Efficacy Study of Pristinamycin Versus Amoxicillin to Treat Tonsillitis Induced by Streptococcus in Children

Inclusion criteria

• subjects of both sexes
• aged between 6 and 25 years,
• weight : ≥ 20kg
• with suspected GAS-induced tonsillitis (erythema and/or exudate of the pharynx and/or tonsils with oropharyngeal pain and/or odynophagia, fever ³ 38°C, appreciable satellite adenopathy)
• confirmation by positive RDT
• provision of throat swabs for culture
• ability to swallow tablets

Exclusion criteria

• Related to the study disease:

• suspected viral infection (concomitant dysphonia, cough, conjunctivitis, rhinitis)
• adenophlegmon, peritonsillar abscesses.
• Related to the study treatment:

• known or suspected allergy to beta-lactamines (penicillin, cephalosporin)
• suspected infectious mononucleosis (increased risk of skin disorders)
• phenylketonuria (due to the presence of aspartame)
• congenital galactosaemia, glucose/galactose malabsorption syndrome, lactase deficiency (due to the presence of lactose, in powder or suspension form)
• allergy to pristinamycin and/or virginiamycin
• history of pustular rash with pristinamycin
• hypersensitivity or gluten intolerant (due to the presence of wheat starch)
• ongoing treatment with cyclosporine, methotrexate, colchicine, allopurinol, tacrolimus or oral anticoagulants.
• Related to previous treatment:

• subjects receiving antibiotic therapy in the month prior to inclusion, except for azithromycin, for which the exclusion period is 3 months.
• subjects on short-term corticosteroids. Subjects on long-term corticosteroids initiated before the start of the study and taken at a controlled dosage may be included.
• Related to subjects:

• breast-feeding women
• women either pregnant or attempting to conceive
• subjects likely, during the course of the study to receive treatments prohibited by the protocol
• treatment with other investigational drugs in the 4 weeks prior to inclusion in the study
• immunodepression, clinically significant endocrine disease, cardiovascular disease, neurological disease, or any other marked diseases resulting in complications in performance of the study or interpretation of the study data
• known hepatic impairment
• known renal impairment (creatinine clearance < 30 ml/minute)
• cancer, blood dyscrasias
• previous history of drug or alcohol abuse.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.