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.
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
- 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.