Three day versus five day treatment with amoxicillin for non-severe pneumonia in young children: a multicentre
Insights
A three-day course of oral amoxicillin is as effective as a five-day course for treating non-severe childhood pneumonia. This finding supports shorter antibiotic durations for pediatric pneumonia, improving adherence and potentially reducing side effects.
Area of Science:
- Pediatric infectious diseases
- Clinical pharmacology
- Respiratory medicine
Background:
- Pneumonia is a leading cause of childhood mortality globally.
- Optimal antibiotic duration for non-severe pneumonia in children is debated.
- Amoxicillin is a first-line treatment for childhood pneumonia.
Purpose of the Study:
- To compare the efficacy of 3-day versus 5-day oral amoxicillin treatment for non-severe pneumonia in children.
- To evaluate clinical cure rates and treatment failure in pediatric pneumonia patients.
Main Methods:
- Randomized, double-blind, placebo-controlled, multicenter trial involving 2188 children (2-59 months).
- Children received either 3 or 5 days of oral amoxicillin (31-54 mg/kg/day).
- Treatment failure defined by clinical signs, respiratory rate, or oxygen saturation.
Main Results:
- Clinical cure rates were similar: 89.5% for 3 days vs. 89.9% for 5 days.
- Treatment adherence was higher with the 3-day regimen (94% vs. 85%).
- Clinical failure was associated with respiratory syncytial virus and non-adherence.
Conclusions:
- Three days of oral amoxicillin is as effective as five days for non-severe childhood pneumonia.
- Shorter treatment durations may improve adherence and be a viable option.
- Further research can confirm optimal antibiotic courses for pediatric pneumonia.
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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