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There are few things more difficult for a parent than watching a baby or toddler be sick. Well, except for trying to get antibiotics into them. So for kids with acute otitis media, the promise of a short 5-day course of antibiotics, in comparison to the standard 10 days of amoxicillin would be welcome news. It would be good news for society too, as multiple studies have shown that shorter courses of targeted antibiotics may reduce the spread of resistant organisms.
But there’s no joy in Mudville today as a nicely performed clinical trial has fairly conclusively shown that a 5-day regimen for middle ear infections has struck out.
Appearing in the New England Journal of Medicine, this trial enrolled 515 children, all between birth and 2 years of age, with acute otitis media. Here's a picture.
There are some folks who recommend watchful waiting for older kids with middle ear infections, but the trend continues to be to treat the young ones.
Aside from the ear infection, these were healthy kids. They were randomized 1 to 1 to receive a 10-day course of amoxicillin/clavulanate versus a 5-day course followed by 5-days of placebo. The primary outcome was “clinical failure” – defined as persistent symptoms after the study treatment ended.
Clinical failure rates were a bit higher than expected in this study – 16% in the 10-day group and more than double that - 34% - in the 5-day group. Kids in the 10 day group had lower symptom scores after treatment as well.
You might expect to have seen more adverse events in the 10-day group, but no signal emerged there. Rates of diarrhea were 30% in both arms of the study.
As you might expect, kids in the 5-day group got less exposure to antibiotics, even accounting for rescue medication, but that fact hardly seems to trump the significantly higher clinical failure rate.
Interestingly, nasal carriage of penicillin-resistant organisms didn’t seem to change too much in either group. The study might not have been large enough to detect relevant alterations in bacterial resistance patterns though.
So it looks like we’re stuck with 10 days of amox/clav for now.
The trend towards shorter antibiotic courses has been encouraging as we continue to fight the spread of antibiotic resistance. But as my wife told me when I was studying for the nephrology boards – five days might not be long enough.