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

NCT00393744 | Completed Phase 3

• 2 other identifiers: PRIST_L_01683EudraCT #: 2006-002127-16
• Study Type: interventional
• Target: 395
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• bacterial eradication

  at V3

Secondary Outcomes (1)

• adverse events

  during the study

Study Arms (2)

1

EXPERIMENTAL

Drug: pristinamycin

2

ACTIVE COMPARATOR

Drug: amoxicillin

Interventions

pristinamycin DRUG

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

1

amoxicillin DRUG

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

2

Eligibility Criteria

• Age: 6 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 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:

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Paris, France

Location

MeSH Terms

Conditions

Tonsillitis

Interventions

Pristinamycin; Amoxicillin

Condition Hierarchy (Ancestors)

Pharyngitis; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Streptogramins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Marie SEBILLE, Dr

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 27, 2006
• First Posted: October 30, 2006
• Study Start: October 1, 2006
• Primary Completion: March 1, 2008
• Last Updated: March 17, 2009

Record last verified: 2009-03

Locations

FR (1)