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TELI TON - Telithromycin in Tonsillitis

2014-08-27 03:45:10 | BioPortfolio

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.

Study Design

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

Conditions

Tonsillitis

Intervention

Telithromycin (HMR3647), Penicillin

Location

Sanofi-Aventis
Bridgewater
New Jersey
United States
08807

Status

Terminated

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:45:10-0400

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PubMed Articles [147 Associated PubMed Articles listed on BioPortfolio]

Staphylococcus aureus in tonsils of patients with recurrent tonsillitis: prevalence, susceptibility profile, and genotypic characterization.

Bacterial tonsillitis is an upper respiratory tract infection that occurs primarily in children and adolescents. Staphylococcus aureus is one of the most frequent pathogens in the etiology of tonsilli...

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Ten percent of the population claims an allergy to penicillin, but 90% of these individuals are not allergic. Patients labeled as penicillin-allergic have higher medical costs, longer hospital stays, ...

Long-term outcomes of tonsillectomy for recurrent tonsillitis in adults.

There is uncertainty regarding the effectiveness of tonsillectomy for recurrent tonsillitis in the adult population. Several studies have described a reduced number and severity of tonsillitis episode...

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Recurrent tonsillitis in adults has a significant impact on patients' daily life and healthcare costs. Humoral immunodeficiency increases the susceptibility to recurrent infections. The purpose of thi...

Despite the Safety of Preoperative Cefazolin for Patients With Non-anaphylactic Penicillin Allergy, 20% of Practitioners Avoid Its Use.

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Medical and Biotech [MESH] Definitions

Inflammation of the tonsils, especially the PALATINE TONSILS but the ADENOIDS (pharyngeal tonsils) and lingual tonsils may also be involved. Tonsillitis usually is caused by bacterial infection. Tonsillitis may be acute, chronic, or recurrent.

Semisynthetic antibiotic prepared by combining the sodium salt of penicillin G with N,N'-dibenzylethylenediamine.

An enzyme catalyzing the hydrolysis of penicillin to penicin and a carboxylic acid anion. EC 3.5.1.11.

A broad-spectrum penicillin antibiotic used orally in the treatment of mild to moderate infections by susceptible gram-positive organisms.

Semisynthetic antibiotic prepared by combining penicillin G with PROCAINE.

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