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

Primary Purpose

Tonsillitis

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
pristinamycin
amoxicillin
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tonsillitis

Eligibility Criteria

6 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

bacterial eradication

Secondary Outcome Measures

adverse events

Full Information

First Posted
October 27, 2006
Last Updated
March 16, 2009
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00393744
Brief Title
Efficacy Study of Pristinamycin Versus Amoxicillin to Treat Tonsillitis Induced by Streptococcus in Children
Acronym
PRI-angine
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 Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tonsillitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
395 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
pristinamycin
Intervention Description
50 mg/kg/d in 2 doses for children, and 1g twice daily in adults for 4 days
Intervention Type
Drug
Intervention Name(s)
amoxicillin
Intervention Description
50 mg/kg/d in 2 doses in children and 1 g twice daily in adults for 6 days
Primary Outcome Measure Information:
Title
bacterial eradication
Time Frame
at V3
Secondary Outcome Measure Information:
Title
adverse events
Time Frame
during the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie SEBILLE, Dr
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Paris
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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