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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00393744 |
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 |
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Tonsillitis |
Drug: pristinamycin Drug: amoxicillin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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. |
Enrollment: | 395 |
Study Start Date: | October 2006 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: pristinamycin
50 mg/kg/d in 2 doses for children, and 1g twice daily in adults for 4 days
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2: Active Comparator |
Drug: amoxicillin
50 mg/kg/d in 2 doses in children and 1 g twice daily in adults for 6 days
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Ages Eligible for Study: | 6 Years to 25 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Related to the study disease:
Related to the study treatment:
Related to previous treatment:
Related to subjects:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
Study ID Numbers: | PRIST_L_01683, EudraCT #: 2006-002127-16 |
Study First Received: | October 27, 2006 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00393744 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Amoxicillin Otorhinolaryngologic Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Tonsillitis Stomatognathic Diseases Pristinamycin Pharyngeal Diseases |
Anti-Infective Agents Anti-Bacterial Agents Therapeutic Uses Pharmacologic Actions |