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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Child; Infections

Treatments: Drug: telithromycin (HMR3647)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00408135

HMR3647B/3104

EFC6371

Details and patient eligibility

About

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.

Enrollment: 111 patients

Sex: All

Ages: 6 months to 16 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Outpatients of weight from 7.0 kg.
• For respiratory tract infections:subjects diagnosed with mild or moderate respiratory tract infection (excluding pneumonia) based on a fever (≥ 38°C) or C-Reactive Protein positive, clinical symptoms/signs, and laboratory findings.
• For dermatological infections: subjects diagnosed with mild or moderate dermatological infection in terms of clinical symptoms/signs and laboratory findings.
• For otorhinolaryngological infections:subjects with purulent / mucopurulent rhinorrhea and postrhinorrhea, subjects diagnosed with mild or moderate otorhinolaryngological infection in terms of clinical symptoms/signs and laboratory findings
• For dental / oral surgical infections: subjects who have formed obstructive abscess and diagnosed with mild or moderate dental / oral surgical infection

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)