Tonsillitis
Conditions
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.
Interventions
DRUGpristinamycin
50 mg/kg/d in 2 doses for children, and 1g twice daily in adults for 4 days
DRUGamoxicillin
50 mg/kg/d in 2 doses in children and 1 g twice daily in adults for 6 days
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 25 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| bacterial eradication | at V3 |
Secondary
| Measure | Time frame |
|---|---|
| adverse events | during the study |
Countries
France
Outcome results
None listed