TELI COM - Telithromycin in Children With Otitis Media

Condition(s) targeted: Otitis Media, Suppurative; Otitis Media, Purulent

Intervention: Telithromycin (Drug); Azithromycin (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Sanofi-Aventis

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.

Official title: 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

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

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

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

Minimum age: 6 Months. Maximum age: 6 Years. Gender(s): Both.

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.

Sanofi-Aventis, Buenos Aires 1642, Argentina

Sanofi-Aventis, Sao Paulo 05677-000, Brazil

Sanofi-Aventis, Laval, Canada

Sanofi-Aventis, Columbia, Colombia

Sanofi-Aventis, San José, Costa Rica

Sanofi-Aventis, Praha 160 00, Czech Republic

Sanofi-Aventis, Santo-Domingo, Dominican Republic

Sanofi-Aventis, Guatemala, Guatemala

Sanofi-Aventis, Israel, Israel

Sanofi-Aventis, Panama, Panama

Sanofi-Aventis, Lima, Peru

Sanofi-Aventis, Bridgewater, New Jersey 08807, United States

Sanofi-Aventis, Providencia, Santiago, Chile

Starting date: January 2006
Last updated: March 7, 2008