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

Tonsillitis Clinical Trial

— PRI-angine  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00393744
• Other study ID #: PRIST_L_01683
• Secondary ID: EudraCT #: 2006-
• Status: Completed
• Phase: Phase 3
• First received: October 27, 2006
• Last updated: March 16, 2009
• Start date: October 2006

Study information

• Verified date: March 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 395
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 25 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tonsillitis

Intervention

Drug:
• pristinamycin
50 mg/kg/d in 2 doses for children, and 1g twice daily in adults for 4 days
• amoxicillin
50 mg/kg/d in 2 doses in children and 1 g twice daily in adults for 6 days

Locations

Country	Name	City	State
France	Sanofi-Aventis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bacterial eradication		at V3	No
Secondary	adverse events		during the study	Yes