Efficacy Study of Pristinamycin Versus Amoxicillin to Treat Tonsillitis Induced by Streptococcus in Children (PRI-angine)

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.

Study Overview

• Status: Completed
• Conditions: Tonsillitis
• Intervention / Treatment: Drug: pristinamycin; Drug: amoxicillin

• Study Type: Interventional
• Enrollment (Actual): 395
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Sanofi-Aventis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 23 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: pristinamycin; 50 mg/kg/d in 2 doses for children, and 1g twice daily in adults for 4 days
Active Comparator: 2	Drug: amoxicillin; 50 mg/kg/d in 2 doses in children and 1 g twice daily in adults for 6 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
bacterial eradication	at V3

Secondary Outcome Measures

Outcome Measure	Time Frame
adverse events	during the study

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Marie SEBILLE, Dr, Sanofi

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: October 27, 2006
• First Submitted That Met QC Criteria: October 27, 2006
• First Posted (Estimate): October 29, 2006

Study Record Updates

• Last Update Posted (Estimate): March 17, 2009
• Last Update Submitted That Met QC Criteria: March 16, 2009
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pharyngitis; Tonsillitis; Anti-Infective Agents; Anti-Bacterial Agents; Amoxicillin; Pristinamycin
• Other Study ID Numbers: PRIST_L_01683; EudraCT #: 2006-002127-16