To determine the efficacy and safety of different doses of faropenem medoxomil in acute otitis media as measured by double tympanocentesis

Abstract number: R2534

Arguedas A., Dagan R., Leibovitz E., Wang E., Song J., Critchley I., Tosiello R., Echols R.

Objectives: to determine the efficacy and saftey of 4 doses of FM in AOM and the impact of therapy on colonisation and antimicrobial resistance development in children aged 6 months – 7 years.

Methods: Subjects with AOM were enrolled in 2 sites, Costa Rica & Israel and randomised to receive one of following doses of FM in cohort 1: 7.5 and 15 mg/kg/dose and in cohort 2: 15, 30 or 40 mg/kg/dose bid for 10 days. Baseline tympanocentesis taken on all subjects and repeated on day 4–6 in those with positive baseline or those who had clinically failed. Test of cure clinical response was evaluated at d 12–14 and late follow up at d 28–32. Naso-oropharyngeal swabs were taken at each visit.

Results: Total of 328 subjects enrolled leading to 47(7.5); 77(15), 79(30) and 67(40) [total 270] who completed 10 days therapy (82%). 92% of patients were enrolled in Costa Rica, 56.9% <2 years old, 28.2% had received antibiotics in preceding 30 days. Pathogens isolated were S. pneumoniae 113 (44.0%), H. influenzae 103 (40.2%), M. catarrhalis 28 (10.9%) & S. pyogenes 12 (5.9%), total 256. Significant dose effect on bacteriologic eradication. However, higher eradication seen in cohort 2 of 15 mg/kg group (85% vs. 62.5%, p = 0.07), suggesting cohort effect may be confounding. Eradication of H. influenzae accounted for dose effect and significantly higher even within cohort 1 (15 mg vs. 7.5 mg, p = 0.01).

No FM resistance emergence. Reduction in oral or nasal colonisation was observed for S. pneumoniae and M. catarrhalis.

Conclusions: FM was efficacious and well tolerated at doses of at least 15 mg/kg/dose given bid for 10 days in AOM.

Session Details

Date: 19/04/2008
Time: 00:00-00:00
Session name: 18th European Congress of Clinical Microbiology and Infectious Diseases
Location: Barcelona, Spain
Presentation type:
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