TELI TON - Telithromycin in Tonsillitis

Pharyngitis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00315042
• Other study ID #: EFC6133
• Secondary ID: HMR3647B/3004
• Status: Terminated
• Phase: Phase 3
• First received: April 13, 2006
• Last updated: April 2, 2009
• Start date: March 2006
• Est. completion date: August 2006

Study information

• Verified date: April 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationChile: Instituto de Salud Pública de ChileArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 314
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 13 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pharyngitis
• Tonsillitis

Intervention

Drug:
• Telithromycin (HMR3647)

• Penicillin

Locations

Country	Name	City	State
Argentina	Sanofi-Aventis	San Isidro	Buenos Aires
Chile	Sanofi-Aventis	Providencia	Santiago
Costa Rica	Sanofi-Aventis	San José
Panama	Sanofi-Aventis	Panama
United States	Sanofi-Aventis	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Argentina,  Chile,  Costa Rica,  Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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