Clinical trial results show single-dose Zithromax® as effective as 10 days of Augmentin® in treating children's ear infections

September 13, 2000

A single-dose study shows promise for effective, short-course antibiotic therapy

New York, September 14, 2000 - Pfizer Inc said today that a new clinical study shows one single dose of Zithromax® (azithromycin for oral suspension) is as effective as Augmentin® (amoxicillin/clavulanate potassium), administered twice a day for 10 days, in treating acute otitis media in children. Results of the multicenter clinical trial were presented recently at the Infectious Diseases Society of America (IDSA) annual meeting in New Orleans, La.

The study found that the treatment response of children with middle ear infections who received a single dose of Zithromax® was clinically equivalent to the response of those treated with a 10-day course of Augmentin® (86 percent vs. 88 percent, respectively; p=.620). Seventy-five percent of patients in both drug groups achieved treatment success upon observation at 32 days (p=1.000).

Zithromax® is an oral antibiotic approved for use in children and adults; it achieves high and sustained levels in infected tissues making short course dosing possible.

The data necessary to include the single-dose regimen as an option for children with acute otitis media will be submitted to the U.S. Food and Drug Administration for review. The Zithromax® product label currently includes a 5-day, once daily dosing schedule that may make finishing medication easier than with conventional 10-day antibiotic regimens.

This randomized, double-blind trial conducted at nine U.S. centers evaluated 350 children between the ages of six months and 12 years with acute otitis media. Patients were randomized to receive either a 30 mg/kg single-dose of Zithromax® oral suspension or 45 mg/kg of Augmentin® twice a day for 10 days. The average age of children treated with Zithromax® was 2.7 years and 3.4 years for those in the Augmentin® group.

In the study, Zithromax(R)(azithromycin) was generally well tolerated, with 17 percent of patients in the Zithromax® drug group experiencing treatment-related adverse events as compared to 23 percent of those receiving Augmentin® More children discontinued due to adverse events when taking Augmentin® compared with Zithromax® (6 vs. 2 children, respectively). Additionally, twice as many children from the Augmentin® group experienced diarrhea versus those receiving Zithromax® (22 vs. 11 children, respectively). Vomiting, generally mild, occurred in seven children in each drug group.

"The results of this study indicate that a single oral dose of medication can accomplish what traditionally has taken up to 10 days; families and healthcare providers are likely to appreciate this alternative to conventional treatment," says Stephen Eppes, M.D., FAAP, associate director, Department of Pediatrics, Division of Infectious Diseases, Alfred I. duPont Hospital for Children, Wilmington, Del. "Likewise, the single-dose administration is likely to encourage improved patient compliance so that children are treated successfully the first time, reducing the risk of developing resistance to the antibiotic."

Acute otitis media is an inflammation of the middle ear (the space just behind the eardrum), and is often caused by bacteria. Other than colds or coughs, otitis media is the most common illness young children encounter, accounting for at least 30 million sick child visits to the doctor each year.

Because ear infections can occasionally cause temporary hearing loss and may impair speech and language skills, parents should understand the importance of seeking proper treatment. Physicians will often prescribe an antibiotic since bacteria are a frequent cause of ear infections. Most antibiotics require 10 days of multi-dose treatment. Children may not always finish the medication, a situation that can lead to possible treatment failure and may lead to the development of resistance to that medication.

Zithromax® (azithromycin for oral suspension) is indicated for acute otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis. The most common side effects in otitis media are diarrhea/loose stools (2 percent), abdominal pain (2 percent), vomiting (1 percent) and nausea (1 percent).

Zithromax® should not be taken by patients with hypersensitivity to azithromycin, erythromycin or any macrolide antibiotic. Please see attached prescribing information.
Zithromax® is manufactured by Pfizer Inc, a company that discovers, develops, manufactures and markets leading prescription medicines, for humans and animals, and many of the world's best known over-the-counter brands. This year, Pfizer expects global sales of more than $30 billion and has a research and development budget of $4.7 billion.

Augmentin (amoxicillin/clavulanate) is a registered trademark of SmithKline Beecham.

For more information about ear infections and Zithromax®, please visit or

Diane DiBello 212-601-8235

Porter Novelli

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