Augmentin ES Highly Effective in Curing and Controlling Symptoms of Children's Ear Infections
TORONTO, /PRNewswire/ -- A new high-dose formulation of Augmentin®(amoxicillin-clavulanate), called Augmentin® ES*, is highly effective in eradicating the three most common bacteria that cause middle ear infections in children, including drug-resistant strains, according to a new study presented this week at the 40th annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). The data show that Augmentin ES eradicated between 95 and 100 percent of Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis, while maintaining the safety profile of the currently marketed Augmentin.
Infections caused by drug-resistant bacteria have increased exponentially in recent years, making children's ear infections progressively more difficult to treat. According to the Centers for Disease Control and Prevention (CDC), the rate of S. pneumoniae (the most common bacteria causing middle ear infections) resistance to penicillin has increased by more than 300 percent over the past five years in the United States. In January 1999 the steady rise of drug resistant S. pneumoniae prompted the CDC to issue guidelines for the treatment of middle ear infections. The guidelines recommend high-dose Augmentin as one of three oral antibiotics to be used for treating middle ear infections.
'Augmentin ES will be an important antibiotic in the management of middle ear infections because of its efficacy in eradicating drug-resistant bacteria,' said Alejandro Hoberman, M.D., the Jack L. Paradise Endowed Chair of Pediatric Research at Children's Hospital of Pittsburgh, Associate Professor of Pediatrics at the University of Pittsburgh School of Medicine and one of the lead investigators of the study. 'To ensure that children's ear infections are treated effectively, physicians should select antibiotics based on their effectiveness in eradicating the infecting organisms.'
Study Shows Augmentin ES Highly Effective in Eradicating Resistant
Bacteria
In a multi-center trial, 521 children with middle ear infections, age 3-48 months, received Augmentin ES twice a day for 10 days. Bacterial eradication was measured by the repeat tympanocentesis method in patients where S. pneumoniae was present. This testing method involves culturing middle ear fluid before and after 4-6 days of initiating antibiotic therapy. Most experts consider this to be a more rigorous test of antibiotic efficacy than measurement of symptomatic improvement alone.
The data showed that Augmentin ES eradicated 97 percent of penicillin-resistant S. pneumoniae, and 100 percent of penicillin-susceptible and intermediate-resistant S. pneumoniae bacteria. Augmentin ES also eradicated 95 percent of H. influenzae and 100 percent of M. catarrhalis, including drug-resistant strains. H. influenzae and M. catarrhalis are known to produce an enzyme called beua-lactamase that renders these bacteria resistant to many antibiotics, including amoxicillin, penicillin and several cephalosporin antibiotics. Augmentin ES, which contains a substance called clavulanic acid, is specifically designed to inhibit beta-lactamase and therefore provides increased efficacy against H. influenzae and M. catarrhalis.
Clinical success rates in this study were also high, with Augmentin ES improving or eliminating the symptoms of middle ear infections in approximately 93 percent of children with infections caused by S. pneumoniae alone or in combination with other bacteria, including more than 90 percent of patients with infections caused by resistant S. pneumoniae. Clinical success also occurred in about 90 percent of children with infections caused by H. influenzae, M. catarrhalis, or Streptococcus pyogenes. Augmentin ES was well tolerated, maintaining the safety profile of the currently marketed Augmentin. The most commonly reported adverse experiences included diarrhea, vomiting, diaper rash and fever.
'Augmentin has remained an extremely effective treatment for ear infections for more than 16 years,' said Dr. Hoberman. 'The development of this new formulation, which includes a doubled dose of amoxicillin, will ensure appropriate management of middle ear infections in this era of increasing drug resistance.'
SmithKline Beecham has filed a new drug application to the U.S. Food and Drug Administration for Augmentin ES and is awaiting approval. Future availability of Augmentin ES is expected to simplify physician compliance with the CDC guidelines and therefore improve treatment outcomes.
Seventy-Five Percent of Children Experience Middle Ear Infections 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 out of four children experience at least one middle ear infection before they are three years old and of these, almost half experience three or more episodes. When an antibiotic that is not effective in killing all of the bacteria that cause an ear infection is used, the surviving bacteria may mutate and become resistant to that particular antibiotic, making future infections tougher to treat. In effort to combat this problem, the CDC issued guidelines which recommend the most effective antibiotics for middle ear infections. When an ear infection caused by bacteria is left untreated or treated with the wrong antibiotic, the infection is more likely to recur and on rare occasions may develop into a serious complication such as mastoiditis (swelling of the jaw bone), meningitis or permanent hearing loss.
Children's Hospital of Pittsburgh is one of the premier pediatric referral centers in the world. For more than 100 years, Children's Hospital has been committed to a three-part mission of providing high quality patient care, groundbreaking biomedical research and outstanding pediatric medical education. It is the only hospital in western Pennsylvania devoted solely to the care of infants and children and, with 235 licensed beds, serves the region of Ohio, West Virginia and western Pennsylvania.
* Augmentin ES contains twice the amount of amoxicillin (90/6.4 mg/kg/day) as traditional Augmentin (45/6.4 mg/kg/day) and therefore provides added efficacy against S. pneumoniae.
SOURCE Children's Hospital of Pittsburgh
CO: Children's Hospital of Pittsburgh; SmithKline Beecham
