Abstract
An investigator-blinded, randomized, multicenter study was conducted to compare the efficacy and safety of cefdinir and amoxicillin/clavulanate (amoxicillin/CA) in the treatment of pediatric patients with acute suppurative otitis media. Patients 6 months to 12 years of age were randomized in a 1:1:1 ratio to receive cefdinir 14 mg/kg once-daily, cefdinir 7 mg/kg b.i.d., or amoxicillin/CA 13.3 mg/kg t.i.d. Test-of-cure was determined 11 to 16 days post therapy. Of the 752 patients who entered the study, 665 (88%) completed treatment and 595 (79%) were evaluable. Response rates in the three treatment groups were similar. Overall rates of adverse events were statistically lower in the cefdinir once-daily group than in the amoxicillin/CA group. Diarrhea was the most common adverse event in all treatment groups. Cefdinir given either once-daily or twice daily is a safe and effective treatment for pediatric patients with acute suppurative otitis media.
| Original language | English |
|---|---|
| Pages (from-to) | 214-219 |
| Number of pages | 6 |
| Journal | European Journal of Clinical Microbiology and Infectious Diseases |
| Volume | 16 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - Mar 1997 |
| Externally published | Yes |
Keywords
- otitis media
- children
