Status:
TERMINATED
TELI TON - Telithromycin in Tonsillitis
Lead Sponsor:
Sanofi
Conditions:
Tonsillitis
Pharyngitis
Eligibility:
All Genders
6-13 years
Phase:
PHASE3
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 pyoge...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
314 Patients enrolled
Trial Details
Trial ID
NCT00315042
Start Date
March 1 2006
End Date
August 1 2006
Last Update
April 3 2009
Active Locations (5)
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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