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

NCT ID: NCT00393744

Last Updated: 2009-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 395 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31

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.

Conditions

Tonsillitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

pristinamycin

Intervention Type: DRUG

50 mg/kg/d in 2 doses for children, and 1g twice daily in adults for 4 days

2

Group Type: ACTIVE_COMPARATOR

amoxicillin

Intervention Type: DRUG

50 mg/kg/d in 2 doses in children and 1 g twice daily in adults for 6 days

Interventions

pristinamycin

50 mg/kg/d in 2 doses for children, and 1g twice daily in adults for 4 days

Intervention Type: DRUG

amoxicillin

50 mg/kg/d in 2 doses in children and 1 g twice daily in adults for 6 days

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Marie SEBILLE, Dr

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis

Paris, , France

Countries

France

Other Identifiers

EudraCT #: 2006-002127-16

Identifier Type: -

Identifier Source: secondary_id

PRIST_L_01683

Identifier Type: -

Identifier Source: org_study_id