Terminated PHASE3 INTERVENTIONAL NCT00174811

Comparative Study to Evaluate the Efficacy and Safety of Telithromycin Given Once Daily Versus Cefuroxime Axetil Given Twice Daily in Children With Middle Ear Infections

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

Sponsor: Sanofi

Conditions Otitis Media

Interventions telithromycin (HMR3647)

Updated 5 times since 2017 Last updated: Apr 2, 2009 Started: Jun 30, 2005 Primary completion: Jun 30, 2006 Completion: Jun 30, 2006

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Pediatric development program terminated by sponsor

A PHASE3 clinical study on Otitis Media, this trial is terminated or withdrawn. The trial is conducted by Sanofi and has accumulated 5 data snapshots since 2005. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

5 versions recorded

Sep 2024 — Present [monthly]

Terminated PHASE3
Jul 2024 — Sep 2024 [monthly]

Terminated PHASE3
Jan 2021 — Jul 2024 [monthly]

Terminated PHASE3
Jun 2018 — Jan 2021 [monthly]

Terminated PHASE3
Jan 2017 — Jun 2018 [monthly]

Terminated PHASE3

First recorded

Jun 2005

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Sanofi

Data source: Sanofi

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Bridgewater, United States
• Paris, France