TELI COM - Telithromycin in Children With Otitis Media

Otitis Media, Suppurative Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00315003
• Other study ID #: EFC6132
• Secondary ID: HMR3647B/3002
• Status: Terminated
• Phase: Phase 3
• First received: April 13, 2006
• Last updated: April 2, 2009
• Start date: January 2006
• Est. completion date: July 2006

Study information

• Verified date: April 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Ethics Review CommitteeArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaChile: Instituto de Salud Pública de ChilePeru: General Directorate of Pharmaceuticals, Devices, and Drugs
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1500
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 6 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Otitis
• Otitis Media
• Otitis Media, Purulent
• Otitis Media, Suppurative

Intervention

Drug:
• Telithromycin

• Azithromycin

Locations

Country	Name	City	State
Argentina	Sanofi-Aventis	Buenos Aires
Brazil	Sanofi-Aventis	Sao Paulo
Canada	Sanofi-Aventis	Laval
Chile	Sanofi-Aventis	Providencia	Santiago
Colombia	Sanofi-Aventis	Santafe de Bogota
Costa Rica	Sanofi-Aventis	San José
Czech Republic	Sanofi-Aventis	Praha
Dominican Republic	Sanofi-Aventis	Santo-Domingo
Guatemala	Sanofi-Aventis	Guatemala
Israel	Sanofi-Aventis	Israel
Panama	Sanofi-Aventis	Panama
Peru	Sanofi-Aventis	Lima
United States	Sanofi-Aventis	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  Chile,  Colombia,  Costa Rica,  Czech Republic,  Dominican Republic,  Guatemala,  Israel,  Panama,  Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy variables will be time to symptom resolution (TSR) and clinical cure at theposttherapy/TOC Visit 3.
Secondary	Adverse events (AEs) reported by subjects, their parents/legally authorized representative, orobserved by the investigators will be recorded throughout the study.