TELI COM - Telithromycin in Children With Otitis Media

Multinational, Randomized, Double-Blind, Double-Dummy, Comparative Study to Evaluate the Efficacy and Safety of 5 Days Telithromycin 25mg/kg od Versus 5 Days Azithromycin 10 mg/kg od Followed by 5 mg/kg od for 4 Days, in Children With Acute Otitis Media

This is a multinational, randomized (1:1), double-blind, double-dummy, comparative, 2- treatmentgroup study in children (age range: ≥6 months and <72 months [< 6 years of age]) with AOM.Subjects will be randomized to receive either telithromycin (50 mg/mL) oral suspension 25 mg/kgonce daily for 5 days or azithromycin (40 mg/mL) oral suspension (10 mg/kg once on Day 1, followed by 5 mg/kg once daily on Days 2-5, not to exceed 500 mg onDay 1 and 250 mg/day from Days 2 - 5. Matching placebo suspensions for telithromycin and azithromycin will also be dispensed to provide blinding for the different treatment regimens.Assessments and reporting of safety will be carried out at all visits.

Study Overview

• Status: Terminated
• Conditions: Otitis Media, Suppurative; Otitis Media, Purulent
• Intervention / Treatment: Drug: Azithromycin; Drug: Telithromycin

• Study Type: Interventional
• Enrollment: 1500
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1642
    • Sanofi-Aventis
• Brazil
  • Sao Paulo, Brazil, 05677-000
    • Sanofi-Aventis
• Canada
  • Laval, Canada
    • Sanofi-Aventis
• Chile
  • Santiago
    • Providencia, Santiago, Chile
      • Sanofi-Aventis
• Colombia
  • Santafe de Bogota, Colombia
    • Sanofi-Aventis
• Costa Rica
  • San José, Costa Rica
    • Sanofi-Aventis
• Czech Republic
  • Praha, Czech Republic, 160 00
    • Sanofi-Aventis
• Dominican Republic
  • Santo-Domingo, Dominican Republic
    • Sanofi-Aventis
• Guatemala
  • Guatemala, Guatemala
    • Sanofi-Aventis
• Israel
  • Israel, Israel
    • Sanofi-Aventis
• Panama
  • Panama, Panama
    • Sanofi-Aventis
• Peru
  • Lima, Peru
    • Sanofi-Aventis
• United States
  • New Jersey
    • Bridgewater, New Jersey, United States, 08807
      • Sanofi-Aventis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Subjects meeting all of the following criteria will be considered for enrollment into the study:

• Subjects ≥6 months and <72 months (< 6 years) of age;
• Recent (within the last 72 hours) and rapid onset of AOM symptoms and signs;
• The presence of MEF on otoscopy indicated by a bulging tympanic membrane;
• Otalgia or ear tugging or touching within the last 24 hours that interferes with or precludes normal activity or sleep;
• At least 1 of the following clinical findings not specific to AOM: fever, vomiting, diarrhea, anorexia, sleep disturbance, or irritability;
• Caregiver-reported AOM symptoms sufficient for entry according to protocol criteria.
• Caregiver-reported AOM symptoms diary

• Tympanometry exhibiting:

  • Type B curve or positive pressure peak curves.

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the study:

• Uncertain diagnosis of AOM or mild to moderate symptoms and signs of AOM that would make the subject a candidate for observation and analgesic therapy with observation for 2-3 days.
• Otorrhea or tympanostomy tube present in the ear to be evaluated;
• Otitis externa;
• Down syndrome, cleft palate, craniofacial disorders, cystic fibrosis/mucoviscidosis, immotile cilia syndrome, congenital immunodeficiency or acquired immunodeficiency syndrome with <25% CD4 count or requiring prophylaxis for Pneumocystis jiroveci (carinii) or requiring treatment for an opportunistic infection;
• Known congenital long QT syndrome;
• Known or suspected uncorrected hypokalemia (≤3 mmol/L [mEq/L]), hypomagnesemia, bradycardia (<50 bpm);
• Myasthenia gravis;
• Known impaired renal function, as shown by creatinine clearance ≤25 mL/min;
• History of hypersensitivity or intolerance to macrolides or azithromycin;
• Previous enrollment in this study or previous treatment with telithromycin;
• Children of the investigator or subinvestigator, research assistant, pharmacist, study coordinator, other staff, or relative thereof directly involved in the conduct of the protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary efficacy variables will be time to symptom resolution (TSR) and clinical cure at theposttherapy/TOC Visit 3.

Secondary Outcome Measures

Outcome Measure
Adverse events (AEs) reported by subjects, their parents/legally authorized representative, orobserved by the investigators will be recorded throughout the study.

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): July 1, 2006
• Study Completion (Actual): July 1, 2006

Study Registration Dates

• First Submitted: April 13, 2006
• First Submitted That Met QC Criteria: April 14, 2006
• First Posted (Estimate): April 17, 2006

Study Record Updates

• Last Update Posted (Estimate): April 3, 2009
• Last Update Submitted That Met QC Criteria: April 2, 2009
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Keywords: Azithromycin; Otitis Media; Telithromycin; Suppurative; Purulent; Ketolide; Controlled Clinical Trials
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media; Suppuration; Otitis Media, Suppurative; Anti-Infective Agents; Anti-Bacterial Agents; Azithromycin; Telithromycin
• Other Study ID Numbers: EFC6132; HMR3647B/3002