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Comparative United States and European trials of loracarbef in the treatment of acute otitis media.
Pediatr Infect Dis J. 1992 Aug; 11(8 Suppl):S12-9.PI

Abstract

Acute otitis media with effusion is one of the most common infectious diseases of childhood. Two multicenter randomized controlled clinical trials were conducted to assess the relative safety and efficacy of loracarbef and either amoxicillin/clavulanate or amoxicillin in the treatment of acute otitis media. Patients were evaluated clinically and bacteriologically at a pretherapy visit (within 48 hours of study drug administration), a posttherapy visit (within 72 hours after completion of therapy), and a late posttherapy visit (10 to 16 days after completion of therapy). In both studies, etiologic agents were assessed by tympanocentesis. In both studies patients had to have a pathogen susceptible to both study drugs to be continued in the study and declared evaluable. The first study, conducted at 24 United States centers, compared loracarbef 30 mg/kg/day in two divided doses and amoxicillin/clavulanate 40 mg/kg/day in three divided doses each for 10 days. At the posttherapy visit 124 (87.3%) of 142 evaluable loracarbef-treated patients and 130 (91.5%) of 142 evaluable amoxicillin/clavulanate-treated patients had favorable (cure or improvement) clinical outcomes (P = 0.247). Loracarbef-treated patients were significantly less likely to experience adverse events, notably diarrhea, than amoxicillin/clavulanate-treated patients (P less than 0.001). The second study, conducted at 12 European sites, compared loracarbef 30 mg/kg/day in two divided doses and amoxicillin 40 mg/kg/day in three divided doses each for 7 days. At the posttherapy visit 120 (81.1%) of 148 evaluable loracarbef-treated patients and 125 (87.4%) of 143 amoxicillin-treated patients had favorable clinical outcomes (P = 0.139). Loracarbef and amoxicillin displayed comparable safety, although vomiting appeared more frequently among patients receiving amoxicillin (P = 0.011).(

ABSTRACT

TRUNCATED AT 250 WORDS)

Authors+Show Affiliations

Medical College of Georgia, Augusta.No affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial
Review

Language

eng

PubMed ID

1513607

Citation

Foshee, W S., and Y Qvarnberg. "Comparative United States and European Trials of Loracarbef in the Treatment of Acute Otitis Media." The Pediatric Infectious Disease Journal, vol. 11, no. 8 Suppl, 1992, pp. S12-9.
Foshee WS, Qvarnberg Y. Comparative United States and European trials of loracarbef in the treatment of acute otitis media. Pediatr Infect Dis J. 1992;11(8 Suppl):S12-9.
Foshee, W. S., & Qvarnberg, Y. (1992). Comparative United States and European trials of loracarbef in the treatment of acute otitis media. The Pediatric Infectious Disease Journal, 11(8 Suppl), S12-9.
Foshee WS, Qvarnberg Y. Comparative United States and European Trials of Loracarbef in the Treatment of Acute Otitis Media. Pediatr Infect Dis J. 1992;11(8 Suppl):S12-9. PubMed PMID: 1513607.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparative United States and European trials of loracarbef in the treatment of acute otitis media. AU - Foshee,W S, AU - Qvarnberg,Y, PY - 1992/8/1/pubmed PY - 1992/8/1/medline PY - 1992/8/1/entrez SP - S12 EP - 9 JF - The Pediatric infectious disease journal JO - Pediatr Infect Dis J VL - 11 IS - 8 Suppl N2 - Acute otitis media with effusion is one of the most common infectious diseases of childhood. Two multicenter randomized controlled clinical trials were conducted to assess the relative safety and efficacy of loracarbef and either amoxicillin/clavulanate or amoxicillin in the treatment of acute otitis media. Patients were evaluated clinically and bacteriologically at a pretherapy visit (within 48 hours of study drug administration), a posttherapy visit (within 72 hours after completion of therapy), and a late posttherapy visit (10 to 16 days after completion of therapy). In both studies, etiologic agents were assessed by tympanocentesis. In both studies patients had to have a pathogen susceptible to both study drugs to be continued in the study and declared evaluable. The first study, conducted at 24 United States centers, compared loracarbef 30 mg/kg/day in two divided doses and amoxicillin/clavulanate 40 mg/kg/day in three divided doses each for 10 days. At the posttherapy visit 124 (87.3%) of 142 evaluable loracarbef-treated patients and 130 (91.5%) of 142 evaluable amoxicillin/clavulanate-treated patients had favorable (cure or improvement) clinical outcomes (P = 0.247). Loracarbef-treated patients were significantly less likely to experience adverse events, notably diarrhea, than amoxicillin/clavulanate-treated patients (P less than 0.001). The second study, conducted at 12 European sites, compared loracarbef 30 mg/kg/day in two divided doses and amoxicillin 40 mg/kg/day in three divided doses each for 7 days. At the posttherapy visit 120 (81.1%) of 148 evaluable loracarbef-treated patients and 125 (87.4%) of 143 amoxicillin-treated patients had favorable clinical outcomes (P = 0.139). Loracarbef and amoxicillin displayed comparable safety, although vomiting appeared more frequently among patients receiving amoxicillin (P = 0.011).(ABSTRACT TRUNCATED AT 250 WORDS) SN - 0891-3668 UR - https://www.unboundmedicine.com/medline/citation/1513607/Comparative_United_States_and_European_trials_of_loracarbef_in_the_treatment_of_acute_otitis_media_ L2 - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=linkout&SEARCH=1513607.ui DB - PRIME DP - Unbound Medicine ER -