COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

TELI COM - Telithromycin in Children With Otitis Media

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00315003
Recruitment Status : Terminated (Pediatric development program terminated by sponsor)
First Posted : April 17, 2006
Last Update Posted : April 3, 2009
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Otitis Media, Suppurative Otitis Media, Purulent Drug: Telithromycin Drug: Azithromycin Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : January 2006
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   6 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00315003

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

Layout table for additonal information
Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00315003    
Other Study ID Numbers: EFC6132
First Posted: April 17, 2006    Key Record Dates
Last Update Posted: April 3, 2009
Last Verified: April 2009
Keywords provided by Sanofi:
Otitis Media
Controlled Clinical Trials
Additional relevant MeSH terms:
Layout table for MeSH terms
Otitis Media, Suppurative
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents