Multinational, Randomized, Double-Blind, Double-Dummy, Comparative Study to Evaluate the Efficacy and Safety of Telithromycin 25 mg/kg Given Once Daily for 5 or 10 Days Depending on Age and Previous Treatment History Versus Cefuroxime Axetil 15 mg/kg, Given Twice Daily for 10 Days, in Children With Acute Otitis Media.

Trial Profile

Multinational, Randomized, Double-Blind, Double-Dummy, Comparative Study to Evaluate the Efficacy and Safety of Telithromycin 25 mg/kg Given Once Daily for 5 or 10 Days Depending on Age and Previous Treatment History Versus Cefuroxime Axetil 15 mg/kg, Given Twice Daily for 10 Days, in Children With Acute Otitis Media.

Discontinued
Phase of Trial: Phase III

Latest Information Update: 21 Jul 2011

At a glance

  • Drugs Cefuroxime axetil; Telithromycin
  • Indications Bacterial infections; Otitis media
  • Focus Therapeutic Use
  • Sponsors Sanofi
  • Most Recent Events

    • 08 Apr 2009 Planned end date (1 Jun 2006) added as reported by ClinicalTrials.gov.
    • 08 Apr 2009 Planned number of patients changed from 900 to 639 as reported by ClinicalTrials.gov.
    • 07 Mar 2008 Status changed from suspended to discontinued.
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