Trial record 8 of 55 for:    Tonsillitis

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014