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A multicenter, open label, double tympanocentesis study of high dose cefdinir in children with acute otitis media at high risk of persistent or recurrent infection.
Pediatr Infect Dis J 2006; 25(3):211-8PI

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.

Authors+Show Affiliations

Instituto de Atención Pediátrica, Neeman-ICIC, Hospital Nacional de Niños, San José, Costa Rica. aarguedas@iped.netNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16511382

Citation

Arguedas, Adriano, et al. "A Multicenter, Open Label, Double Tympanocentesis Study of High Dose Cefdinir in Children With Acute Otitis Media at High Risk of Persistent or Recurrent Infection." The Pediatric Infectious Disease Journal, vol. 25, no. 3, 2006, pp. 211-8.
Arguedas A, Dagan R, Leibovitz E, et al. A multicenter, open label, double tympanocentesis study of high dose cefdinir in children with acute otitis media at high risk of persistent or recurrent infection. Pediatr Infect Dis J. 2006;25(3):211-8.
Arguedas, A., Dagan, R., Leibovitz, E., Hoberman, A., Pichichero, M., & Paris, M. (2006). A multicenter, open label, double tympanocentesis study of high dose cefdinir in children with acute otitis media at high risk of persistent or recurrent infection. The Pediatric Infectious Disease Journal, 25(3), pp. 211-8.
Arguedas A, et al. A Multicenter, Open Label, Double Tympanocentesis Study of High Dose Cefdinir in Children With Acute Otitis Media at High Risk of Persistent or Recurrent Infection. Pediatr Infect Dis J. 2006;25(3):211-8. PubMed PMID: 16511382.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A multicenter, open label, double tympanocentesis study of high dose cefdinir in children with acute otitis media at high risk of persistent or recurrent infection. AU - Arguedas,Adriano, AU - Dagan,Ron, AU - Leibovitz,Eugene, AU - Hoberman,Alejandro, AU - Pichichero,Michael, AU - Paris,Maria, PY - 2006/3/3/pubmed PY - 2006/5/11/medline PY - 2006/3/3/entrez SP - 211 EP - 8 JF - The Pediatric infectious disease journal JO - Pediatr. Infect. Dis. J. VL - 25 IS - 3 N2 - 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. SN - 0891-3668 UR - https://www.unboundmedicine.com/medline/citation/16511382/A_multicenter_open_label_double_tympanocentesis_study_of_high_dose_cefdinir_in_children_with_acute_otitis_media_at_high_risk_of_persistent_or_recurrent_infection_ L2 - http://Insights.ovid.com/pubmed?pmid=16511382 DB - PRIME DP - Unbound Medicine ER -