Linked Life Data

8295814

Source:http://linkedlifedata.com/resource/pubmed/id/8295814

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
12 Suppl 3
pubmed:dateCreated
1994-3-3
pubmed:abstractText
The safety and efficacy of a new oral suspension formulation of clarithromycin were evaluated in this multicenter, Phase III, single blind, comparative trial in 379 children ages 6 months to 12 years with signs or symptoms of acute otitis media. Children were randomized to receive a 10-day course of clarithromycin oral suspension (7.5 mg/kg; maximum, 500 mg) or cefaclor oral suspension (20 mg/kg; maximum, 500 mg) twice daily. Specific clinical response criteria were developed based on pretreatment signs and symptoms and results of tympanometry. Of the 379 enrolled patients 281 (74%) were evaluable (clarithromycin, 150; cefaclor, 131). There were no demographic differences between the two groups. Fifty percent of the patients had 2 to 4 episodes of otitis media (including the current episode) in the past 12 months; 63% of the patients had an infection of moderate severity. Clarithromycin and cefaclor suspensions were similarly effective for the treatment of acute otitis media. Clinical success (cure, cure with effusion or improvement) was achieved in 86% of clarithromycin-treated patients and 90% of cefaclor-treated patients. The majority of bacterial isolates for which susceptibility results were available were fully or moderately susceptible to the study drugs (96% clarithromycin, 92% cefaclor). Both drugs were well-tolerated; adverse events considered probably study drug-related were reported by 30 (15%) of clarithromycin recipients and 31 (17%) of cefaclor recipients. There were no significant differences between the groups in the numbers of patients reporting events that were thought to be related to study medication.(ABSTRACT TRUNCATED AT 250 WORDS)
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Dec
pubmed:issn
0891-3668
pubmed:author
pubmed:issnType
Print
pubmed:volume
12
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
S128-33
pubmed:dateRevised
2006-11-15
pubmed:meshHeading
pubmed:year
1993
pubmed:articleTitle
Clarithromycin and cefaclor suspensions in the treatment of acute otitis media in children.
pubmed:affiliation
Department of Pathology, Primary Children's Medical Center, Salt Lake City, UT 84113.
pubmed:publicationType
Journal Article, Clinical Trial, Comparative Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Multicenter Study, Clinical Trial, Phase III