TELI TON - Telithromycin in Tonsillitis

This study has been terminated.
(Pediatric development program terminated by sponsor)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00315042
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, 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 Intervention Phase
Tonsillitis
Pharyngitis
Drug: Telithromycin (HMR3647)
Drug: Penicillin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 314
Study Start Date: March 2006
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   6 Months to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00315042

Locations
United States, New Jersey
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807
Argentina
Sanofi-Aventis
San Isidro, Buenos Aires, Argentina, 1642
Chile
Sanofi-Aventis
Providencia, Santiago, Chile
Costa Rica
Sanofi-Aventis
San José, Costa Rica
Panama
Sanofi-Aventis
Panama, Panama
Sponsors and Collaborators
Sanofi
  More Information

No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00315042     History of Changes
Other Study ID Numbers: EFC6133, HMR3647B/3004
Study First Received: April 13, 2006
Last Updated: April 2, 2009
Health Authority: United States: Food and Drug Administration
Chile: Instituto de Salud Pública de Chile
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Sanofi:
Tonsillitis
pharyngitis
penicillin
telithromycin
ketolides
clinical trials

Additional relevant MeSH terms:
Tonsillitis
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Telithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014