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TELI COM - Telithromycin in Children With Otitis Media

This study has been terminated.
(Pediatric development program terminated by sponsor)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00315003
First received: April 13, 2006
Last updated: April 2, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention Phase
Otitis Media, Suppurative
Otitis Media, Purulent
Drug: Telithromycin
Drug: Azithromycin
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

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

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

Estimated Enrollment: 1500
Study Start Date: January 2006
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   6 Months to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315003

Locations
United States, New Jersey
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807
Argentina
Sanofi-Aventis
Buenos Aires, Argentina, 1642
Brazil
Sanofi-Aventis
Sao Paulo, Brazil, 05677-000
Canada
Sanofi-Aventis
Laval, Canada
Chile
Sanofi-Aventis
Providencia, Santiago, Chile
Colombia
Sanofi-Aventis
Santafe de Bogota, Colombia
Costa Rica
Sanofi-Aventis
San José, Costa Rica
Czech Republic
Sanofi-Aventis
Praha, Czech Republic, 160 00
Dominican Republic
Sanofi-Aventis
Santo-Domingo, Dominican Republic
Guatemala
Sanofi-Aventis
Guatemala, Guatemala
Israel
Sanofi-Aventis
Israel, Israel
Panama
Sanofi-Aventis
Panama, Panama
Peru
Sanofi-Aventis
Lima, Peru
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00315003     History of Changes
Other Study ID Numbers: EFC6132, HMR3647B/3002
Study First Received: April 13, 2006
Last Updated: April 2, 2009
Health Authority: United States: Food and Drug Administration
Canada: Ethics Review Committee
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Chile: Instituto de Salud Pública de Chile
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs

Keywords provided by Sanofi:
Otitis Media
Suppurative
Purulent
Ketolide
Azithromycin
Telithromycin
Controlled Clinical Trials

Additional relevant MeSH terms:
Otitis
Otitis Media
Otitis Media, Suppurative
Suppuration
Ear Diseases
Infection
Inflammation
Otorhinolaryngologic Diseases
Pathologic Processes
Telithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014