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

Condition(s) targeted: Tonsillitis

Intervention: pristinamycin (Drug); amoxicillin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Sanofi-Aventis

Official(s) and/or principal investigator(s):
Monique COUDERC, Dr, Study Director, Affiliation: Sanofi-Aventis

Overall contact:
Public Registry MA France, Email: Public-Registry-MA-France@sanofi-aventis.com

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: 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.

Study design: Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

bacterial eradication at V3

bacterial eradication at V4

bacterial eradication of macrolide-resistant strains at V3 and V4

clinical recovery at V3 and V4

clinical/bacteriological correlation at V3 and V4

Minimum age: 6 Years. Maximum age: 25 Years. Gender(s): Both.

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.

Public Registry MA France, Email: Public-Registry-MA-France@sanofi-aventis.com

Sanofi-Aventis, Paris, France; Recruiting
Phone: 0800 222 555

Starting date: October 2006
Last updated: October 15, 2007