NCT00638534

Brief Summary

The primary objective is to assess the safety of telithromycin (HMR3647) 20 mg/kg qd for 5 days in children with acute otitis media (AOM). Secondary objectives are to assess Efficacy, Pharmacokinetics and Acceptability of telithromycin 20 mg/kg qd for 5 days in children with AOM.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2004

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2008

Completed
Last Updated

October 2, 2009

Status Verified

October 1, 2009

Enrollment Period

8 months

First QC Date

March 12, 2008

Last Update Submit

October 1, 2009

Conditions

Otitis Media

Keywords

Acute Otitis MediaAOMchildrenChild

Outcome Measures

Primary Outcomes (1)

  • Safety evaluation: presence/absence of subjective/objective symptoms and abnormal laboratory findings

Secondary Outcomes (3)

  • Clinical efficacy: tympanic signs

  • Acceptability: compliance and willingness to take medication

  • Pharmacokinetics: plasma concentrations of telithromycin

Interventions

Telithromycin (HMR3647)DRUG

Eligibility Criteria

Age6 Months - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Subjects who are weighing 40 kg or less. If female, premenarchal status is required.
  • Subjects with signs of infection according to middle ear signs and general signs or symptoms such as otalgia, fever, sleep disturbance, irritability, inconsolability.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Tokyo, Japan

Location

MeSH Terms

Conditions

Otitis Media

Interventions

telithromycin

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • CSD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 12, 2008

First Posted

March 19, 2008

Study Start

February 1, 2004

Primary Completion

October 1, 2004

Study Completion

October 1, 2004

Last Updated

October 2, 2009

Record last verified: 2009-10

Locations

JP(1)