Amoxicillin/potassium clavulanate is effective treatment for acute bacterial sinusitis in children

Article Outline

• Question
• Design
• Setting
• Participants
• Intervention
• Outcomes
• Main Results
• Conclusions
• Commentary
• References
• Copyright

Wald ER, Nash D, Eickhoff J. Effectiveness of amoxicillin/clavulanate potassium in the treatment of acute bacterial sinusitis in children. Pediatrics 2009;124:9-15.

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Question 

Among children diagnosed with acute bacterial sinusitis (ABS), how effective is high-dose amoxicillin/potassium clavulanate compared with placebo?

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Design 

Randomized, double-blind, placebo-controlled study.

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Setting 

Two private practices (1 urban, 1 rural) and a hospital-based clinic.

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Participants 

Children 1 to 10 years of age with a clinical presentation compatible with ABS were eligible. Patients were stratified according to age (<6 or ≥6 years) and clinical severity.

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Intervention 

Amoxicillin (90 mg/kg) with potassium clavulanate (6.4 mg/kg) or placebo.

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Outcomes 

A symptom survey was performed on days 0, 1, 2, 3, 5, 7, 10, 20, and 30. Patients were examined on day 14. Children's conditions were rated as cured, improved, or failed according to scoring rules.

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Main Results 

A total of 2135 children with respiratory complaints were screened for enrollment; 139 (6.5%) had ABS. Fifty-eight patients were enrolled, and 56 were randomly assigned. The mean age was 66 ± 30 months. Fifty (89%) patients presented with persistent symptoms, and 6 (11%) presented with nonpersistent symptoms. In 24 (43%) children, the illness was classified as mild, whereas in the remaining 32 (57%) children it was severe. Of the 28 children who received the antibiotic, 14 (50%) were cured, 4 (14%) were improved, 4 (14%) experienced treatment failure, and 6 (21%) withdrew. Of the 28 children who received placebo, 4 (14%) were cured, 5 (18%) improved, and 19 (68%) experienced treatment failure. Children receiving the antibiotic were more likely to be cured (50% vs 14%, number needed to treat = 3) and less likely to have treatment failure (14% vs 68%) than children receiving the placebo.

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Conclusions 

ABS is a common complication of viral upper respiratory infections. Amoxicillin/potassium clavulanate results in significantly more cures and fewer failures than placebo, according to parental report of time to resolution of clinical symptoms.

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Commentary 

Kudos to Drs. Wald, Nash, and Eickhoff for their exceptional study. They have tackled a difficult clinical issue in a logical and thorough manner. The diagnosis of ABS is fraught with problems, because sinus culture is neither appropriate nor practical in a clinical setting. This article gives the clinician a usable clinical severity score, which improves the diagnostic likelihood that the patient has ABS. Accurate diagnosis leads to less antibiotic usage, and this study can be presented to parents who insist that antibiotics be prescribed for their children who most likely have viral infections. As for antibiotic choices, amoxicillin/potassium clavulanate (90/6.4 mg/kg/day) is indeed one of the better choices for treating children with ABS because this agent provides better gram-negative coverage than amoxicillin alone for “first-line” therapy. Cefpodoxime was used for “rescue” therapy, because it has excellent activity against Haemophilus influenzae, and this was appropriate during the time period that the study was conducted (2004–2006). Subsequently, Streptococcus pneumoniae serotype 19A, resistant to all agents recommended for use in childhood ABS, has emerged as an unintended consequence of routine use of the conjugate pneumococcal vaccine.¹, ² The only oral agents with activity against this “superbug” are respiratory fluoroquinolones and linezolid. As we continue to see many children with upper respiratory tract symptoms, continued antimicrobial stewardship by the pediatrician will remain even more important, and this article is a strong advocate for responsible use.

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References 

1. Pelton SI, Huot H, Finkelstein JA, Bishop CJ, Hsu KK, Kellenberg J, et al. Emergence of 19A as virulent and multidrug resistant Pneumococcus in Massachusetts following universal immunization of infants with pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2007;26:468–472
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2. Critchley IA, Jacobs MR, Brown SD, Traczewski MM, Tillotson GS, Janjic N. Prevalence of serotype 19A Streptococcus pneumoniae among isolates from U.S. children in 2005-2006 and activity of faropenem. Antimicrob Agents Chemother. 2008;52:2639–2643
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