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TELI TON - Telithromycin in Tonsillitis

Primary Purpose

Tonsillitis, Pharyngitis

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Telithromycin (HMR3647)
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

6 Months - 13 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis
  • 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 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

Full Information

First Posted
April 13, 2006
Last Updated
April 2, 2009
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00315042
Brief Title
TELI TON - Telithromycin in Tonsillitis
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 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
March 2006 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 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, 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.

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
314 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Telithromycin (HMR3647)
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 in subjects 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 in subjects 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
6 Months
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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.
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 José
Country
Costa Rica
Facility Name
Sanofi-Aventis
City
Panama
Country
Panama

12. IPD Sharing Statement

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TELI TON - Telithromycin in Tonsillitis

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