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
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®(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
"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
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.