Efficacy Study of Pristinamycin Versus Amoxicillin to Treat Tonsillitis Induced by Streptococcus in Children (PRI-angine)

Sanofi

Status and phase

Completed

Phase 3

Conditions

Tonsillitis

Treatments

Drug: amoxicillin

Drug: pristinamycin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00393744

EudraCT #: 2006-002127-16

PRIST_L_01683

Details and patient eligibility

About

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.

Enrollment

395 patients

Sex

All

Ages

6 to 25 years old

Volunteers

No Healthy Volunteers

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.