Written by Seth Walsh-Blackmore
Spoon Feed
Children with persistent or worsening rhinosinusitis experienced a modest improvement in symptoms when given amoxicillin-clavulanate vs. placebo.
I see your child has been reading the guidelines.
Following AAP sinusitis guidelines* can reduce inappropriate antibiotic prescribing and associated harms. This study answered two questions: Do children without bacterial colonization or without colored nasal discharge benefit from antibiotics vs those who are colonized or who have colored discharge?
This multicenter RCT included children 2 to 11 years with persistent (11 to 30 days without improvement) or worsening (days 6 to 10 if initial improvement) rhinosinusitis symptoms, as defined by pediatric rhinosinusitis symptom scale (PRSS). Participants required a score ≥9 (out of 40), not due to asthma or allergies, as determined by a clinician at presentation. Those with severe rhinosinusitis per guidelines*, co-infections (i.e., strep, otitis media), comorbidities/immunosuppression, or recent antibiotic use (< 15 days) were excluded.
515 were randomized to 10 days of placebo or amoxicillin-clavulanate (90mg/kg/d). PRSS scores were recorded nightly by caregivers via an electronic diary. Analysis was by intention to treat. The trial did not meet the sample estimate of ≥344 per group for adequate power (β=0.8) due to a COVID-19 enrollment halt.
In a proportional hazard model of the first ten days after randomization, the antibiotic group experienced an average adjusted between-group difference in PRSS score of -1.69 (95%CI -2.07 to -1.31) compared to placebo.
There was more diarrhea (number needed to harm = 16) with antibiotics but more treatment failure (NNH = 8) with placebo. There were no significant differences in additional childcare costs, missed work, or additional healthcare visits. There were no severe events.
At randomization, participants were tested for S pneumoniae, H influenzae, and M catarrhalis. This was a significant interaction variable for antibiotic effect on mean PRSS score: -1.95 (95%CI -2.40 to -1.51) when detected vs -0.88 (-1.63 to -0.12) when not. Note, a PRSS score difference <1 is not clinically meaningful. Colored nasal discharge was not a significant interaction variable (p=0.52). If M catarrhalis was excluded and only S pneumoniae and H influenzae were considered, the effect was even more pronounced (meaning M catarrhalis is likely just a colonizer).
How will this change my practice?
Though underpowered, a favorable effect of antibiotic treatment was detected. Given the risk of treatment failure reported, I will use amoxicillin-clavulanate in this population.
Source
Identifying Children Likely to Benefit From Antibiotics for Acute Sinusitis: A Randomized Clinical Trial. JAMA. 2023;330(4):349-358. doi:10.1001/jama.2023.10854
Editor’s note | 3 practical applications of this study:
- Use AAP sinusitis guidelines* to determine whom to treat.
- Included children met AAP sinusitis criteria, and 71% of them grew a bacterial pathogen at enrollment. We don’t have great point-of-care rapid tests for S pneumoniae and H influenzae, which leaves ~30% of kids who meet guideline criteria yet are unlikely to benefit from antibiotics. This is likely why the AAP recommends immediately treating children with severe symptoms/signs or worsening but offering observation for 3 more days to children with persistent symptoms.
- I would be leery if it was just the symptom score that improved with amoxicillin/clavulanate; however, treatment failure rate, use of additional antibiotics, and development of acute otitis media were also lower, though at the cost of some diarrhea. So, I think there is some patient-centered benefit when treating the right patients. ~Clay Smith
*The AAP says, “The diagnosis of acute bacterial sinusitis is made when a child with an acute URI presents with (1) persistent illness (nasal discharge [of any quality] or daytime cough or both lasting more than 10 days without improvement), (2) a worsening course (worsening or new onset of nasal discharge, daytime cough, or fever after initial improvement), or (3) severe onset (concurrent fever [temperature ≥39°C/102.2°F] and purulent nasal discharge for at least 3 consecutive days).”
