High-risk children with acute recurrent otitis media who have failed on other antibiotics-the type of children usually excluded from clinical drug trials-do well on oral cefprozil (Cefzil, BristolMyers Squibb), a new study contends.
The typical patient assessed had experienced three or four previous ear infections and had been on multiple drugs.
"Symptoms of ear pain, fever, and irritability improved or resolved in three to six days in over 95% of the 262 evaluable high-risk children in our multicenter study," reported Samuel E. McLinn, M.D., FAAP, a private practice pediatrician in Scottsdale, Ariz., and infectious disease consultant in the Scottsdale-Phoenix area.
"Dosage [of the second-generation cephalosporin] was 30 mg/kg in two equally divided doses for 10 days." McLinn presented the findings in a poster at the First World Congress of Pediatric Infectious Diseases held in Acapulco, Mexico, recently. McLinn and his colleagues from 10 sites across the United States performed tympanocentesis before administering the drug to measure precisely its success rate. This rarely conducted procedure-it pinpoints bacteria found in middle ear fluidsshowed a total of 211 organisms from pretreatment cultures; and the two most common pathogens isolated were Streptococcus pneumoniae (44%) and Haemophilus influenzae (36%).
The study revealed significantly changing U.S. patterns of bacterial resistance, McLinn noted in an interview. "S. pneumoniae and H. influenzae were found in two-thirds of patients. Nearly half of the bacteria were difficult-to-treat strains."
Especially troubling was the fact that S. pneumoniae-resistant strains appeared in greater numbers than previously reported. The new study found a 46% resistance rate of pneumococcus in middle ear isolates compared with the 31% rate noted earlier by others. The investigation revealed organisms unresponsive not only to penicillin-type antibioticssuch as amoxicillin, the standard therapy for acute otitis media-but others that physicians usually turn to when penicillins fail.
Cefprozil performed with comparable clinical efficacy in eradicating resistant and nonresistant strains, McLinn noted. The incidence of adverse effects was low: diarrhea, 3%, and rash, 2%.
The young patients (median age: one year) were predominantly male (61 %) and white (65%). Many came from middle-class neighborhoods in towns and cities ranging from Whittier, Calif. …