Status:
TERMINATED
TELI TAD - Telithromycin in Tonsillitis in Adolescents and Adults
Lead Sponsor:
Sanofi
Conditions:
Tonsillitis
Pharyngitis
Eligibility:
All Genders
13+ years
Phase:
PHASE3
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/p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
233 Patients enrolled
Trial Details
Trial ID
NCT00315549
Start Date
February 1 2006
End Date
September 1 2006
Last Update
April 3 2009
Active Locations (4)
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1
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis
San Isidro, Buenos Aires, Argentina, 1642
3
Sanofi-Aventis
Providencia, Santiago Metropolitan, Chile
4
Sanofi-Aventis
San José, Costa Rica