRINCIPAL FINDINGS We randomized 836 cases in placebo and 835 in amoxycillin group . Clinical failures occurred in 201 ( 24.0 % ) on placebo and 166 ( 19.9 % ) on amoxycillin ( risk difference 4.2 % in favour of antibiotic , 95 % CI : 0.2 to 8.1 ) . Adherence for both placebo and amoxycillin was > 96 % and 98.9 % subjects were followed up on day- 4 . Clinical failure was associated with ( i ) placebo treatment ( adjusted OR = 1.28 , 95 % CI : 1.01 to1.62 ) , ( ii ) excess respiratory rate of > 10 breaths per minute ( adjusted OR = 1.51 , 95 % CI : 1.19 , 1.92 ) , ( iii ) vomiting at enrolment ( adjusted OR = 1.49 , 95 % CI : 1.13 , 1.96 ) , ( iv ) history of use of broncho-dilators ( adjusted OR = 1.71 , 95 % CI : 1.30 , 2.24 ) and ( v ) non-adherence ( adjusted OR = 8.06 , 95 % CI : 4.36 , 14.92 ) . CONCLUSIONS Treating children with non-severe pneumonia and wheeze with a placebo is not equivalent to treatment with oral amoxycillin . TRIAL REGISTRATION ClinicalTrials.gov NCT00407394 .
35564
Intervention_Pharmacological
oral amoxycillin
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Intervention_Control
placebo
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Intervention_Pharmacological
amoxycillin
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Intervention_Control
placebo
35568
Intervention_Pharmacological
amoxicillin
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Intervention_Pharmacological
amoxycillin
35570
Intervention_Pharmacological
standard bronchodilator therapy
35571
Intervention_Pharmacological
amoxycillin
35572
Intervention_Pharmacological
amoxycillin
35573
Intervention_Pharmacological
amoxycillin
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Outcome_Other
clinical failure on or before day- 4
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Outcome_Other
Clinical failures
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Outcome_Mental
Adherence
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Outcome_Other
Clinical failure
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Outcome_Physical
excess respiratory rate of > 10 breaths per minute
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Outcome_Physical
vomiting at enrolment
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Outcome_Physical
history of use of broncho-dilators
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Outcome_Mental
non-adherence
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Participant_Age
children
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Participant_Condition
non-severe pneumonia
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Participant_Condition
wheeze
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Participant_Age
children
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Participant_Condition
non-severe pneumonia
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Participant_Condition
wheeze
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Participant_Age
children
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Participant_Age
2-59
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Participant_Sample-size
836
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Participant_Sample-size
835
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Participant_Age
children
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Participant_Condition
non-severe pneumonia
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Participant_Condition
wheeze