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

Official Title: “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.

Intervention(s) in this Clinical Trial

• Drug: pristinamycin
  • 50 mg/kg/d in 2 doses for children, and 1g twice daily in adults for 4 days
• Drug: amoxicillin
  • 50 mg/kg/d in 2 doses in children and 1 g twice daily in adults for 6 days

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• bacterial eradication
  • Time Frame: at V3
    Safety Issue?: No

Secondary Measures

• adverse events
  • Time Frame: during the study
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 25 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Sanofi-Aventis Industry

Overall Clinical Trial Officials and Contacts

Marie SEBILLE, Dr Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00393744

Study ID Number: PRIST_L_01683

ClinicalTrials.gov Identifier: NCT00393744

Health Authority: France: Afssaps - French Health Products Safety Agency