A single IM dose of ceftriaxone has been proposed to be an effective alternative to oral antibiotic therapy for acute otitis media in young children.1 However, the few studies of this therapy to date have been relatively small, and conclusions have been made cautiously. In the present study, Barnett et al evaluated 484 young children, aged 3 months to 3 years, with acute otitis media. The children were randomized to receive either ceftriaxone 50 mg/kg IM single dose, or trimethoprim-sulfamethoxazole (TMP-SMX) 8 mg/kg/d of TMP and 40 mg/kg/d of SMX divided into two doses per day for 10 days. Study investigators, but not the patients or their parents, were blinded to the medication. Treatment failure was defined as persistence or recurrence of symptomatic illness together with the presence of a middle-ear effusion.
After three days of treatment, the TMP-SMX group had a significantly lower failure rate than the ceftriaxone group (4.9% vs 7.5%). At 14 days, however, there was no difference in failure rate (17.9% vs 19.8%). New-onset diarrhea was significantly more common in the TMP-SMX group (23.6% vs 9.2%). Eight percent of the ceftriaxone group reported pain at the injection site at day 3; none of these cases developed complications or required specific treatment. The authors conclude that single-dose IM ceftriaxone is equivalent in efficacy to a 10-day course of oral TMP-SMX. (Barnett ED, et al. Comparison of ceftriaxone and trimethoprim-sulfamethoxazole for acute otitis media. Pediatrics 1997;99:23-28.)
COMMENT BY DAVID J. KARRAS, MD
Several factors make it very difficult to compare the effectiveness of antibiotics in the treatment of otitis media. About 80% of cases of otitis will resolve spontaneously, making it necessary to enroll large numbers of subjects simply to distinguish antibiotic effect from placebo effect.2 Another problem is that many antibiotics have excellent activity against the common pathogens in otitis media, making for very subtle inter-drug differences in efficacy. Most studies that attempt to compare antibiotic effectiveness in otitis media report no significant differences between the drugs. Failure to find a difference, however, is not the same as proof of therapeutic equivalence.
The authors of this study use statistical techniques specifically designed to test for equivalence of drug efficacy. They defined therapeutic equivalence as less than 10% difference in outcome, a far stricter standard than that used in most other otitis studies. By this criterion, the authors have proven that ceftriaxone is indeed equally as effective as TMP-SMX, which in turn has been shown to be at least as effective as any other oral antibiotic. While many physicians object to IM therapy for uncomplicated otitis as cruel and unnecessary, the parents of patients in this study actually expressed greater satisfaction with the single-dose therapy than with oral therapy. Ceftriaxone would certainly be attractive in cases where compliance is believed to be a major barrier to treatment success.
References
1. Green SM, Rothrock SG. Single-dose IM ceftriaxone for acute otitis media in children. Pediatrics 1993;91:23-30.
2. Rosenfeld RM, et al. Clinical efficacy of antimicrobial drugs for acute otitis media: Meta-analysis of 5400 children from 33 randomized trials. J Pediatr 1994;154:355-367.
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