Resumen

Este es un estudio multinacional, aleatorizado (1:1), doble ciego, doble simulacro, con comparador activo, de 2 grupos de tratamiento en paralelo, en sujetos de 6 meses a menos de 13 años de edad, con amigdalitis/faringitis (A/F) por Streptococcus pyogenes. Cada sujeto recibirá telithromycin 25 mg/kg una vez al día durante 5 días o penicillin V 13,3 mg/kg tres veces al día durante 10 días. Se dispensarán también placebos correspondientes a telithromycin y penicillin V durante 5 y 10 días respectivamente, para garantizar el cegamiento de los distintos regímenes de tratamiento. Se requerirá un resultado positivo en la prueba rápida de identificación del antígeno estreptocócico del grupo A en todos los sujetos en la Visita 1 (Día 1) para el ingreso al estudio. Se obtendrán muestras de hisopado faríngeo para cultivo bacteriano, identificación y prueba de susceptibilidad antibiótica en las Visitas 1, 3 y 4.

Elegibilidad

Edad mínima: 6 MonthsEdad máxima: 13 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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.

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Telithromycin (HMR3647)

Penicillin

Ubicaciones

Sanofi-Aventis

Patrocinadores