5-day Course of Antibiotics for Acute Otitis Media

By Joan Unger, RN, MS, ARNP-C

Summary—Between 65% and 95% of children will experience acute otitis media (AOM) before they reach 7 years of age, and 90% will receive a 10-day course of antibiotics. This study evaluated more than 2,000 children treated with short-course (fewer than seven days) or long-course (more than seven days) antibiotic therapy for AOM. Investigators looked at short-acting antibiotics as well as ceftriaxone sodium and azithromycin. The researchers concluded that five days of a short-acting antibiotic provided effective treatment for uncomplicated AOM in children. Exceptions to this include children under 2 years and those with perforated eardrums, chronic or recurring otitis media, underlying disease, or other high-risk findings.

Before they reach seven years of age, 65-95% of children will suffer at least one episode of painful acute otitis media (AOM). It is one of the most common diagnoses for children accessing health care and the most common indication for prescribing antibiotics in the United States. More than 90% of children with AOM will receive antibiotics for 10 days, which represents an estimated annual cost of managing AOM in the United States at more than $3.5 billion.1

Studies in 1995 in developed countries reported similar long-term outcomes in children with AOM whether treated or untreated with antibiotics.2 A recent meta-analysis found antibiotic treatment compared with placebo did shorten duration of acute symptom3 and, in a few trials, acute symptoms resolved with two to three days of antibiotic treatment.4

Researchers undertook this meta-analysis to learn if a shorter course of antibiotics (fewer than 10 days) might be effective treatment for AOM. They were careful to ensure quality and comparability of studies included for analysis. (For additional information, see box, p. 47.) A diagnosis of AOM was based on clinical signs and symptoms, and none of the subjects was on antibiotics when trials began.

Subjects were re-evaluated after initiation of therapy, at intervals of 8-19 days and 20-30 days. Primary outcomes were evaluated only at 20-30 days. Secondary outcomes were evaluated at 30-40 days and 120 days after initiating trials.

Outcome Analysis Supports Short-Course Therapy

Researchers expressed the risk of short-course antibiotic failure in comparison to long-course as an odds ratio (OR). An OR greater than 1 identified a greater number of failures with short-course antibiotics and greater success with long-course therapy.

• Comparison of treatment success with short-acting antibiotics given for 48 hours or less with those given for at least seven days resulted in an OR of 2.99.

• Outcomes of 1,549 children recorded 30 days after beginning treatment compared short-acting antibiotics given for five days with antibiotics given for 8-10 days and demonstrated a treatment failure OR of only 1.38.

• Primary outcomes of 2,115 children were evaluated at 20-30 days following treatment revealed no significant difference between 1,031 subjects given antibiotics for five days and 1,084 subjects treated for 8-10 days (OR 1.22).

• Researchers defined secondary outcomes as failures, relapses, and recurrences during the three months following therapy. The analysis found no significant difference between 539 children receiving short-course antibiotics and 515 given long-course treatment (OR 1.16).

• The study demonstrated that treatment failures at 30 days or less were no more common in the short-course antibiotic trials than in the long-course trials.

• Outcome comparisons after three months revealed no significant differences between the short- and the long-term treatment regimens.

Shorter Course of Antibiotics Advised

Analysis of risk difference indicates 44 children would require a long course of short-acting antibiotics to prevent one treatment failure in which the one child with persistent symptoms would be most likely to return to the health care provider. The authors cited studies supporting their belief that a shorter course of antibiotics was likely to protect children from developing resistant microorganisms.3,4

Researchers concluded that comparisons between different short-acting antibiotics did not change treatment outcomes. The analysis provides no supportable rationale for using azithromycin or ceftriaxone when cost and concern about indiscriminate use of broad-spectrum antibiotics are considered.

Potential for Gastrointestinal Problems?

No difference appeared in potential for gastrointestinal side effects between long- and short-course antibiotics, although children who received azithromycin were less likely to have gastrointestinal side effects than those who received a long-course antibiotic (most often amoxicillin-clavulanate).

The study authors concluded that the meta-analysis supported the use of five-day, short-acting antibiotic therapy for uncomplicated AOM when clinicians and parents decide to use antibiotics. They point out that a shortened course may reduce antibiotic use in areas that consider 10 days as standard therapy resulting in decreased cost, improved compliance, and decreased development of resistant organisms.

Practice Implications

This meta-analysis with a large study population suggests that a shortened-course five-day treatment with a short-acting antibiotic is effective treatment for uncomplicated AOM in children. Remember that the study authors note their findings can be safely applied to children who seek ambulatory care for uncomplicated AOM with some exceptions. The findings do not apply to children:

• with underlying disease;

• with recurrent or chronic otitis media.

They point out that subgroup sample sizes were too small to permit reliable estimates for risk of treatment failure with short-course antibiotics in children:

• younger than 2;

• with perforated tympanic membranes;

• and other high risk children.

As with any illness, a thorough history and careful diagnosis are keys to successful therapy. Parent education regarding the dangers of overprescribing antibiotics is essential. Telephone follow-up to ensure satisfactory resolution of infection is a wise precaution.

References

1. Kozyrskyi AL, Hildes-Ripstein GE, Longstaffe SE, et al. Treatment of acute otitis media with a shortened course of antibiotics. JAMA 1998;279:1736-1741.

2. Berman S. Otitis media in developing countries. Pediatrics 1995;96:126-131.

3. Cohen ML. Epidemiology of drug resistance. Science 1992;257:1050-1055.

4. Murray BE. Can antibiotic resistance be controlled? NEJM 1994;330:1229-1230.