TELI TON - Telithromycin in Tonsillitis
- Conditions
- Tonsillitis PharyngitisMedDRA version: 17.1Level: PTClassification code 10049140Term: PharyngotonsillitisSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2014-004630-26-Outside-EU/EEA
- Lead Sponsor
- Sanofi-aventis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 760
Patients between 6 months to less than 13 years of age with the following inclusion criteria participated:
• clinical diagnosis of acute tonsillitis/pharyngitis caused by S. pyogenes based on 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
• 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, and fever.
Are the trial subjects under 18? yes
Number of subjects for this age range: 760
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•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;
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary objective of this study was to compare the bacteriologic efficacy of 5 days of telithromycin to 10 days of penicillin V in subjects with baseline bacterial throat culture positive for Streptococcus pyogenes and repeat throat culture performed at the posttherapy/test-of-cure visit (Visit 3, Days 13 to 17) (per-protocol population for bacteriologic outcome [PPb]).<br><br><br>;Secondary Objective: -;Primary end point(s): • Percentage of patients according to bacteriological outcome in PPb population;Timepoint(s) of evaluation of this end point: • At posttherapy (Day 13-17)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Percentage of patients according to bacteriological outcome in mITT b population<br>• Percentage of patients according to bacteriological outcome in PPb population at late posttherapy<br>• Number of patients with adverse events of special interest<br><br>;Timepoint(s) of evaluation of this end point: • At posttherapy (Day 13-17) <br>• At late posttherapy (Day 38-45)<br>• Up to 7 days after end of treatment<br>