New Study Confirms Superiority of Augmentin to Zithromax in Treating Middle Ear Infections

Use of Appropriate Antibiotic Crucial for Effective Treatment in Era of Drug Resistance

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Augmentin(R) (amoxicillin/clavulanate), an oral antibiotic, is more effective than Zithromax(R) (azithromycin) in eradicating the most common bacteria that cause middle ear infections (acute otitis media, or AOM) in children, according to a new study published in the February issue of the Pediatric Infectious Disease Journal. The study also shows that Augmentin 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 clinical investigator Candice Johnson, M.D., of The Children's Hospital of Denver. "This study showed that a ten-day course of Augmentin was significantly more effective in killing bacteria and improving symptoms than a five-day course of Zithromax."

According to the Centers for Disease Control and Prevention (CDC), the bacteria Haemophilus influenzae and Streptococcus pneumoniae combined account for more than 70 percent of all middle ear infections. These bacteria are becoming increasingly resistant to antibiotics, with S. pneumoniae and H. influenzae resistance approaching 50 percent and 42 percent in the United States, respectively. A child with an ear infection caused by a resistant organism is at risk for developing a more serious illness, such as mastoiditis (a severe infection and swelling of the mastoid bone, which is located behind the ear), if effective antibiotics are not used. These study results support the most recent CDC treatment recommendations for AOM, which cite Augmentin as one of only three oral agents recommended for the treatment of this condition. The CDC does not include Zithromax in its treatment recommendations.

Ear Infections Highly Prevalent, May Cause Irreparable Damage
Next to the common cold, ear infections are the most common childhood illness and are responsible for more than 30 million doctor visits each year. Three of every four children experience at least one episode of otitis media before they're three years old, and almost half of these children have three or more episodes before age three. Some temporary hearing loss almost always accompanies fluid in the ear -- with or without infection. Therefore, chronic ear infections can reduce a child's hearing during a time that is critical for speech and language development. Additionally, on rare occasions an ear infection, if poorly treated, may lead to a ruptured eardrum, felt as a sharp pain and popping sensation, followed by fluid draining out of the ear. If a child has more than three or four ear infections per year or has a hearing loss due to persistent fluid for more than six months, it is often necessary for tubes to be surgically implanted into the child's ears to treat the infection.

Augmentin More Effective in Eradicating Bacteria
This is the first study of Augmentin compared to Zithromax to measure bacterial eradication (actual killing of the bacteria) by a "double tap" -- also known as double tympanocentesis. This testing method involves culturing middle ear fluid, and most experts consider it to be a more rigorous test of antibiotic efficacy than measurement of symptomatic improvement alone.

In this multicenter, randomized trial involving 238 children between the ages of six months to two years with AOM, participants received typical U.S. (United States) doses of Augmentin (45mg/kg/day in two divided doses for 10 days) or Zithromax (10mg/kg on day one followed by 5mg/kg every 24 hours on days two through five). At baseline, cultures were obtained from the middle ear fluid of all participants using a 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 4, 5 or 6 and tested to determine whether the antibiotic they received had successfully eradicated the infecting bacteria.

Analysis showed that Augmentin was significantly superior to Zithromax in eradicating all bacterial pathogens (83% vs. 49%). Specifically, Augmentin eradicated 87 percent of H. influenzae, versus 39 percent for Zithromax, a statistically significant difference, and 90 percent of S. pneumoniae bacteria, compared to 68 percent for Zithromax. Augmentin, which contains a substance called clavulanate potassium, is specifically designed to inhibit beta-lactamase, an enzyme produced by certain bacteria that can render many antibiotics ineffective.

Augmentin was also significantly more effective in terms of clinical outcomes, overall "curing" (complete resolution of) or "improving" (lessening of) symptoms in 86 percent of patients, versus 70 percent for Zithromax. More specifically, 90 percent of those infected with H. influenzae were considered either "cured" or "improved" at the end of the study, compared with 63 percent of the patients treated with Zithromax.

"Augmentin's superior bacterial eradication not only leads to more rapid clinical improvement, but it is also an insurance policy against the serious complications of otitis media," added Dr. Johnson. Both drugs in the study were well tolerated. The most commonly reported adverse experiences were vomiting, diarrhea, fever and rash.

The Children's Hospital, Denver The Children's Hospital of Denver is a private, not-for-profit pediatric health care system with more than 1,000 pediatric specialists and 1,700 full-time employees. The Children's Hospital of Denver was recently ranked in the top three percent of all hospitals nationally by U.S. News and World Report, which surveyed board-certified physicians on the top hospitals in their field. This year's vote represented the seventh year in a row that pediatricians ranked Children's a top hospital that cares for children.

CONTACT: The Children's Hospital of Denver

Feb. 1, 2000