Clinical trial NCT00315042: TELI TON - Telithromycin in Tonsillitis
Official title: Multinational, Randomized, Double-Blind, Double Dummy, Comparative Study to Evaluate the Efficacy and Safety of 5 Days Telithromycin 25mg/kg od Versus 10 Days Penicillin V 13.3 mg/kg Tid in Children 6 Months to Less Than 13 Years With Streptococcus Pyogenes Tonsillitis/Pharyngitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Tonsillitis
Pharyngitis
Keywords: Tonsillitis
pharyngitis
penicillin
telithromycin
ketolides
clinical trials
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-04-17
Enrollment: 314
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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;
* 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.

Primary outcomes:
measure: 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
Secondary outcomes:
measure: 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 andlate posttherapy visit (Visit 4) in the bacteriologic modified intent to treat population
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis
state: New Jersey
city: San Isidro
country: Argentina
facility: Sanofi-Aventis
state: Buenos Aires
city: Providencia
country: Chile
facility: Sanofi-Aventis
state: Santiago
city: San José
country: Costa Rica
facility: Sanofi-Aventis
city: Panama
country: Panama
facility: Sanofi-Aventis
Study officials:
References: