TerminatedPhase 3

TELI TON - Telithromycin in Tonsillitis

Stopped: Pediatric development program terminated by sponsor

United States, Argentina, Chile314 participantsStarted 2006-03

Plain-language 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 pyogenes tonsillitis/pharyngitis (T/P).Each subject will receive either telithromycin 25 mg/kg once daily for 5 days or penicillin V, 13.3 mg/kg three times daily for 10 days. Matching placebo for telithromycin and penicillin V will also be dispensed for 5 and 10 days respectively, to provide blinding to the different treatment regimens. 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.

Who can participate

Age range6 Months – 13 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 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; * 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; * Know…

What they're measuring

To compare the bacteriologic efficacy of 5-days of telithromycin to 10-days of penicillin V in subjects at the posttherapy/test-of-cure (TOC) visit in the per protocol population

Trial details

NCT IDNCT00315042

SponsorSanofi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-08