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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00393744
Recruitment Status : Completed
First Posted : October 29, 2006
Last Update Posted : March 17, 2009
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tonsillitis Drug: pristinamycin Drug: amoxicillin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 395 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : October 2006
Actual Primary Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis

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

Primary Outcome Measures :
  1. bacterial eradication [ Time Frame: at V3 ]

Secondary Outcome Measures :
  1. adverse events [ Time Frame: during the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00393744

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Paris, France
Sponsors and Collaborators
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Study Director: Marie SEBILLE, Dr Sanofi
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Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00393744    
Other Study ID Numbers: PRIST_L_01683
EudraCT #: 2006-002127-16
First Posted: October 29, 2006    Key Record Dates
Last Update Posted: March 17, 2009
Last Verified: March 2009
Additional relevant MeSH terms:
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Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents