HAMED KA, SHER L, ARGUEDAS A, HUSSEMAN M, BISWAS D, PIERCE P, ECHOLS R; Interscience Conference on Antimicrobial Agents and Chemotherapy (43rd: 2003: Chicago, Ill.).
Abstr Intersci Conf Antimicrob Agents Chemother Intersci Conf Antimicrob Agents Chemother. 2003 Sep 14-17; 43: abstract no. G-1850.
Bristol-Myers Squibb, Wallingford, CT.
BACKGROUND: A randomized controlled study assessing the efficacy and safety of a quinolone antibiotic in the treatment of children with recurrent otitis media (ROM) or acute otitis media treatment failures (OMTF) has not been reported previously. Decreased susceptibility to commonly used antibiotics necessitates consideration of new options for these patients. Gatifloxacin oral suspension (GAT) was compared to the standard of care, high-dose amoxicillin/clavulanate (HDA), in ROM and/or OMTF. METHODS: This prospective, randomized, investigator-blinded, multicenter (mainly US) study enrolled children aged 6 months to 7 years with ROM (>/= 3 episodes in 6 months or >/= 4 episodes in 12 months) or OMTF (current episode within 14 days of last dose of prior antibiotic treatment). Patients were randomized to receive GAT 10 mg/kg QD or HDA 90/6.4 mg/kg/day divided BID, each PO for 10 days. Clinical response at the test-of-cure visit (TOC) 3-10 days post-therapy was the primary efficacy measure. RESULTS: Of 349 treated patients, 240 were clinically evaluable (124 GAT, 116 HDA). The treatment groups were well balanced with respect to demographics and infection characteristics. Overall, the median age was 2 years and 59% had OMTF +/- ROM. Clinical cure rates at the TOC were 85% (105/124) for GAT- and 78% (91/116) for HDA-treated patients [95% CI for difference: (-2.7%, 16.6%)]. Arthralgia was reported in 0.6% (1/176) of GAT vs 1.2% (2/173) of HDA. No arthrotoxicity was identified up to at least 6 months post-therapy. Rates of drug-related adverse events were similar overall for GAT (24%) and HDA (27%). CONCLUSIONS: GAT was as safe and effective as HDA in the treatment of children with ROM and/or OMTF. Treatment with GAT represents an important new class alternative to HDA for difficult to treat cases of otitis media.
Publication Types:
Keywords:
- Acute Disease
- Amoxicillin
- Anti-Bacterial Agents
- Child
- Clavulanic Acid
- Fluoroquinolones
- Humans
- Longitudinal Studies
- Otitis Media
- Recurrence
- Treatment Failure
- administration & dosage
- gatifloxacin
Other ID:
UI: 102265774
From Meeting Abstracts