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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Tonsillitis

Intervention / Treatment
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* Drug: pristinamycin
* Drug: amoxicillin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: pristinamycin<br>* 50 mg/kg/d in 2 doses for children, and 1g twice daily in adults for 4 days<br>|
| Active Comparator: 2<br> | Drug: amoxicillin<br>* 50 mg/kg/d in 2 doses in children and 1 g twice daily in adults for 6 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bacterial eradication |  | at V3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events |  | during the study |