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TELI TAD - Telithromycin in Tonsillitis in Adolescents and Adults

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: NCT00315549
Recruitment Status : Terminated (Pediatric development program terminated by sponsor)
First Posted : April 18, 2006
Last Update Posted : April 3, 2009
Information provided by:

Brief Summary:
This is a multinational, randomized (1:1), double blind, comparator-controlled, 2 parallel treatment group study in subjects equal to or over 13 years of age, with Streptococcus pyogenes tonsillitis/pharyngitis (T/P). Each subject will receive either telithromycin, 400 mg over-encapsulated tablets, 800 mg once daily for 5 days or penicillin V 250 mg over-encapsulated tablets, 500 mg three times daily for 10days. Matching placebo capsules will be dispensed to maintain the blind between the treatment groups.A positive rapid identification test for streptococcal Group A antigen will be required for all subjects at Visit 1 (Day 1) for entry into the study. Throat swab specimens for bacterial culture, identification, and antibiotic-susceptibility testing will be taken at Visits 1, 3 and 4.

Condition or disease Intervention/treatment Phase
Tonsillitis Pharyngitis Drug: Telithromycin Drug: Penicillin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 233 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multinational, Randomized, Double Blind, Comparative Study to Evaluate the Efficacy and Safety of 5 Days Telithromycin 800 mg od Versus 10 Days Penicillin V 500 mg Tid in Adolescent and Adult Subjects Equal to or Over 13 Years With Streptococcus Pyogenes Tonsillitis/Pharyngitis
Study Start Date : February 2006
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. To compare the bacteriologic efficacy of 5-days of telithromycin to 10-days of penicillin V insubjects at the posttherapy/test-of-cure (TOC) visit in the per protocol population.

Secondary Outcome Measures :
  1. To compare the bacteriologic efficacy of 5-days of telithromycin to 10-days of penicillin V insubjects at the posttherapy/test-of-cure (TOC) visit andlate posttherapy visit (Visit 4) in the bacteriologic modified intent to treat population.

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.

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Age equal to or over 13 years;

  • For female subjects, the following conditions are to be met:
  • Subject is premenarchal or surgically incapable of bearing children,

    • Subject is of childbearing potential and all of the following conditions are met:
    • Have normal menstrual flow within 1 month before study entry,

      • Have negative pregnancy test (urine pregnancy test sensitive to at least 50 mU/mL, and
      • Must agree to use an accepted method of contraception throughout the study (if sexually active);
  • Clinical diagnosis of acute tonsillitis/pharyngitis caused by Streptococcus pyogenes based on:

    • A positive result from a rapid detection test for Group A streptococcal antigen and submission of a throat swab specimen for bacterial culture, identification, and antibiotic-susceptibility testing; and
    • A sore and scratchy throat and/or pain on swallowing (odynophagia) together with at least 2 of the following clinical signs:

      • Tonsil and/or pharyngeal erythema and/or exudate;
      • Cervical adenopathy;
      • Uvular edema;
      • Fever

Exclusion Criteria:

  • Symptoms that collectively suggest nonstreptococcal T/P (eg, laryngitis, coryza, conjunctivitis, diarrhea, cough);
  • History of positive throat culture for Streptococcus pyogenes in the absence of clinical signs and symptoms of T/P;
  • Infection of the deep tissues of the upper respiratory tract (eg, epiglottitis, retropharyngeal or buccal cellulitis, or abscess of the retropharynx, tonsil, or peritonsillar area) or of the suprapharyngeal respiratory tract and its connecting structures (eg, sinusitis, otitis media, or orbital/periorbital cellulitis);
  • History of rheumatic heart disease;
  • Known congenital prolonged QT syndrome;
  • Known or suspected uncorrected hypokalemia (≤3 mmol/L [mEq/L) or hypomagnesemia or bradycardia (<50 bpm);
  • Known impaired renal function, as shown by creatinine clearance ≤25 mL/min
  • Myasthenia gravis;
  • History of hypersensitivity or intolerance to macrolides, penicillins, or cephalosporins;
  • 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.
  • Is currently being treated with systemic antibacterials or has been treated with systemic antibacterials within 14 days prior to enrollment;
  • Has been treated with any investigational medication within the last 30 days;
  • Has been treated with rifampicin, phenytoin, carbamazepine, or St. John's wort within the last 2 weeks.

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): NCT00315549

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United States, New Jersey
Bridgewater, New Jersey, United States, 08807
San Isidro, Buenos Aires, Argentina, 1642
Providencia, Santiago, Chile
Costa Rica
San Jose, Costa Rica
Sponsors and Collaborators
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Study Director: ICD CSD Sanofi

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Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00315549    
Other Study ID Numbers: EFC6134
First Posted: April 18, 2006    Key Record Dates
Last Update Posted: April 3, 2009
Last Verified: April 2009
Keywords provided by Sanofi:
clinical trials
Additional relevant MeSH terms:
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Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents