Objective: To estimate the clinical failure and adverse events in children with nonsevere pneumonia receiving amoxicillin, identifying risk factors.
Research design/methods: 192 patients aged 2 - 59 months were prospectively followed up. Pneumonia diagnosis was based on respiratory complaints and radiographic pulmonary infiltrate or pleural effusion. Amoxicillin (50 mg/kg/day) was given. Demographic data and clinical findings on admission, daily evolution up to the 5th day of treatment and 2 - 4 weeks after enrollment were collected.
Main outcome measures: Clinical failure included persistence of fever, difficulty breathing or tachypnea beyond the first 48 h of treatment or of cough beyond the first 96 h of treatment or sign of severe/very severe disease up to the 5th day of treatment.
Results: Amoxicillin failed in 6 (3.1%) cases. By excluding one child diagnosed with cystic fibrosis after continued follow-up, the final clinical failure rate was 2.6%. The total adverse effect frequency was 14 (7.3%), but amoxicillin was discontinued only in 1 (0.5%) case. No relapse was identified at the 2 - 4-week interval evaluation. By multivariate analysis, age (OR = 1.1; 95% CI 1.01 - 1.19) was an independent risk factor for clinical failure which occurred in older children (47 +/- 9 vs 31 +/- 16 months; p = 0.01).
Conclusions: Clinical failures were few, especially among those aged < 2 years. Amoxicillin discontinuation due to adverse reaction was rare.