TELI TAD - Telithromycin in Tonsillitis in Adolescents and Adults

Pharyngitis Clinical Trial

Official title:

Multinational, Randomized, Double Blind, Comparative Study to Evaluate the Efficacy and Safety of 5 Days Telithromycin 800 mg od Versus 10 Days Penicillin V 500 mg Tid in Adolescent and Adult Subjects Equal to or Over 13 Years With Streptococcus Pyogenes Tonsillitis/Pharyngitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00315549
• Other study ID #: EFC6134
• Secondary ID: HMR3647B/3006
• Status: Terminated
• Phase: Phase 3
• First received: April 14, 2006
• Last updated: April 2, 2009
• Start date: February 2006
• Est. completion date: September 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, comparator-controlled, 2 parallel treatment group study in subjects equal to or over 13 years of age, with Streptococcus pyogenes tonsillitis/pharyngitis (T/P). Each subject will receive either telithromycin, 400 mg over-encapsulated tablets, 800 mg once daily for 5 days or penicillin V 250 mg over-encapsulated tablets, 500 mg three times daily for 10days. Matching placebo capsules will be dispensed to maintain the blind between the treatment groups.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: 233
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

Inclusion Criteria:

Age equal to or over 13 years;

• For female subjects, the following conditions are to be met:

• Subject is premenarchal or surgically incapable of bearing children,

• Subject is of childbearing potential and all of the following conditions are met:

• Have normal menstrual flow within 1 month before study entry,

• Have negative pregnancy test (urine pregnancy test sensitive to at least 50 mU/mL, and

• Must agree to use an accepted method of contraception throughout the study (if sexually active);

• Clinical diagnosis of acute tonsillitis/pharyngitis caused by Streptococcus pyogenes based on:

• A positive result from a rapid detection 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;

• 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

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

• Penicillin

Locations

Country	Name	City	State
Argentina	Sanofi-Aventis	San Isidro	Buenos Aires
Chile	Sanofi-Aventis	Providencia	Santiago
Costa Rica	Sanofi-Aventis	San Jose
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, 

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 insubjects 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 insubjects at the posttherapy/test-of-cure (TOC) visit andlate posttherapy visit (Visit 4) in the bacteriologic modified intent to treat population.