NCT00393744CompletedPhase 3
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.
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 395
- Locations
- 1
- Primary Endpoint
- bacterial eradication
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 25 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
1
Experimental
Intervention: pristinamycin (Drug)
2
Active Comparator
Intervention: amoxicillin (Drug)
Outcomes
Primary Outcomes
bacterial eradication
Time Frame: at V3
Secondary Outcomes
- adverse events(during the study)
Investigators
Study Sites (1)
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