TELI COM - Telithromycin in Children With Otitis Media

NCT ID: NCT00315003

Last Updated: 2009-04-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 1500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2006-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Telithromycin

Intervention Type: DRUG

Azithromycin

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

ICD CSD

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis

Bridgewater, New Jersey, United States

Sanofi-Aventis

Buenos Aires, , Argentina

Sanofi-Aventis

São Paulo, , Brazil

Sanofi-Aventis

Laval, , Canada

Sanofi-Aventis

Providencia, Santiago Metropolitan, Chile

Sanofi-Aventis

Bogotá, , Colombia

Sanofi-Aventis

San José, , Costa Rica

Sanofi-Aventis

Prague, , Czechia

Sanofi-Aventis

Santo Domingo, , Dominican Republic

Sanofi-Aventis

Guatemala City, , Guatemala

Sanofi-Aventis

Israel, , Israel

Sanofi-Aventis

Panama City, , Panama

Sanofi-Aventis

Lima, , Peru

Countries

United States; Argentina; Brazil; Canada; Chile; Colombia; Costa Rica; Czechia; Dominican Republic; Guatemala; Israel; Panama; Peru

Other Identifiers

HMR3647B/3002

Identifier Type: -

Identifier Source: secondary_id

EFC6132

Identifier Type: -

Identifier Source: org_study_id