ARGUEDAS A, SHER L, LOPEZ E, SAEZ-LLORENS X, SKUBA K, PIERCE P; Interscience Conference on Antimicrobial Agents and Chemotherapy (41st : 2001 : Chicago, Ill.).
Abstr Intersci Conf Antimicrob Agents Chemother Intersci Conf Antimicrob Agents Chemother. 2001 Dec 16-19; 41: abstract no. G-1534.
Inst. Costarricense de Investigaciones Clin., San Jose, Costa Rica
BACKGROUND: GAT is a fluoroquinolone (FQ) with activity against the pathogens that cause RNR-AOM; because of an association between their use and the development of arthrotoxicity in juvenile animal models, these infections have not previously been treated with FQs. METHODS: Eligible children between 6 mos and 7 yrs of age were enrolled in an open-label study of GAT oral suspension given once daily as a 10 mg/kg dose for 10 d. Children were to have RNR-AOM, defined as 1) >/= 3 documented episodes of otitis media in the last 6 mos or >/= 4 documented episodes in the last 12 mos or 2) failure of therapy for AOM within 14 d of enrollment. Tympanocentesis was mandatory unless middle ear fluid (MEF) was available via a new perforation. Response to therapy was assessed at a test of cure (TOC) visit 4 to 7 d after the last dose of GAT. A patient was considered a cure if pain and bulging of the tympanic membrane had resolved, and no further antibiotics for otitis had been prescribed. RESULTS: Data are available for 223 of the 254 children enrolled. Forty-seven percent (104/223) had recurrent otitis, 30% (68/223) were treatment failures, and 18% (41/223) had both diagnoses. Pathogens isolated in MEF included 42 S. pneumoniae (SPn), including 4 fully penicillin resistant isolates; 38 H. influenzae; and 9 M. catarrhalis. The cure rate in the evaluable population at TOC was 87% (150/173); among evaluable patients with SPn, the cure rate was 91% (30/33). The most frequent drug-related adverse events were vomiting (15%) and diarrhea (5%). There have been no reports of arthropathy. CONCLUSION: Preliminaryresults suggest that GAT, given as 10mg/kg for 10 d, is safe and effective for the treatment of RNR-AOM.
Publication Types:
Keywords:
- Acute Disease
- Anti-Bacterial Agents
- Child
- Fluoroquinolones
- GAT
- Haemophilus influenzae
- Humans
- Otitis Media
- Penicillins
- Peptides
- Recurrence
- Treatment Failure
- gatifloxacin
- therapy
Other ID:
UI: 102270139
From Meeting Abstracts