TELI TAD - Telithromycin in Tonsillitis in Adolescents and Adults

Conditions: Tonsillitis Pharyngitis
MedDRA version: 17.1Level: PTClassification code 10049140Term: PharyngotonsillitisSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2014-004631-39-Outside-EU/EEA

Lead Sponsor: Sanofi-aventis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 760

Inclusion Criteria

Patients equal to or over 13 years of age with the following inclusion criteria participated:
• Clinical diagnosis of acute tonsillitis/pharyngitis caused by Streptococcus pyogenes based on positive result from a rapid detection test for group A streptococcal antigen
• 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: 608
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 76
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 76

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.

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) in the per-protocol population for analysis of bacteriologic outcome (PPb).;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>;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>