Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT #: 2006-002127-16 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pristinamycin | Drug | 50 mg/kg/d in 2 doses for children, and 1g twice daily in adults for 4 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| bacterial eradication | at V3 |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | during the study |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marie SEBILLE, Dr | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis | Paris | France |
Not provided
| ID | Term |
|---|---|
| D014069 | Tonsillitis |
| ID | Term |
|---|---|
| D010612 | Pharyngitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D025762 | Pristinamycin |
| D000658 | Amoxicillin |
| ID | Term |
|---|---|
| D025361 | Streptogramins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| amoxicillin |
| Drug |
50 mg/kg/d in 2 doses in children and 1 g twice daily in adults for 6 days |
|
| D009057 |
| Stomatognathic Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |