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Clinical Trial
. 2004 Apr 3;328(7443):791.
doi: 10.1136/bmj.38049.490255.DE. Epub 2004 Mar 16.

Three day versus five day treatment with amoxicillin for non-severe pneumonia in young children: a multicentre randomised controlled trial

Girdhar Agarwal, Shally Awasthi, S K Kabra, Annapurna Kaul, Sunit Singhi, Stephen D Walter; ISCAP Study Group
Clinical Trial

Three day versus five day treatment with amoxicillin for non-severe pneumonia in young children: a multicentre randomised controlled trial

Girdhar Agarwal et al. BMJ. .

Erratum in

  • BMJ. 2004 May 1;328(7447):1066

Abstract

Objective: To assess the efficacy of three days versus five days of treatment with oral amoxicillin for curing non-severe pneumonia in children.

Design: Randomised, double blind, placebo controlled multicentre trial.

Setting: Outpatient departments of seven referral hospitals in India.

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

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

Main outcome measures: 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.

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Figures

Figure 1
Figure 1
Flow of participants through each stage of the randomised trial
See this image and copyright information in PMC

Comment in

References

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