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Abstract
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.
Acknowledgements
The authors are indebted to the pediatricians and nurses of the Professor Hosannah de Oliveira Pediatric Center, Federal University of Bahia, Salvador, Brazil, and to NP Ribeiro, RN and AF Salgado for their cooperation in recruiting the patients.
The authors would also like to acknowledge the contribution from the PNEUMOPAC-Efficacy Study Group Phase I which consisted of: DA Braga, GXP Costa, GVS Nogueira, ÍS Oliveira, LB Neiva, SF Câmara, UR Sirmos, and VF Araújo from the Department of Pediatrics, Federal University of Bahia School of Medicine, Salvador, Bahia, Brazil; I Lorgetto, INR Costa, J Araripe, and JRM Vieira from Bahiana School of Medicine, Bahiana Foundation for Science Development, Salvador, Bahia, Brazil and Solange Carneiro from the Pharmacy Unit, Federal University of Bahia Hospital, Salvador, Bahia, Brazil.