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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00393744
First received: October 27, 2006
Last updated: March 16, 2009
Last verified: March 2009
  Purpose

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 Intervention Phase
Tonsillitis
Drug: pristinamycin
Drug: amoxicillin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • bacterial eradication [ Time Frame: at V3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • adverse events [ Time Frame: during the study ] [ Designated as safety issue: Yes ]

Enrollment: 395
Study Start Date: October 2006
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00393744

Locations
France
Sanofi-Aventis
Paris, France
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Marie SEBILLE, Dr Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00393744     History of Changes
Other Study ID Numbers: PRIST_L_01683, EudraCT #: 2006-002127-16
Study First Received: October 27, 2006
Last Updated: March 16, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Tonsillitis
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Amoxicillin
Pristinamycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014