Three day versus five day treatment with amoxicillin for non-severe pneumonia in young children: a multicentre randomised controlled trial.
OBJECTIVE
To assess the efficacy of three days versus five days of treatment with oral amoxicillin for curing non-severe pneumonia in children.


METHODS
Randomised, double blind, placebo controlled multicentre trial.


METHODS
Outpatient departments of seven referral hospitals in India.


METHODS
2188 children aged 2-59 months, 1095 given three days of treatment and 1093 given five days.


METHODS
Oral amoxicillin 31-54 mg/kg/day in three divided doses.


METHODS
Treatment failure: defined as development of chest indrawing, convulsions, drowsiness, or inability to drink at any time; respiratory rate above age specific cut points on day 3 or later; or oxygen saturation by pulse oximetry < 90% on day 3.


RESULTS
The clinical cure rates with three days and five days of treatment were 89.5% and 89.9%, respectively (absolute difference 0.4 (95% confidence interval--2.1 to 3.0)). Adherence to treatment regimen was 94% and 85% for three day and five day treatments, respectively. Loss to follow up was 5.4% by day 5. There were no deaths, 41 hospitalisations, and 36 minor adverse reactions. There were 225 (10.3%) clinical failures and 106 (5.3%) relapses, and rates were similar in both treatments. At enrollment, 513 (23.4%) children tested positive for respiratory syncytial virus, and Streptococcus pneumoniae and Haemophilus influenzae were isolated from the nasopharynx in 878 (40.4%) and 496 (22.8%) children, respectively. Clinical failure was associated with isolation of respiratory syncytial virus (adjusted odds ratio 1.95 (95% confidence interval 1.0 to 3.8)), excess respiratory rate of > 10 breaths/minute (2.89 (1.83 to 4.55)), and non-adherence with treatment at day 5 (11.57 (7.4 to 18.0)).


CONCLUSIONS
Treatment with oral amoxicillin for three days was as effective as for five days in children with non-severe pneumonia.
Agarwal
Girdhar
G
Awasthi
Shally
S
Kabra
S K
SK
Kaul
Annapurna
A
Singhi
Sunit
S
Walter
Stephen D
SD
D000658:Amoxicillin / Q000008:administration & dosage* / Q000191:economics; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000191:economics; D002675:Child, Preschool; D003365:Costs and Cost Analysis; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D006801:Humans; D007223:Infant; D010349:Patient Compliance; D018410:Pneumonia, Bacterial / Q000188:drug therapy* / Q000191:economics; D012307:Risk Factors; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D000658:Amoxicillin