Status:
COMPLETED
Efficacy Study of Pristinamycin Versus Amoxicillin to Treat Tonsillitis Induced by Streptococcus in Children
Lead Sponsor:
Sanofi
Conditions:
Tonsillitis
Eligibility:
All Genders
6-25 years
Phase:
PHASE3
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 v...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
395 Patients enrolled
Trial Details
Trial ID
NCT00393744
Start Date
October 1 2006
Last Update
March 17 2009
Active Locations (1)
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1
Sanofi-Aventis
Paris, France