Linked Life Data

9720470

Source:http://linkedlifedata.com/resource/pubmed/id/9720470

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
4
pubmed:dateCreated
1998-10-21
pubmed:abstractText
This trial compared the efficacy and safety of a 10-day treatment course of cefaclor and cefuroxime axetil in the treatment of acute otitis media with effusion in children who failed therapy with amoxicillin. This was an investigator-blind, randomized, parallel treatment group study. To be included, patients must have received treatment with a standard clinical regimen of amoxicillin for at least 48 hours and not more than 10 days, with the last dose within 72 hours of randomization. Patients who met the entry criteria were randomly assigned to one of two antibiotic treatment groups. Cefaclor and cefuroxime axetil suspensions were administered twice daily for a total daily dose of 40 mg/kg and 30 mg/kg, respectively. Physical examination, pneumatic otoscopy and tympanogram were performed to evaluate efficacy to therapy. Therapeutic equivalence was established by ruling out a difference (cefaclor minus cefuroxime axetil) of 15% in percentages of clinical success (cure plus improvement). Safety evaluation was performed by assessment of clinical adverse events. In the intent-to-treat analysis post-therapy (1-6 days after completion of therapy), 96 of 104 (92.3%) cefaclor-treated patients had clinical success compared to 90 of 101 (89.1%) cefuroxime axetil patients. The 95% confidence limits on the difference between proportions of favorable outcomes (cefaclor minus cefuroxime axetil) was from -4.8% to +11.2%. At termination of the study (day 10-16 after completion of therapy), 86 of 104 (82.7%) cefaclor patients and 84 of 101 (83.2%) cefuroxime axetil patients had favorable clinical outcomes (95% confidence interval: -10.8% to +9.9%). Thirty-two (30.8%) of the 104 patients in the cefaclor treatment group reported at least one adverse event, with rhinitis reported in 9 (8.7%) patients and cough increased in 7 (6.7%) patients. Thirty-six (35.6%) of the 101 patients in the cefuroxime axetil treatment group reported at least one event, with diarrhea reported in 11 (10.9%) of patients and rhinitis in 10 (9.9%) patients. Cefaclor and cefuroxime axetil were equally effective in the treatment of patients with acute otitis media with effusion who had failed therapy with amoxicillin. Significantly fewer patients treated with cefaclor reported diarrhea, which is the most frequently reported adverse event in children treated with antibiotics for this disease.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Aug
pubmed:issn
1120-009X
pubmed:author
pubmed:issnType
Print
pubmed:volume
10
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
306-12
pubmed:dateRevised
2009-8-4
pubmed:meshHeading
pubmed:year
1998
pubmed:articleTitle
Comparison of cefaclor and cefuroxime axetil in the treatment of acute otitis media with effusion in children who failed amoxicillin therapy.
pubmed:affiliation
Eli Lilly and Company, Indianapolis, IN 46285, USA.
pubmed:publicationType
Journal Article, Clinical Trial, Comparative Study, Randomized Controlled Trial