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TELI TON - Telithromycin in Tonsillitis

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: NCT00315042
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, comparator-controlled, 2 parallel treatment group study in subjects from 6 months to < 13 years of age, with Streptococcus pyogenes tonsillitis/pharyngitis (T/P).Each subject will receive either telithromycin 25 mg/kg once daily for 5 days or penicillin V, 13.3 mg/kg three times daily for 10 days. Matching placebo for telithromycin and penicillin V will also be dispensed for 5 and 10 days respectively, to provide blinding to the different treatment regimens. 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 (HMR3647) Drug: Penicillin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 314 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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 10 Days Penicillin V 13.3 mg/kg Tid in Children 6 Months to Less Than 13 Years With Streptococcus Pyogenes Tonsillitis/Pharyngitis
Study Start Date : March 2006
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 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 in subjects 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 in subjects 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:   6 Months to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 6 months to less than 13 years of age (<13);
  • Clinical diagnosis of acute tonsillitis/pharyngitis caused by Streptococcus pyogenes based on:

    • A positive result from a rapid detection throat swab 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;
  • Females of childbearing potential (ie, have reached menarche);
  • Known congenital prolonged QT syndrome;
  • Known or suspected uncorrected hypokalemia (≤3 mmol/L [mEq/L]), or hypomagnesemia or bradycardia (<50 bpm);
  • Myasthenia gravis;
  • Known impaired renal function, as shown by creatinine clearance ≤25 mL/min
  • The subject:

    • Is being treated with drugs not permitted by the study protocol ie, cisapride, pimozide, astemizole, terfenadine, ergotamine, dihydroergotamine, Class IA (eg, quinidine and procainamide) or Class III (eg, dofetilide) antiarrhythmic agents, simvastatin, lovastatin and atorvastatin;
    • 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.
  • 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.

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): NCT00315042

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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 José, Costa Rica
Panama, Panama
Sponsors and Collaborators

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Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00315042    
Other Study ID Numbers: EFC6133
First Posted: April 17, 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