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A randomized comparative study of levofloxacin versus amoxicillin/clavulanate for treatment of infants and young children with recurrent or persistent acute otitis media.
Pediatr Infect Dis J 2008; 27(6):483-9PI

Abstract

BACKGROUND

The need for alternative antimicrobial therapy for recurrent and persistent acute otitis media (AOM) in children has raised interest in assessing the efficacy and safety of fluoroquinolones for treatment of these infections.

METHODS

In an evaluator-blinded, active-comparator, noninferiority, multicenter study, children (6 months to <5 years) were randomized 1:1 to receive levofloxacin (10 mg/kg twice daily) or amoxicillin/clavulanate (14:1; amoxicillin 45 mg/kg twice daily) for 10 days, with evaluations 4-6 days of therapy (visit 2), 2-5 days after completing therapy (visit 3), and 10-17 days after last dose (visit 4). Primary outcome was clinical cure at visit 3 based on resolution of clinical signs and symptoms of AOM.

RESULTS

A total of 1650 children were randomized and 1305 were clinically evaluable at visit 3 (630 levofloxacin, 675 comparator). Clinical cure rates were 72.4% (456 of 630) in levofloxacin-treated and 69.9% (472 of 675) in amoxicillin/clavulanate-treated children. Cure rates were also similar for levofloxacin and comparator for each age group (< or =24 months: 68.9% versus 66.2%; >24 months: 76.9% versus 75.1%; respectively). Cure rates at visit 4 were 74.9% and 73.8% in levofloxacin and amoxicillin/clavulanate groups, respectively. The upper limits of the confidence intervals were less than the noninferiority margin of 10% indicating that levofloxacin treatment is noninferior to comparator treatment overall and in both infants (6 months to 2 years) and children 2-5 years. No differences between treatment groups regarding the frequency or type of adverse events were apparent.

CONCLUSIONS

Levofloxacin was not inferior to amoxicillin/clavulanate for the treatment of recurrent and/or persistent AOM in infants and children.

Authors+Show Affiliations

Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ 08869, USA. gnoel1@prdus.jnj.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

18449063

Citation

Noel, Gary J., et al. "A Randomized Comparative Study of Levofloxacin Versus Amoxicillin/clavulanate for Treatment of Infants and Young Children With Recurrent or Persistent Acute Otitis Media." The Pediatric Infectious Disease Journal, vol. 27, no. 6, 2008, pp. 483-9.
Noel GJ, Blumer JL, Pichichero ME, et al. A randomized comparative study of levofloxacin versus amoxicillin/clavulanate for treatment of infants and young children with recurrent or persistent acute otitis media. Pediatr Infect Dis J. 2008;27(6):483-9.
Noel, G. J., Blumer, J. L., Pichichero, M. E., Hedrick, J. A., Schwartz, R. H., Balis, D. A., ... Arguedas, A. (2008). A randomized comparative study of levofloxacin versus amoxicillin/clavulanate for treatment of infants and young children with recurrent or persistent acute otitis media. The Pediatric Infectious Disease Journal, 27(6), pp. 483-9. doi:10.1097/INF.0b013e318168d2cb.
Noel GJ, et al. A Randomized Comparative Study of Levofloxacin Versus Amoxicillin/clavulanate for Treatment of Infants and Young Children With Recurrent or Persistent Acute Otitis Media. Pediatr Infect Dis J. 2008;27(6):483-9. PubMed PMID: 18449063.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized comparative study of levofloxacin versus amoxicillin/clavulanate for treatment of infants and young children with recurrent or persistent acute otitis media. AU - Noel,Gary J, AU - Blumer,Jeffrey L, AU - Pichichero,Michael E, AU - Hedrick,James A, AU - Schwartz,Richard H, AU - Balis,Dainius A, AU - Melkote,Rama, AU - Bagchi,Partha, AU - Arguedas,Adriano, PY - 2008/5/2/pubmed PY - 2008/7/4/medline PY - 2008/5/2/entrez SP - 483 EP - 9 JF - The Pediatric infectious disease journal JO - Pediatr. Infect. Dis. J. VL - 27 IS - 6 N2 - BACKGROUND: The need for alternative antimicrobial therapy for recurrent and persistent acute otitis media (AOM) in children has raised interest in assessing the efficacy and safety of fluoroquinolones for treatment of these infections. METHODS: In an evaluator-blinded, active-comparator, noninferiority, multicenter study, children (6 months to <5 years) were randomized 1:1 to receive levofloxacin (10 mg/kg twice daily) or amoxicillin/clavulanate (14:1; amoxicillin 45 mg/kg twice daily) for 10 days, with evaluations 4-6 days of therapy (visit 2), 2-5 days after completing therapy (visit 3), and 10-17 days after last dose (visit 4). Primary outcome was clinical cure at visit 3 based on resolution of clinical signs and symptoms of AOM. RESULTS: A total of 1650 children were randomized and 1305 were clinically evaluable at visit 3 (630 levofloxacin, 675 comparator). Clinical cure rates were 72.4% (456 of 630) in levofloxacin-treated and 69.9% (472 of 675) in amoxicillin/clavulanate-treated children. Cure rates were also similar for levofloxacin and comparator for each age group (< or =24 months: 68.9% versus 66.2%; >24 months: 76.9% versus 75.1%; respectively). Cure rates at visit 4 were 74.9% and 73.8% in levofloxacin and amoxicillin/clavulanate groups, respectively. The upper limits of the confidence intervals were less than the noninferiority margin of 10% indicating that levofloxacin treatment is noninferior to comparator treatment overall and in both infants (6 months to 2 years) and children 2-5 years. No differences between treatment groups regarding the frequency or type of adverse events were apparent. CONCLUSIONS: Levofloxacin was not inferior to amoxicillin/clavulanate for the treatment of recurrent and/or persistent AOM in infants and children. SN - 0891-3668 UR - https://www.unboundmedicine.com/medline/citation/18449063/A_randomized_comparative_study_of_levofloxacin_versus_amoxicillin/clavulanate_for_treatment_of_infants_and_young_children_with_recurrent_or_persistent_acute_otitis_media_ L2 - http://Insights.ovid.com/pubmed?pmid=18449063 DB - PRIME DP - Unbound Medicine ER -