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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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TELI TAD - Telithromycin in Tonsillitis in Adolescents and Adults

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Japanese Study Evaluating Safety, Efficacy and Acceptability of Telithromycin in Children With Infections

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PubMed Articles [119 Associated PubMed Articles listed on BioPortfolio]

Is Scottish Intercollegiate Guidelines Network guidance for GP management of tonsillitis suitable? A qualitative study.

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Miracle near 34th street: Wartime penicillin research at St John's University, NY.

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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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