Trial record 6 of 50 for:
Tonsillitis
Efficacy Study of Pristinamycin Versus Amoxicillin to Treat Tonsillitis Induced by Streptococcus in Children (PRI-angine)
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00393744
First received: October 27, 2006
Last updated: March 16, 2009
Last verified: March 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Tonsillitis |
Drug: pristinamycin Drug: amoxicillin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- bacterial eradication [ Time Frame: at V3 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- adverse events [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
| Enrollment: | 395 |
| Study Start Date: | October 2006 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: pristinamycin
50 mg/kg/d in 2 doses for children, and 1g twice daily in adults for 4 days
|
| Active Comparator: 2 |
Drug: amoxicillin
50 mg/kg/d in 2 doses in children and 1 g twice daily in adults for 6 days
|
Eligibility| Ages Eligible for Study: | 6 Years to 25 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Medical Affairs Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00393744 History of Changes |
| Other Study ID Numbers: | PRIST_L_01683, EudraCT #: 2006-002127-16 |
| Study First Received: | October 27, 2006 |
| Last Updated: | March 16, 2009 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Tonsillitis Pharyngitis Pharyngeal Diseases Stomatognathic Diseases Respiratory Tract Infections Respiratory Tract Diseases Otorhinolaryngologic Diseases |
Amoxicillin Pristinamycin Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013