TELI COM - Telithromycin in Children With Otitis Media

• Status: Terminated
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Azithromycin; Telithromycin

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.