Tags

Type your tag names separated by a space and hit enter

Comparison of five-day cefdinir treatment with ten-day low dose amoxicillin/clavulanate treatment for acute otitis media.
Pediatr Infect Dis J 2004; 23(9):834-8PI

Abstract

BACKGROUND

Short course beta-lactam antibiotic therapy for acute otitis media (AOM) should improve patient adherence, but it has not been evaluated since the heptavalent pneumococcal conjugate vaccine became routinely used in the United States.

METHODS

In a prospective, investigator-blinded, multicenter study, 425 patients, age 6 months-6 years, with a clinical diagnosis of nonrefractory AOM were randomized to receive either 5 days of cefdinir therapy (14 mg/kg divided twice daily) or 10 days of amoxicillin/clavulanate therapy (45/6.4 mg/kg divided twice daily). Clinical response was assessed at end of therapy (2-4 days postantibiotic, respectively) and week 4 (study days 25-28).

RESULTS

With no difference in demographics between treatment groups, overall the mean age (+/-SD) was 2.8 +/- 1.8 years, 65% had received conjugated pneumococcal vaccination and 48% had bilateral AOM. The satisfactory clinical response rate at end of therapy was comparable for cefdinir versus amoxicillin/clavulanate (88%, 170 of 194 versus 85%, 164 of 192; 95% CI -4.9, 9.3). Although this must be interpreted with caution, cefdinir showed an apparent trend for higher efficacy than amoxicillin/clavulanate (92%, 72 of 78 versus 77%, 55 of 71; P = 0.019) in a subsample of patients 6-24 months old who had received conjugated pneumococcal vaccination. The incidence of drug-related adverse events was less for cefdinir than for amoxicillin/clavulanate (24%, 50 of 211 versus 38%, 82 of 214; P = 0.0018)

CONCLUSION

For children with nonrefractory AOM, based only on clinical endpoints, 5 days of therapy with cefdinir 14 mg/kg divided twice daily was comparable overall with 10 days of therapy with low dose amoxicillin/clavulanate 45/6.4 mg/kg divided twice daily.

Authors+Show Affiliations

Kentucky Pediatric/Adult Research, Bardstown, KY, USA. sblock@pol.netNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

15361722

Citation

Block, Stan L., et al. "Comparison of Five-day Cefdinir Treatment With Ten-day Low Dose Amoxicillin/clavulanate Treatment for Acute Otitis Media." The Pediatric Infectious Disease Journal, vol. 23, no. 9, 2004, pp. 834-8.
Block SL, Busman TA, Paris MM, et al. Comparison of five-day cefdinir treatment with ten-day low dose amoxicillin/clavulanate treatment for acute otitis media. Pediatr Infect Dis J. 2004;23(9):834-8.
Block, S. L., Busman, T. A., Paris, M. M., & Bukofzer, S. (2004). Comparison of five-day cefdinir treatment with ten-day low dose amoxicillin/clavulanate treatment for acute otitis media. The Pediatric Infectious Disease Journal, 23(9), pp. 834-8.
Block SL, et al. Comparison of Five-day Cefdinir Treatment With Ten-day Low Dose Amoxicillin/clavulanate Treatment for Acute Otitis Media. Pediatr Infect Dis J. 2004;23(9):834-8. PubMed PMID: 15361722.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of five-day cefdinir treatment with ten-day low dose amoxicillin/clavulanate treatment for acute otitis media. AU - Block,Stan L, AU - Busman,Todd A, AU - Paris,Maria M, AU - Bukofzer,Stanley, PY - 2004/9/14/pubmed PY - 2004/10/29/medline PY - 2004/9/14/entrez SP - 834 EP - 8 JF - The Pediatric infectious disease journal JO - Pediatr. Infect. Dis. J. VL - 23 IS - 9 N2 - BACKGROUND: Short course beta-lactam antibiotic therapy for acute otitis media (AOM) should improve patient adherence, but it has not been evaluated since the heptavalent pneumococcal conjugate vaccine became routinely used in the United States. METHODS: In a prospective, investigator-blinded, multicenter study, 425 patients, age 6 months-6 years, with a clinical diagnosis of nonrefractory AOM were randomized to receive either 5 days of cefdinir therapy (14 mg/kg divided twice daily) or 10 days of amoxicillin/clavulanate therapy (45/6.4 mg/kg divided twice daily). Clinical response was assessed at end of therapy (2-4 days postantibiotic, respectively) and week 4 (study days 25-28). RESULTS: With no difference in demographics between treatment groups, overall the mean age (+/-SD) was 2.8 +/- 1.8 years, 65% had received conjugated pneumococcal vaccination and 48% had bilateral AOM. The satisfactory clinical response rate at end of therapy was comparable for cefdinir versus amoxicillin/clavulanate (88%, 170 of 194 versus 85%, 164 of 192; 95% CI -4.9, 9.3). Although this must be interpreted with caution, cefdinir showed an apparent trend for higher efficacy than amoxicillin/clavulanate (92%, 72 of 78 versus 77%, 55 of 71; P = 0.019) in a subsample of patients 6-24 months old who had received conjugated pneumococcal vaccination. The incidence of drug-related adverse events was less for cefdinir than for amoxicillin/clavulanate (24%, 50 of 211 versus 38%, 82 of 214; P = 0.0018) CONCLUSION: For children with nonrefractory AOM, based only on clinical endpoints, 5 days of therapy with cefdinir 14 mg/kg divided twice daily was comparable overall with 10 days of therapy with low dose amoxicillin/clavulanate 45/6.4 mg/kg divided twice daily. SN - 0891-3668 UR - https://www.unboundmedicine.com/medline/citation/15361722/Comparison_of_five_day_cefdinir_treatment_with_ten_day_low_dose_amoxicillin/clavulanate_treatment_for_acute_otitis_media_ L2 - http://Insights.ovid.com/pubmed?pmid=15361722 DB - PRIME DP - Unbound Medicine ER -