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Japanese Study Evaluating Safety, Efficacy and Acceptability of Telithromycin in Children With Infections

NCT00408135 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2009-04-03

No results posted yet for this study

Summary

The primary objective is to assess the safety of telithromycin (HMR 3647) (20% fine granules) 1g filling sachet in children with infections (Respiratory tract infections, Dermatological infections, Otorhinolaryngological infections, Dentistry/Oral surgery infections).

Secondary objectives are to assess the clinical efficacy, bacteriological efficacy and acceptability of telithromycin (20% fine granules) 1g filling sachet in children with infections.

Conditions

Interventions

DRUG

telithromycin (HMR3647)

Sponsors & Collaborators

Principal Investigators

  • Norifumi Yamamoto · sanofi-aventis Japan

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-08-31
Primary Completion
2005-05-31
Completion
2005-05-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00408135 on ClinicalTrials.gov