Abstract | BACKGROUND: Given the relatively high prevalence of recurrent and persistent acute otitis media (AOM) and the prominent etiologic role of Streptococcus pneumoniae, especially penicillin-nonsusceptible strains in children with these conditions, new alternative treatments are desirable. METHODS: Children 6 months-4 years of age with AOM considered to be at risk for recurrent or persistent infection received large dosage cefdinir 25 mg/kg oral suspension once daily for 10 days. Children were evaluated pretreatment (day 1), on therapy (days 4-6), end of therapy (days 12-14) and at follow-up (days 25-28). All children had tympanocentesis at enrollment. In culture-positive children, tympanocentesis was repeated after 3-5 days (days 4-6) unless evidence of absence of middle ear effusion was documented. RESULTS: Of 447 children enrolled, 230 were clinically and bacteriologically evaluable (74% 2 years old or younger; 57% treated for AOM in previous 3 months). Bacteriologic eradication, based on repeat tympanocentesis on days 4-6, was achieved in 74% (170 of 230) of children; 76% (201 of 266) of AOM pathogens were eradicated. Eradication of penicillin-susceptible, -intermediate and -resistant S. pneumoniae was 91% (50 of 55), 67% (18 of 27) and 43% (10 of 23), respectively (P < 0.001); eradication of H. influenzae was 72% (90 of 125). Overall clinical response at days 12-14 was 83% (76 and 82% for children with S. pneumoniae and Haemophilus influenzae, respectively). Sustained clinical response at days 25-28 was 85%. Clinical response was 83% for culture-positive children versus 96% for culture-negative children at baseline tympanocentesis (P < 0.001). CONCLUSIONS: In this study of AOM among children at risk for persistent or recurrent infection, large dose cefdinir resulted in an overall successful clinical response at end of treatment of 83%. This regimen was efficacious against penicillin-susceptible S. pneumoniae, but effectiveness was markedly decreased against nonsusceptible strains and was moderate for H. influenzae strains.
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Authors | Adriano Arguedas, Ron Dagan, Eugene Leibovitz, Alejandro Hoberman, Michael Pichichero, Maria Paris |
Journal | The Pediatric infectious disease journal
(Pediatr Infect Dis J)
Vol. 25
Issue 3
Pg. 211-8
(Mar 2006)
ISSN: 0891-3668 [Print] United States |
PMID | 16511382
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Infective Agents
- Cephalosporins
- Cefdinir
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Topics |
- Acute Disease
- Administration, Oral
- Anti-Infective Agents
(administration & dosage, adverse effects, therapeutic use)
- Cefdinir
- Cephalosporins
(administration & dosage, adverse effects, therapeutic use)
- Child, Preschool
- Female
- Humans
- Infant
- Male
- Microbial Sensitivity Tests
- Otitis Media with Effusion
(drug therapy, microbiology)
- Paracentesis
(methods)
- Penicillin Resistance
- Pneumococcal Infections
(drug therapy, microbiology)
- Recurrence
- Risk Factors
- Streptococcus pneumoniae
(drug effects)
- Treatment Outcome
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