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TELI TAD - Telithromycin in Tonsillitis in Adolescents and Adults

Primary Purpose

Tonsillitis, Pharyngitis

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Telithromycin
Penicillin
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tonsillitis focused on measuring Tonsillitis, pharyngitis, penicillin, telithromycin, ketolides, clinical trials

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis

Outcomes

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.

Full Information

First Posted
April 14, 2006
Last Updated
April 2, 2009
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00315549
Brief Title
TELI TAD - Telithromycin in Tonsillitis in Adolescents and Adults
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 Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Terminated
Why Stopped
Pediatric development program terminated by sponsor
Study Start Date
February 2006 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tonsillitis, Pharyngitis
Keywords
Tonsillitis, pharyngitis, penicillin, telithromycin, ketolides, clinical trials

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
233 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Telithromycin
Intervention Type
Drug
Intervention Name(s)
Penicillin
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
Sanofi-Aventis
City
San Isidro
State/Province
Buenos Aires
ZIP/Postal Code
1642
Country
Argentina
Facility Name
Sanofi-Aventis
City
Providencia
State/Province
Santiago
Country
Chile
Facility Name
Sanofi-Aventis
City
San Jose
Country
Costa Rica

12. IPD Sharing Statement

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TELI TAD - Telithromycin in Tonsillitis in Adolescents and Adults

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