Tonsillitis Clinical Trial
— PRI-angineOfficial 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.
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.
Status | Completed |
Enrollment | 395 |
Est. completion date | |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Years to 25 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Sanofi-Aventis | Paris |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | bacterial eradication | at V3 | No | |
Secondary | adverse events | during the study | Yes |
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