1. Reducing the duration of antibiotic treatment for acute otitis media (AOM) in children aged 6-23 months was associated with a higher rate of clinical failure compared to the standard duration of treatment.
2. Clinical failure was significantly higher in children with bilateral AOM compared to unilateral AOM irrespective of treatment duration.
Evidence Rating: 1 (Excellent)
Study Rundown: AOM is the most frequently diagnosed and most common illness cited for antimicrobial treatment in children. The current recommendation is 7-10 days of antibiotic treatment, though shorter duration of treatment may be equally effective. This study compared the effects of shorter antibiotic duration (5 days) in children age 6-23 months for AOM with standard treatment (10 days).
The study results demonstrated that children in the 5-day group experienced significantly higher rates of treatment failure compared to those in the standard 10-day treatment group. There was a significantly higher mean symptom score in the 5-day group compared to the standard group. A significantly higher percentage of the standard group reported a decrease in symptoms compared to the 5-day group. In patients with bilateral AOM, duration of treatment did not significantly alter the rate of treatment failure.
Click to read the study, published today in NEJM
Relevant Reading: The Diagnosis and Management of Acute Otitis Media
In-Depth [randomized controlled trial]: A total of 896 children were eligible to participate in the study, with 520 undergoing randomization. Participants were 6-23 months of age and were required to have received at least 2 doses of pneumococcal conjugate vaccine and have an AOM diagnosis based on the time of onset and the AOM-SOS scale. The participants were randomly divided into two groups. The participants either received the standard 10-day course of amoxicillin-clavulanate or received a 5-day course followed by 5 days of placebo.
Overall, 34% of children in the 5-day treatment group had clinical failure compared to 16% in the 10-day group (difference 17%; 95%CI 9-25; NNT = 6). The mean symptoms score was significantly greater in the 5-day group compared to the 10-day group (1.89 vs. 1.20; p = 0.001). Clinical failure rates were higher if the child had been exposed to three or more children for 10 or more hours per week compared to those who had less exposure (p = 0.02). Furthermore, clinical failure was higher in children with bilateral AOM compared to unilateral AOM irrespective of treatment duration (p < 0.001). There were no significant differences between the two groups in the rates of recurrence, adverse events, or nasopharyngeal colonization with penicillin non-susceptible pathogens. Diarrhea and dermatitis were the most frequently cited side effects noted.
Image: PD
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