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Researchers Find Amoxicillin/Clavulanate More Effective Than Azithromycin for Acute Otitis Media

PITTSBURGH, Sept. 14 /PRNewswire/ -- In a large study of young children with acute otitis media (AOM, or middle ear infections), clinical and bacteriologic outcomes with Augmentin ES-600™ (amoxicillin/clavulanate) were statistically significant and more favorable compared to Zithromax® (azithromycin), two of the most frequently prescribed antibiotics for the treatment of AOM in children.

Ninety-one percent of the children treated with Augmentin ES-600 showed improvements or were cured at the end of therapy versus 81 percent for Zithromax. Furthermore, bacterial pathogens that cause ear infections were eradicated from 94 percent of children during treatment with Augmentin ES-600, versus only 65 percent of children on Zithromax. A 37 percent difference in favor of Augmentin ES-600 was also shown in eradicating penicillin-resistant Streptococcus pneumoniae. Findings from the study (abstract 2324) were presented today at the 43rd Annual Meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), the world's premier meeting on infectious diseases and antimicrobial agents organized by the American Society for Microbiology.

Acute otitis media, an infection or inflammation of the middle ear, is one of the most common infections in children between the ages of 3 months and 3 years, and is the number one cause for doctor visits leading to approximately 30 million doctor visits each year. The three most frequent bacteria that cause AOM, Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis, have all become increasingly resistant to antibiotics. This leads to increased treatment failure and recurrent infections. Half of children who experience an ear infection before the age of 3 will experience repeated episodes of infection.

"Antibiotic resistance is a serious public health concern, especially for children suffering from AOM," said Alejandro Hoberman, MD, chief of the Division of General Academic Pediatrics at Children's Hospital of Pittsburgh, and lead investigator of the study. "As infections caused by drug-resistant bacteria have exponentially increased in the last decade, the significantly higher efficacy of Augmentin ES-600 compared to Zithromax demonstrates how the selection of an appropriate antibiotic can be a crucial step in preventing the increase of antibiotic resistance in this common pediatric condition."

Augmentin ES-600 More Effective than Zithromax Against Bacterial Pathogens

In a large multi-center trial, 731 children ages 6-30 months with AOM were randomly selected to receive either 90/6.4 mg/kg/day of Augmentin ES-600 twice a day for 10 days, or 10 mg/kg Zithromax on the first day and 5 mg/kg for the following four days. The investigators evaluated patients during, at the end of, and one to two weeks following treatment.

For each comparison, the proportion of patients showing clinical cure or improvement during and after treatment was statistically superior with Augmentin ES-600 than with Zithromax. Treatment with Augmentin ES-600 and with Zithromax respectively, resulted in clinical success in 95 percent of children versus 88 percent during treatment, in 91 percent versus 81 percent at the end-of-treatment visits, and 80 percent versus 71 percent at follow-up visits.

Specifically, AOM pathogens were eradicated from 94 percent of the children during treatment with Augmentin ES-600, versus only 65 percent of children on Zithromax. Augmentin ES-600 successfully eradicated the most difficult strains of bacteria to treat, penicillin-resistant Streptococcus pneumoniae, 37 percent more than Zithromax (92 percent versus 55 percent). Streptococcus pneumoniae and Haemophilus influenzae -- the two most common pathogens -- were respectively eradicated in 96 percent and 90 percent of children on Augmentin ES-600, versus only 80 percent and 49 percent of those on Zithromax, a more than 40 percent difference in Haemophilus influenzae coverage.

"The findings show that, in the midst of this challenging clinical situation, use of effective antibiotics is crucial to effectively eradicate hard-to-treat pathogens and prevent recurrent infections," Dr. Hoberman said. "Bacterial eradication is a key element in reducing treatment failures and repeated infections. This study clearly differentiates Augmentin ES-600 from Zithromax as a more successful treatment."

Both treatments showed a good safety profile, with diarrhea occurring in 6 percent of children on Augmentin ES-600 and in 4 percent of those on Zithromax.

Antibiotic Resistance, a Public Health Concern

Bacterial resistance to antibiotics has dramatically increased in recent years. According to the U.S. Centers for Disease Control and Prevention (CDC), in Streptococcus pneumoniae the rate of penicillin resistance has increased by more than 300 percent over the past five years in the United States. Data show that for S. pneumoniae, the incidence of penicillin resistance is 40 to 50 percent for children under 2 years old in the United States.

Antibiotic resistance occurs when bacteria that cause infection are not all killed by antibiotics. The surviving bacteria may mutate and make themselves resistant to that particular antibiotic. As a result, the same antibiotic may not be effective if used again. Bacteria that are resistant to antibiotics linger in the body, leading to longer or more serious illnesses.

The Prevalence of Acute Otitis Media

Three out of four children experience at least one AOM before they are 3 years old. Acute otitis media usually develop following an upper respiratory infection. However, certain factors increase a child's risk of experiencing repeat episodes of AOM caused by resistant bacteria including age, day care attendance and prior exposure to antibiotics, as well as lack of breast feeding and exposure to tobacco smoke.

Using an effective antibiotic for the eradication of bacteria from the infection site is important because when surviving bacteria re-grow or mutate and become resistant to that particular antibiotic, future infections are more difficult to treat. On rare occasions improperly treated ear infections may develop into a serious complication such as mastoiditis (infection of the skull adjacent to the ear), meningitis or permanent hearing loss.

Program funding and ongoing administrative and technical support is provided by GlaxoSmithKline.

Source: Children’s Hospital of Pittsburgh

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