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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Amoxicillin; Pristinamycin

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.