Single-Dose Treatment of Acute Otitis Media

Abstract & Commentary

Synopsis: A single intramuscular dose of ceftriaxone provided efficacy comparable to that of a 10-day course of trimethoprim-sulfamethoxazole in the treatment of acute otitis media.

Source: Barnett ED, et al. Comparison of ceftriaxone and trimethoprim-sulfamethoxazole for acute otitis media. Pediatrics 1997;99:23-28.

Barnett and colleagues in the greater Boston Otitis Media Study Group randomized children aged 3 months to 3 years with acute otitis media (AOM) to receive either a single intramuscular injection of ceftriaxone or 10 days of orally administered trimethoprim-sulfamethoxazole (TMP/SMX). The maximum dose of ceftriaxone was 50 mg/kg and was administered with lidocaine; the dose of TMP/SMX oral suspension was 8 mg trimethoprim and 40 mg sulfamethoxazole/kg/day in two divided doses. The diagnosis of AOM required evidence of acute illness together with objective evidence of middle ear effusion by pneumatic otoscopy.

Of the 596 randomized children, 494 were evaluable. After three days of treatment, the results slightly favored TMP/SMX treatment: Clinical cure (effusion could still be present) was achieved in 92.5% of the ceftriaxone and in 95.1% of the TMP/SMX group. Cure rates were, however, equivalent at days 14 and 28 ("treatment failure" at these times occurred if there were new signs of illness plus the presence of effusion). Thus, the cure rates at 14 days were, respectively, 82.0% and 82.1% and at 28 days were 79.4% and 80.0%. Persistence of middle ear effusion was observed at day 28 in 38.8% of those given ceftriaxone and 43.4% of those given TMP/SMX (P = 0.48).

Pain at the injection site was reported in 8.4% of ceftriaxone recipients at day 3. New onset diarrhea was reported by the parents in 23.6% of those given ceftriaxone and 9.2% of those given TMP/SMX (P < 0.001). New onset rash was seen in 10.2% of ceftriaxone and 7% of TMP/SMX recipients (P = 0.245). Compliance with TMP/SMX was at least 69%; compliance in the other 31% could not be assessed because the parents did not return drug diaries or pill bottles.

COMMENT BY STAN DERESINSKI, MD, FACP

The deficits in this study include lack of microbiological data and lack of a placebo. Nonetheless, its results reflect outcomes likely to be seen in the "real world," except for the possibility that compliance with TMP/SMX therapy may have been artificially high because of participation in a study.

The authors reported elsewhere that 21% of pediatric nasopharyngeal isolates of Streptococcus pneumoniae were resistant to TMP/SMX during the same period of time in Boston. This is a finding that should have biased the results in favor of ceftriaxone treatment. Nonetheless, no important overall difference in results of treatment could be detected between the two treatment groups.

It is possible, in fact, that much shorter durations of TMP/SMX administration may produce similar efficacy, as has been demonstrated with both penicillin and amoxicillin (BMJ 1982;284:1078-1081; Acta Otolaryngol 1983;96:99-104). Interpretation of results in the absence of a group not receiving antibiotic therapy is complicated by a known high rate of spontaneous resolution of AOM.

Overall, these results suggest that parents may be offered the choice of treating their child with AOM with either a single dose of ceftriaxone intramuscularly or a multiple-day course of treatment with TMP/SMX orally. The ever-increasing antimicrobial resistance among the pneumococcus, however, makes this conclusion one that must be constantly reevaluated.