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

A Phase III, Open, Randomised, Multicentre Study Comparing the Efficacy and Safety of Pristinamycin, at Dosages of 50 mg/kg/d in 2 Doses for Children, and 1g Twice Daily in Adults for 4 Days Versus Amoxicillin at a Dosage of 50 mg/kg/d in 2 Doses in Children and 1 g Twice Daily in Adults for 6 Days, Consumed Orally, in the Treatment of Tonsillitis Induced by Group-A Beta-Haemolytic Streptococcus in Patients Aged Between 6 and 25 Years.

The primary objective of this study is to demonstrate the non-inferiority, at the assessment visit (V3 (D10/D14)), in terms of bacteriological efficacy of pristinamycin (PRI) administered for 4 days versus amoxicillin (AMX) administered for 6 days in the treatment of tonsillitis caused by GAS, in subjects aged between 6 and 25 in the per protocol (PP) group.

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.