A 3-day regimen of amoxicillin for children with non-severe pneumonia is as effective as a 5-day regimen, according to the findings of a double-blind, placebo controlled, randomised trial conducted in India.

Professor Shally Awasthi, King George's Medical University, Lucknow, India, and colleagues assessed the efficacy of 3- and 5-day regimens of oral amoxicillin (31-54 mg/kg/day in 3 divided doses) in 2,188 children, from 2 to 59 months old, with non-severe pneumonia. Inclusion criteria included respiratory rate of 50 or more breaths per minute for children aged from 2 to 11 months and 40 or more breaths per minute for those aged from 12 to 59 months, and no indication of severe illness, asthma, allergy to penicillin, measles within the previous month, or use of antibiotics within the previous 2 days.

Baseline testing identified 23.4% of the patient population with respiratory syncytial virus, as well as 40.4% with Streptococcus pneumoniae and 22.8% with Haemophilus influenzae in the nasopharynx.

Of the 1,095 children in the 3-day group adherence to treatment at day 3 was 94.2% and at day 5 was 85.6%. Patients in this group took matching placebo for the last treatment days. Adherence to treatment was 93.9% at day 3 and 84.9% at day 5 among the 1,093 children in the 5-day group.

The intention-to-treat analysis showed clinical cure rates of 89.5% in the 3-day group and of 89.9% in the 5-day group, while the per protocol analysis revealed clinical cure rates of 94.9% and 95.8% in the 3-day and 5-day groups, respectively.

Relapse rates, assessed between 12 and 14 days after enrolment, were 5.3% in the 3-day group and 4.4% in the 5-day group. Logistic regression analysis showed adjusted odds ratios for clinical failure of 11.57 for non-adherence at day 5, 2.89 among those with a respiratory rate >10 breaths/minute, and 1.95 for positivity for respiratory syncytial virus.

"We recommend the three day course of amoxicillin for treating community acquired non-severe pneumonia in children," the authors write, "as this is equally as effective as a five day course."

Three day versus five day treatment with amoxicillin for non-severe pneumonia in young children: a multicentre randomised controlled trial.
BMJ. 2004 Apr 3;328(7443):791. Epub 2004 Mar 16.
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