TELI TON - Telithromycin in Tonsillitis

NCT00315042 | Terminated Phase 3

• 2 other identifiers: EFC6133HMR3647B/3004
• Study Type: interventional
• Target: 314
• Locations: 5 countries
• Sites: 5

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.

Conditions

Tonsillitis; Pharyngitis

Keywords

Tonsillitis; pharyngitis; penicillin; telithromycin; ketolides; clinical trials

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• 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

Interventions

Telithromycin (HMR3647) DRUG

Penicillin DRUG

Eligibility Criteria

• Age: 6 Months - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sanofi: lead

Study Sites (5)

Sanofi-Aventis

Bridgewater, New Jersey, 08807, United States

Location

Sanofi-Aventis

San Isidro, Buenos Aires, 1642, Argentina

Location

Sanofi-Aventis

Providencia, Santiago Metropolitan, Chile

Location

Sanofi-Aventis

San José, Costa Rica

Location

Sanofi-Aventis

Panama City, Panama

Location

MeSH Terms

Conditions

Tonsillitis; Pharyngitis

Interventions

telithromycin; Penicillins

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 13, 2006
• First Posted: April 17, 2006
• Study Start: March 1, 2006
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: April 3, 2009

Record last verified: 2009-04

Locations

CO (1); CL (1); PA (1); AR (1); US (1)