GUGGENBICHLER JP, BOREK M, RIDL W; Interscience Conference on Antimicrobial Agents and Chemotherapy.
Abstr Intersci Conf Antimicrob Agents Chemother Intersci Conf Antimicrob Agents Chemother. 2000 Sep 17-20; 40: 467.
Univ. of Erlangen, D-91054 Erlangen, Germany
Objective: To verify clinically the pharmacodynamic rationale supporting a twice daily administration of amoxicillin.METHODS: 516 patients (mean age 4 +/- 2.6 years) with clinical and otoscopic diagnosis of AOM were included in a randomized, double blind, multicentre study, and were treated 10 days either with AMOX 30 mg/kg bid or AMOX 15 mg/kg tid. AOM was defined as middle ear effusion associated with at least moderate or severe tympanic membrane inflammation, with at least one specific and at least one non-specific signs/symptoms. Assessments were made during therapy (day 3-5), after End of Therapy (EOT, day 12-14) and Follow Up (FU, day 38-46). The primary efficacy endpoint was the clinical response at EOT defined as success (cure/improvement) or failure. Secondary efficacy endpoint was the clinical response at FU defined as recurrence or success [table: see text]. 515 patients were evaluable for safety analysis. Both regimens were well tolerated; one or more drug-related adverse events (AEs) were reported in 14.3% (37/259) of bid patients and in 11.7% (30/256) of tid patients. The most frequently reported drug-related AEs in each group were gastrointestinal symptoms (bid 11.3 % vs. tid 9.8 %), which were mainly of mild or moderate severity. Conclusion: This trial shows that both dosage regimens were clinically equivalent in the treatment of AOM.KEYWORDS: Amoxicillin; Bid; Otitis
Publication Types:
Keywords:
- Acute Disease
- Amoxicillin
- Child
- Drug Tolerance
- Humans
- Otitis Media
- Otitis Media with Effusion
- Recurrence
- Treatment Outcome
- therapy
Other ID:
UI: 102248406
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