March 2000
DENVER - Amoxicillin/clavulanate (Augmentin, SmithKline Beecham) is more effective than azithromycin (Zithromax, Pfizer) in eradicating the most common bacteria that cause acute otitis media (AOM) in children, according to a new study published recently in the Pediatric Infectious Disease Journal
The study also showed that amoxicillin/clavulanate is more effective in reducing or curing the symptoms associated with AOM.
"Because we have entered this era of drug resistance, physicians should select an antibiotic based on its ability to eradicate the infecting organism, not duration of therapy, convenience or taste," said Candice Johnson, MD, clinical investigator at Children's Hospital of Denver.
"This study showed that a 10-day course of Augmentin was significantly more effective in killing bacteria and improving symptoms than a five-day course of Zithromax," she said.
Haemophilus influenzae and Streptococcus pneumoniae combined account for more than 70% of all middle ear infections. These bacteria are becoming increasingly resistant to antibiotics, with S. pneumoniae and H. influenzaeresistance approaching 50% and 42% in the United States, respectively.
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In this multicenter, randomized trial of 238 children between the ages of 6 months and 2 years with AOM, participants received typical U.S. doses of amoxicillin/clavulanate (45 mg/kg/day in two divided doses for 10 days) or azithromycin (10 mg/kg/day on day one and 5 mg/kg/day on days two through five). At baseline, cultures were obtained from the middle ear fluid of all participants who underwent tympanocentesis.
The fluid was tested for the presence of H. influenzae, S. pneumoniae and other pathogens. In children with an initial positive bacterial culture, an additional culture was obtained on days four, five and six to determine whether the antibiotic they received had successfully eradicated the infecting bacteria.
Analysis showed that amoxicillin/clavulanate was significantly superior to azithromycin in eradicating all bacterial pathogens (83% vs. 49%). Specifically, amoxicillin/clavulanate eradicated 87% of H. influenzae vs. 39% for azithromycin and 90% of S. pneumoniae bacteria, compared with 68% for azithromycin. Amoxicillin/clavulanate is specifically designed to inhibit ß-lactamase.
Amoxicillin/clavulanate resulted in complete resolution of or lessening of symptoms occurring in 86% of patients, vs. 70% for azithromycin. More specifically, 90% of those infected with H. influenzae were considered either "cured" or "improved" at the end of the study, compared with 63% of the patients treated with azithromycin.
The reported adverse events were vomiting, diarrhea, fever and rash.
For more information:
- Dagan R, Johnson CE, McLinn S. Bacteriologic and clinical efficacy of amoxicillin/clavulanate vs. azithromycin in acute otitis media. Pediatr Infect Dis J. 000;19:95-104.
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