TELI TAD - Telithromycin in Tonsillitis in Adolescents and Adults

NCT ID: NCT00315549

Last Updated: 2009-04-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 233 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2006-09-30

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.

Conditions

Tonsillitis; Pharyngitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Telithromycin

Intervention Type: DRUG

Penicillin

Intervention Type: DRUG

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.

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

ICD CSD

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis

Bridgewater, New Jersey, United States

Sanofi-Aventis

San Isidro, Buenos Aires, Argentina

Sanofi-Aventis

Providencia, Santiago Metropolitan, Chile

Sanofi-Aventis

San José, , Costa Rica

Countries

United States; Argentina; Chile; Costa Rica

Other Identifiers

HMR3647B/3006

Identifier Type: -

Identifier Source: secondary_id

EFC6134

Identifier Type: -

Identifier Source: org_study_id