Trial record 5 of 55 for:    Tonsillitis

TELI TAD - Telithromycin in Tonsillitis in Adolescents and Adults

This study has been terminated.
(Pediatric development program terminated by sponsor)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00315549
First received: April 14, 2006
Last updated: April 2, 2009
Last verified: April 2009
  Purpose

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 Intervention Phase
Tonsillitis
Pharyngitis
Drug: Telithromycin
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, 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

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 insubjects 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 insubjects at the posttherapy/test-of-cure (TOC) visit andlate posttherapy visit (Visit 4) in the bacteriologic modified intent to treat population.

Enrollment: 233
Study Start Date: February 2006
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00315549

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 Jose, Costa Rica
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: NCT00315549     History of Changes
Other Study ID Numbers: EFC6134, HMR3647B/3006
Study First Received: April 14, 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 July 29, 2014