TELI COM - Telithromycin in Children With Otitis Media

NCT00315003 | Terminated Phase 3

• 2 other identifiers: EFC6132HMR3647B/3002
• Study Type: interventional
• Target: 1,500
• Locations: 12 countries
• Sites: 12

Brief Summary

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.

Conditions

Otitis Media, Suppurative; Otitis Media, Purulent

Keywords

Otitis Media; Suppurative; Purulent; Ketolide; Azithromycin; Telithromycin; Controlled Clinical Trials

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

Telithromycin DRUG

Azithromycin DRUG

Eligibility Criteria

• Age: 6 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (13)

Sanofi-Aventis

Bridgewater, New Jersey, 08807, United States

Location

Sanofi-Aventis

Buenos Aires, 1642, Argentina

Location

Sanofi-Aventis

São Paulo, 05677-000, Brazil

Location

Sanofi-Aventis

Laval, Canada

Location

Sanofi-Aventis

Providencia, Santiago Metropolitan, Chile

Location

Sanofi-Aventis

Bogotá, Colombia

Location

Sanofi-Aventis

San José, Costa Rica

Location

Sanofi-Aventis

Prague, 160 00, Czechia

Location

Sanofi-Aventis

Santo Domingo, Dominican Republic

Location

Sanofi-Aventis

Guatemala City, Guatemala

Location

Sanofi-Aventis

Israel, Israel

Location

Sanofi-Aventis

Panama City, Panama

Location

Sanofi-Aventis

Lima, Peru

Location

MeSH Terms

Conditions

Otitis Media, Suppurative; Otitis Media; Suppuration

Interventions

telithromycin; Azithromycin

Condition Hierarchy (Ancestors)

Infections; Otitis; Ear Diseases; Otorhinolaryngologic Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• ICD CSD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 13, 2006
• First Posted: April 17, 2006
• Study Start: January 1, 2006
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: April 3, 2009

Record last verified: 2009-04

Locations

CZ (1); CO (1); AR (1); US (1); CL (1); BR (1); GU (1); DO (1); IL (1); PA (1); PE (1); CA (1)